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ChemoCentryx Inc (CCXI)
Q1Â 2020 Earnings Call
May 11, 2020, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, and welcome to the ChemoCentryx First Quarter 2020 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.
I would now like to turn the call over to Bill Slattery of Burns McClellan. Mr. Slattery, please go ahead.
William Slattery -- Vice President
Thank you. Good afternoon, and welcome to the ChemoCentryx First Quarter 2020 Financial Results Conference Call. Earlier this afternoon, the company issued a press release providing an overview of its financial results for the first quarter ended March 31, 2020. This press release, along with a few slides that you may find helpful while you listen to this call, are available on the Investor Relations section of the company's website at www.ChemoCentryx.com.
Joining me on the call today is Dr. Thomas Schall, President and Chief Executive Officer of ChemoCentryx, who will review the company's recent business and clinical progress. Following his comments, Susan Kanaya, Executive Vice President, Chief Financial and Administrative Officer of ChemoCentryx, will provide an overview of the company's financial highlights for the first quarter 2020 before turning the call back over to Tom for closing remarks.
During today's call, we will be making certain forward-looking statements, which those of you following the slides can see if you look at Slide 2. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These risks are described in the company's filings made with the Securities and Exchange Commission, including the company's annual report on Form 10-K filed on March 10, 2020. You are cautioned not to place undue reliance on these forward-looking statements, and ChemoCentryx disclaims any obligation to update such statements.
In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 2020. ChemoCentryx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this live conference call.
At this time, it is my pleasure to turn the call over to Tom Schall. Tom?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Bill, and good afternoon to everyone listening. Thank you for joining us on our first quarter 2020 conference call. It is only two months since I reported to you on our full-year 2019 results, how the world has changed since then. Before I start, let me express my heartfelt sympathy to all those who have suffered and especially to those who have lost loved ones during this pandemic and also my deep gratitude to healthcare workers who are battling heroically to save lives.
The destruction and depth of this current crisis reminds us of the fundamental importance of good health and sadly, how far short we are from a world in which we have even adequate remedies for many afflictions. Never has the need for continued innovation in the life sciences has been more clear despite the great strides of progress we have taken in the recent decades. It's no wonder biotech companies are classified as essential businesses. Our passion is to discover, develop and bring novel medicines to those suffering and dying from serious diseases.
The ChemoCentryx platform, as you can see from Slide 3, is based on selectively or precisely inhibiting a specific chemoattractant receptor for a given destructive inflammatory or autoimmune disease. Importantly, and entirely unlike most current standard therapy, we do this without suppressing the whole of the immune system.
A word about how the COVID-19 pandemic has affected our work. First, what has changed? Operationally, to protect our team and our community, since March, only a core team of our colleagues, such as our lab scientists and other essential on-site personnel, are working physically at headquarters. For others, we implemented a work-from-home policy. Overall, business continuity is good.
Second, what has not changed? Our momentum, our timing for filing the NDA, or new drug application, for avacopan and ANCA vasculitis, our commercial launch readiness campaign. For example, batches of avacopan are already under way, and we are not subject to supply chain interruptions that have so far developed as a result of COVID-19. We are confident that we have enough avacopan for a commercial launch in ANCA vasculitis. Our clinical trial progress has been largely unaffected as I will explain in more detail in a moment.
While part of this reflects the seriousness of the diseases we are targeting, we are also fortunate that in our current cycle of clinical trials, we were at or near complete enrollment when the full impact of this coronavirus pandemic began to set in. Yes, our momentum continues, and our balance sheet remains strong, supplying the fuel we need to drive forward relentlessly in pursuit of relief for patients suffering from serious orphan diseases.
With that introduction on how COVID-19 has impacted our business, I'll now update you on our progress in executing the goals previously set forth this year, starting with avacopan and ANCA vasculitis, and then moving on to our 2020 4-Sight program of top line data readouts from a further four clinical studies.
As I turn to avacopan on Slide 4, let me remind you how deadly ANCA-associated vasculitis is and why a new standard of care is so desperately needed. ANCA patients carry a shocking ninefold increased mortality risk compared to healthy people. Even more shocking is that current therapy of broad immunosuppression actually adds to that mortality risk. Sadly, this is highlighted in the current crisis. Many ANCA patients are considered high-risk for COVID-19, in part owing to the current immunosuppressive therapies they are on to treat the ANCA disease.
But relief may be on the way. Our dialogue with the FDA continues on track, and we are on schedule to file our NDA for avacopan mid this year. Our confidence that we will meet this target was high to start with and has grown with each week that passes. It is a confidence that is founded upon what we consider to be the superlative results achieved in the pivotal Phase III ADVOCATE clinical trial in which avacopan demonstrated statistical superiority in sustained disease remission during one year of treatment versus the current steroid-containing standard of care group. This exceeded most expectations since the trial was not powered for superiority. Overall, the ADVOCATE trial revealed a compelling value proposition for avacopan and ANCA in the form of an all-around ability to reduce the total burden of ANCA-related disease.
Notably, beyond bringing the disease symptoms into remission and sustaining people in remission, as mentioned above, in addition, avacopan therapy significantly reduced the illnesses associated with the use of steroids, significantly improved kidney function over 52 weeks and actually improved quality of life, in contrast to the deterioration in quality of life in those patients on the steroid-containing standard of care. Members of the ANCA patient and clinician communities relate that touch effects are unprecedented in the ANCA vasculitis field, bringing the hope for a new paradigm of therapy.
We plan to share expanded data from the ADVOCATE trial beginning next month at the major annual meetings of the European League Against Rheumatism, or EULAR, and at the European Renal Association European Dialysis and Transplant Association meeting, or ERA-EDTA. We also look forward to sharing additional peer-reviewed publications starting this year.
We are gearing up our organization in preparation for the potential commercial launch of avacopan in the U.S. Our maxim is growth in the service of innovation and patient health. Since the start of the new year, we have added dozens of new professionals to the ranks of ChemoCentryx. In recent months, for example, we have added two new senior VPs in tech operations and human resources as well as making other key executive and management hires in areas such as medical affairs, research operations, supply chain, quality, market access, including patient access, commercial analytics, managed care and more. All of these highly trained professionals are part of our intensified mission to achieve launch readiness and commercialization of avacopan in 2021.
Turning now to our 2020 4-Sight program, shown on Slide 5. We expect to announce during this quarter the top line results from our LUMINA-1 dose-ranging study of the orally administered selective CCR2 inhibitor, CCX140, in the treatment of focal segmental glomerular sclerosis, or FSGS. FSGS is a condition characterized by scarring in the glomeruli, the kidneys' filtration units, and it can lead to end-stage renal disease, requiring dialysis or even kidney transplantation. FSGS is an orphan disease indication that afflicts tens of thousands of people in the U.S. alone with over 5,400 new cases each year in this country. There are also approximately 1,000 kidney transplants annually involving FSGS patients. With their filtration system impaired, patients suffer from excess protein in the urine, proteinuria. There are as yet no approved drugs for FSGS. The company's CCX140 has been granted orphan drug designation in the U.S. for FSGS.
As you can see from Slide 6, the LUMINA-1 trial is a randomized, controlled Phase II dose-ranging trial of 46 patients with primary FSGS. The study set out to measure the impact of CCX140 when added to the background standard-of-care medication using three different doses and compared to background medication alone. The primary efficacy end point in the LUMINA-1 trial is a reduction in proteinuria after 12 weeks compared to a patient's baseline at time of entry. Owing to the expected release of top line results in Q2, we will not be commenting further on Lumina-1 today.
The second FSGS study, also a part of our 2020 4-Sight program is the LUMINA-2 trial. LUMINA-2 is a single arm, open-label study of primary FSGS patients who are very ill with a condition known as nephrotic syndrome, identified in our study as baseline proteinuria of greater than three grams or higher and typically considerably higher per day. This is a much rarer condition and patients are, as you would expect, generally much sicker, requiring quite intensive medical intervention. Patients receive escalating doses of CCX140 from five mg once-a-day to 15 mg twice a day. We are on track to report top line results in the second half of this year.
Turning back to avacopan and forward to Slide 7. We have exceeded our target by enrolling more than 400 patients in the Phase II AURORA clinical trial for the treatment of the chronic, disabling skin disease, hidradenitis suppurativa. HS is a disfiguring skin disorder driven by neutrophils that are thought to be activated by the C5a receptor. And I remind all that avacopan's mechanism of action is blocking the C5a receptor, thereby preventing destructive activation of neutrophils by C5a. The AURORA trial is a double-blind, placebo-controlled trial of patients with moderate to severe HS who are randomized to one of three arms. The primary end point will be assessed at 12 weeks using the hidradenitis suppurativa clinical response, or HiSCR.
During this COVID crisis, we are working particularly closely with regulatory agencies and individual sites to ensure the safety of patients for study visits and the integrity of clinical data. The large majority of our HS sites have stayed open for HS patients, in part reflecting the fact that this is a devastating and life-altering disease. We continually monitor progress and are on track to release the top line data in the third quarter of this year.
The versatile avacopan is also being studied in the fourth of our 2020 4-Sight program depicted on Slide 8, the ACCOLADE Phase II clinical trial of patients with the rare kidney disease, C3 glomerulopathy. C3G is a complement disregulated orphan kidney disease for which, again, there are no approved treatment options. Half of all the C3G patients experience kidney failures. There are two placebo-controlled blinded strata in the ACCOLADE trial, and I'll have more details on those in the next quarter's call. Given the rarity of this disease, I believe we have already amassed one of the largest, and perhaps indeed the largest, data set on C3G from a randomized, blinded, controlled clinical trial. The community of C3G experts is asking for the analysis of this data because there's a powerful belief that our trial will provide the definitive answer as to whether targeting the C5a receptor is the way forward to a clear clinical benefit in C3G.
Given the rarity of this disease and its devastating course and the fact that there are no FDA-approved therapies, we are rigorously protecting the integrity of the database with a view that it could be discussed in the context to potentially support conditional registration for C3G. Naturally, consultation with regulators will be essential in defining this path.
I started today by expressing gratitude for the healthcare workers who are on the frontlines of this pandemic. Before turning the call over to Susan Kanaya for the financial results, let me close by also thanking all my very dear colleagues at ChemoCentryx who are on the frontiers of medical science for their dedication. Through their efforts, we are moving ever closer to a goal of helping clinicians and patients and rewarding also the shareholders who have placed their trust in us.
Susan?
Susan M. Kanaya -- Executive Vice President, Chief Financial and Administrative Officer and Secretary
Thank you, Tom. Our first quarter 2020 financial results were included in our press release today and are summarized on Slide 9. Revenue was $6 million for the first quarter compared to $8.3 million for the same period in 2019. Research and development expenses were $19.3 million for the first quarter of 2020 compared to $15.4 million for the same quarter last year. This increase was primarily due to patient enrollment in the avacopan AURORA Phase IIb clinical trial in patients with HS and costs associated with preparing the new drug application for avacopan in ANCA vasculitis. These increases were partially offset by lower expenses associated with the now completed avacopan ADVOCATE Phase III and CCX140 LUMINA-1 Phase II clinical trials.
General and administrative expenses were $8.8 million for the first quarter of 2020 compared to $5.5 million in the same period last year. The increase was primarily due to higher employee-related expenses, including those associated with our avacopan ANCA vasculitis launch readiness efforts and higher professional fees. We recorded a net loss for the first quarter of $21.7 million compared to a net loss of $11.9 million in the first quarter of 2019. Total shares outstanding at March 31, 2020, were approximately 61.8 million shares, and we closed the quarter with $188.8 million in reported cash and investments. Tom?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Susan. To summarize, as you can see on Slide 10, we are getting close to our goal of filing our NDA for avacopan in ANCA vasculitis with the U.S. FDA. And our partner, Vifor Pharma, plan to submit a licensing application to the EMA later this year. We are scaling up our organization in preparation for commercialization in the U.S., and Vifor Pharma is making preparation for international markets.
Our 2020 4-Sight program of top line data starts with the LUMINA-1 results, which we expect to announce in the current quarter. The results of the LUMINA-2 study are expected in the second half of this year. We have exceeded our target in enrolling more than 400 patients in the AURORA trial of avacopan in HS, consistent with our plan to release top line data next quarter, Q3. We also expect to announce results of the ACCOLADE trial of avacopan in C3G by the end of the year. And we are in an enviable financial position.
The progress of our enterprise is encouraging even as it plays out against the backdrop of the current crisis. But crises pass, while contributions last. At ChemoCentryx, our resolve is firm. Our science propels us forward, irresistible in our need for discovery, ineluctable in the drive to medical innovation. The fire of our determination burns bright to illuminate the future where we see health and prosperity for our patients and for our shareholders alike.
With that, I will now turn the call back over to the operator and look forward to your questions. Operator?
Questions and Answers:
Operator
[Operator Instructions] And your first question comes from the line of Steve Seedhouse with Raymond James. Hello, Steve, your line is open. Steve, you may be on mute.
Okay. I'll just circle back. Your next question comes from the line of Michelle Gilson with Canaccord Genuity.
Michelle Gilson -- Canaccord Genuity -- Analyst
Hi, can you guys hear me?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Yes, Michelle, loud and clear. Thank you. Hello.
Michelle Gilson -- Canaccord Genuity -- Analyst
Hi, Tom. Hi, Susan.
Susan M. Kanaya -- Executive Vice President, Chief Financial and Administrative Officer and Secretary
Hi, Michelle.
Michelle Gilson -- Canaccord Genuity -- Analyst
Thanks for taking my question. I'm bummed for you guys that you guys can't move into your new facility. But I was hoping that you could answer for us what are the remaining gating factors for filing for avacopan as we kind of head into the middle of this year?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Michelle. We're right on plan. It's a massive document, as you can well imagine. So most of it has just been a mass action kind of exercise at this point. There are no extraordinary gating items. Things that we talked about in the past we're progressing we have indeed progressed very nicely. So as far as we know, we have no hang-ups in any of the critical path areas. CMC and the like have all gone well. So yes, I would say that, right now, it's just a matter of buttoning up the rest of the package and filing it certainly in time for our midyear deadline.
Michelle Gilson -- Canaccord Genuity -- Analyst
All right. And just also on hidradenitis suppurativa, obviously, HiSCR score is a complicated assessment and can't really be done by anyone that's not trained. So I was just wondering if you're foreseeing any sort of complications in assessing HiSCR score for the hidradenitis suppurativa study.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Yes. It's a very good question and very apt in these times. So a couple of things have worked in our favor. I'll back up a little bit to say that we were obsessive about training people in the HiSCR before we started the study, and they had to pass a certification in order to be able to start enrolling patients. We've also been very fanatic about the standardization of the score and how it's done, creating and encouraging absolutely the use of continuous worksheets and other records. All of this is by way of trying to eliminate some of the inherent variability in the HiSCR and to certainly control placebo response. So we've done all of those things.
And indeed, during the blinded part of the HiSCR determinations, as data came in blinded, we were -- we have been fanatic about monitoring the blinded assessments. And if something doesn't make sense in terms of HiSCR, our medical monitor is on the phone with those investigators, and they go back to the inconsistencies and they work them out. So training has been extreme. Standardization has been an object of obsession, and monitoring during the blinded phase has been another key feature. In such ways, we hope to have a HiSCR, which is meaningful and well within the normal variant -- variability of a score like that.
To the rest of your question, we were very fortunate in that the majority of our subjects had already enrolled in the AURORA trial and had, in fact, passed the 12-week primary end point prior to the major part of the pandemic. So although we know we will get more data, even the data we collected, still entirely blinded to us, by the way, but we knew that we had enough data for the primary end point already captured in the trial to have a reasonable power to ascertain the primary end point as planned. So that was the worst-case scenario, which obviously will not come to pass because we now know, for example, that the majority of the HS sites have stayed open. And we are also doing other things like making every effort to make sure HiSCR, or primary end point determination for those minority of folks that have yet to past 12 weeks, will happen as planned, that's number one. And we've made really good progress on that.
For -- occasionally, for -- there are ways to do the HiSCR, not as perfectly, one admits, but even with telemedicine, there's been some breakthroughs there. And we've worked carefully with agency guidance and advising the agency where we've been on where there will be any issues around HiSCR determinations. I will say, too, that we've availed ourselves of some home healthcare visits as well. All of this adds up to, I think, the reasonable supposition on our part based on evidence to date that we will be able to have the HiSCR data that matters to determine whether the drug is efficacious based on the 12-week primary end point. So I feel we're in pretty good shape with that.
Michelle Gilson -- Canaccord Genuity -- Analyst
Okay. Great. Just one more, if I can. Are you testing patients for COVID-19 in your avacopan clinical studies right now? I know we've talked about this on the last call, how C5a may be implicated. But I was just curious if you're testing patients to see if you do have some case studies supporting the mechanism there.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
We've got no formal testing program in the avacopan studies. If they're getting incidentally tested, those results will likely be entered into our records, obviously, and we could do some retrospective analysis. But no, Michelle, we're not doing a formalized study of testing patients, either for COVID-19 or for antibodies against same. So that's all I have to say about the studies with the ongoing avacopan work. We are very keenly interested in the mechanism of COVID lung damage.
And as you know and others know, C5a and C5a receptor certainly have been spotlighted as potentially playing a role, unproven but potentially, and we've been deeply considering whether there are twp -- a couple of programs, one in Europe, one in the U.S., that we might get involved in. But so far, we have not made a decision. And certainly, we'll alert the community if we opt to do so. But clearly, this crisis is lasting a little bit longer than anyone had hoped, and so there may be some more careful clinical work to be done with novel agents. At this point, we're not doing that work, but we'll certainly keep the community appraised if we opt to get involved.
Michelle Gilson -- Canaccord Genuity -- Analyst
Okay. Great. Thanks, Tom. And looking forward to LUMINA-1 data.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Michelle.
Operator
You have a question from the line of Steve Seedhouse with Raymond James.
Timur Ivannikov -- Raymond James -- Analyst
Yes. Hi, this is Timur Ivannikov for Steve. Can you hear me?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Yes. We can hear you just fine. Thank you.
Timur Ivannikov -- Raymond James -- Analyst
Okay. Yes, sorry about the technical difficulty. So we had a question about the AURORA HS study. You talked about enrollment exceeding expectations. Could you remind us what delta in HiSCR was the study powered for? And I'm assuming dropout rate hasn't been a problem. But could you just talk about whether it's been impacted by COVID-19?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Very good question. So the dropout rate certainly up to the week 12 primary end point should not, as I already alluded to, even under normal practice, should not affect our ability to detect a meaningful difference in the primary end point. We probably, over the longer term -- as you know, after the 12-week end point, folks in the trial go into an open-label phase, although they're two doses, and they're blinded to dose. So there will be additional data to be had from the 24-week additional period. And there, we do expect not to have quite as rich a dataset owing to COVID, which is only to be understood. Having said that, as I mentioned, the major actions in the first 12 weeks, I don't think, will be affected there and dropouts were more or less as predicted.
So we have -- obviously, this is a large trial, 390 patients in three groups, powered to look at about a 20% difference in HiSCR with greater than 90% power. So I think we're really adequately powered to a Phase III level. And that would be between any of the individual dose arms versus placebo, the even greater power, if we, in the stats plan, avail ourselves of additional analyses of pooling all patients on avacopan. So it's highly powered. And as I said, we've been very obsessive about HiSCR training, standardization and monitoring during the blinded phase. So I'm quite confident that we'll be able to determine a clinical response if we see one.
Timur Ivannikov -- Raymond James -- Analyst
Okay. Great. And our other question -- so it's about potential COVID-19 studies. You mentioned that you're potentially looking at getting involved, and now it seems that ChemoCentryx is sort of in a minority of companies that have complement inhibitors and have not yet initiated the clinical study in COVID-19. Could you maybe talk about some of the factors that will make you get involved in the programs you're considering? Thank you.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Well, it's a very interesting and important question. So notwithstanding that other complement intervention companies are involved, and although we get sometimes interesting hints that there may be things that are important happening in the clinic. I think ChemoCentryx, our -- we have a certain special -- certain circumstances are special with respect to timing of our program. So as you know, we've just completed the first large pivotal trial with interesting and, I think, very important positive results in ANCA vasculitis. The drug is not yet licensed, and yet we're now just applying for our first license. So the timing of avacopan and its ability to help people with known disease, with a large data set from a randomized controlled trial is something we carefully obviously consider in the equation.
Moreover, I think the biology of COVID is very interesting to us as well. And so, yes, there is some very reasonable hypothesis that morbidity and mortality driven by the acute lung injury in this virus and other related kind of viruses, the acute respiratory distress syndrome is certainly consistent with the complement activation of neutrophils and being involved in the so-called cytokine storm. But it is also true that complement is part of host defense, fundamentally, including viral host defense. So obviously, the timing of intervention is very, very key. And I don't think anyone in the world yet knows, a, whether or not the hypothesis is fundamentally driven at the level of excellence, mechanism evidence. But certainly, no one yet knows about the precise timing of intervention even if the hypothesis is one that one is strongly believing in.
So we do believe there's better evidence around that now. We do believe that there is a point of intervention. And there are a couple of much more carefully designed clinical programs that are, one, I think, has already been approved in the U.K., and they were evaluating whether we should be one of the agents. It will be a multi-agent study with very careful data collection, very careful controls and comparisons. So the elapse of time has allowed for more careful studies to be designed and more careful protocols to be constructed. So that's interesting to us. And it's also interesting to us that we -- now that we have a very good handle on our data package for the other programs, we can certainly devote a lot more time and attention to whether or not COVID intervention study is something that we could meaningfully make a contribution to.
So I acknowledge that we were not among the first companies to jump in at the very first moment of this crisis. And I think that while those contribution across the board, whether with complement intervention or other kind of interventions, have been very important and I applaud those sponsors, we've yet to get really good evidence from some of those early approaches about what is the way forward. So maybe we have a little bit more evidence now, a little bit more understanding of how to manage such trials. And so as I said, we're day-to-day involved in this analysis and the discussion, and we will, at the appropriate time, be involved if it is scientifically based in evidence and whether the trial can yield useful information in our opinion.
Timur Ivannikov -- Raymond James -- Analyst
Okay. Thank you very much.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you.
Operator
Your next question comes from the line of Anupam Rama with JPMorgan.
Tessa Thomas Romero -- JPMorgan -- Analyst
Hi, guys. This is Tessa on the call tonight for Anupam. Glad to hear you're all doing well. And thanks for taking the question. So I guess one from us, on ADVOCATE, you mentioned the plan, Tom, to present data at EULAR and ERA-EDTA next month. Could you just remind us what additional key analyses we should expect on ADVOCATE data? Any subgroup analyses we should be paying particular attention to? Thank you so much.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Tessa. Great question. So ERA, as well as EULAR, will be virtual meetings this year as probably most have guessed. But we have been confirmed at both those meetings. We, meaning the -- some of the key clinical investigators for presenting some of the data in, I think, fairly high-profile sessions. So as soon as we have the details of when those presentations will be released and in what form, we'll certainly alert everybody. The data will be, I think, very interesting because, as you know, we put out the top line data, and it's pretty clear that the results are very robust with avacopan. We have lots of people in a remitted state. When one looks at the primary end point based on the Birmingham Vasculitis Activity Score. At week 26, numerically better than the [Technical Issues]
A very good job of sustaining people under remission by six months. They are sustained in remission, sustained in remission at week 52 in a very statistically significantly superior way to the standard-of-care arm. So that's important. The numbers are very robust in that primary end point. So you can infer from the arithmetic that the subgroups are all doing well. But you're exactly right, we will be looking at subgroup analyses beyond the top line. So for example, we know we have [Technical Issues] background therapy. And again, the standard of care is always [Technical Issues]
That's usually associated with the clinical diagnosis of GPA. And the other auto antibody is anti-myeloperoxidase, which is typically associated with the clinical diagnosis of MPA. And there's some clinical distinctions between those two groups. MPA disease with anti-MPO antibody is much more highly related to very intractable kidney dysfunction, hard to manage patients, and so we'll be looking at that as well. So that's what physicians want to know. Will avacopan work with newly diagnosed as well as relapse disease? Will it work with GPA and MPA disease? And will it work with background therapy of cyclophosphamide or rituximab? So those details will be coming out in the subgroup analysis.
Again, I'll just give a quick preview. The arithmetic is so strong with avacopan at week 52. You can guess that everyone does well, and they do. So no one should be, in my opinion, excluded from the realm of potential avacopan therapy, should it get licensed. But some of the details that will come out of the subgroups, I think, are very interesting and tantalizing and, fundamentally, should change the discussion around what should become standard of care with people that have severe episodes of ANCA vasculitis, either newly diagnosed or major episodes of relapse. I think these data are going to really show -- they're really going to inform that conversation and, I believe, change it.
So I think those are the kinds of things you can look for to say nothing of a few more details on the prespecified secondary end points, the improvements in renal function that just steadily increases over 52 weeks and significantly superior to standard of care, the quality of life metrics as well as the Glucocorticoid Toxicity Index where, again, we showed a significant reduction in glucocorticoid-related effects. All those will be fleshed out a little bit at ERA and EULAR and, obviously, in the publications.
Operator
Your next question comes from the line of Ted Tenthoff with Piper Sandler.
Ted Tenthoff -- Piper Sandler -- Analyst
Great. Thanks. Hi, Tom. Hi, Susan. Thank you so much for taking my questions, and really congrats on all the progress, just a lot going on, and it's great to see you guys managing through this different -- difficult time period. I apologize if this question was asked, you were breaking up a little bit. So it was hard to hear some of the answers. But just with respect to AURORA, trying to get a sense for what the hurdle is here. What would you guys see as clinically meaningful? And what could be potentially next steps on positive data? Thanks so much.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Well, thank you, Ted. Those are really excellent questions. So one needs to keep in mind that currently, HS patients have only one licensed therapy, and that's adalimumab, or anti-TNF Humira. It certainly was an advance from what they had before that drug was licensed. But there are some limitations to that therapy. And in fact, most in the community would say that the benefits, particularly durable benefits, are fairly modest. Again, still important, no question, they are important. But they're fairly modest after a year's time, such that one can make very rough estimates based on some primary data that, that antibody is probably only accessing 10% to 15% of the moderate-to-severe patient population with hidradenitis suppurativa. Notwithstanding that, it still is commercially very successful in that indication despite the modest patient population penetration as well as the fairly modest durable effects.
So there's huge opportunity here. And moreover, as you know, it's an injectable. So what patients really want is an effective orally administered drug, and they're really clamoring for this. So the desire for an advance in therapy is, I would say, really considerable. Now what's clinically meaningful, we know from the only other controlled trials that adalimumab got approved when HiSCR showed about it anywhere between a 20% to 30% improvement or delta versus the placebo control arm. So again, by definition, the way it's set up and the way the regulatory precedent looks, that's clinically meaningful. So it's one thing we will be looking for is to assure that we -- and we set up the trial to assure that we have a good chance and are statistically powered to see what I think most people would consider to be a clinically meaningful delta.
So there are other things built into the trial. Of course, there's -- we've tried to adapt with the key opinion leaders and experts a quality-of-life index that's more tailored to the unique challenges of hidradenitis suppurativa patients. That will be read out as a secondary end point. There will be other biomarkers, of course. But if we were to see a statistical separation with the avacopan group versus the placebo group, fundamentally, I think that would be clinically meaningful. And if it is on the order of what we're seeing in the adalimumab trials at minimum, I think there would be -- when you talk about next step, there may actually be a meaningful discussion to be had with the FDA about potentially a conditional license given that we have a mature asset in other orphan areas.
Now orphan drug designation was given for early stage, two, three disease to the other sponsor, AbbVie, with adalimumab. We've been in an application process. We don't yet have orphan drug designation. But should we get that designation, maybe that would also be a reasonable discussion about whether or not registration could be achieved with robust data just with the AURORA trial. So that gives you an indication. But even if it doesn't, if that trial is positive, and there is not a discussion to be had about conditional registration, we believe fundamentally that any additional clinical trial that we would need to do could be extremely efficiently done. And I think we had a very, very good enrollment in this trial. Again, patients are clamoring for something new, particularly if it's orally available. So a confirmatory trial, if necessary, I think, could be done very rapidly and efficiently.
Ted Tenthoff -- Piper Sandler -- Analyst
Great. That's a very helpful update, I appreciate that.
Operator
Your next question comes from the line of Ed White with H.C. Wainwright.
Ed White -- H.C. Wainwright -- Analyst
Hi, Tom. Hi, Susan.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Hello, Ed.
Susan M. Kanaya -- Executive Vice President, Chief Financial and Administrative Officer and Secretary
Hi, Ed.
Ed White -- H.C. Wainwright -- Analyst
So just a question, Tom, you went into great detail on AURORA and what's being done to follow up on the patients with teleconferencing and perhaps home healthcare visits. Tom, just curious if you're implementing anything like that in any of your other studies.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
We have. Thank you, Ed. In most of the other studies -- although, yes, of course, we're being particularly careful as we look at patients, but the timing turned out to be less grievous for us than some others. So if you look across the programs that are most in focus, obviously, the ADVOCATE data was already done and the clinical conduct of that trial was finished other than closing out a few sites. So those site closures have been somewhat delayed, yes. But the real data collection and analysis and the things we needed to do to compile the new drug application package, those things were already in process. The FDA has also been working very hard to make sure that important programs that are going into a registration filing and evaluation, those have continued, I think, at pace. I've not seen any diminution in the capacity of the agency to work with those kind of programs. So ADVOCATE, avacopan and ANCA vasculitis, minimal effect.
LUMINA-1, the FSGS trial with CCX140, the last patient visit was just about happening around about the time or just into the real fullness of the crisis developing. So much of the data had been collected, I'd say the large majority. So again, the difficulties there were kind of tidying the ends of the study, and that still is difficult because we're working in 35 sites internationally in many different countries. But generally, that's not affected because we didn't have patients any longer in LUMINA-1 for all intents and purposes, so it really was not affected. LUMINA-2 is a much longer study, much smaller study, so a lot of the data had been collected from the folks that have already been done. There are one or two people we're still trying to get data on, and that's been a little more challenging because they are -- but they are hired intervention people. So they're coming into the clinic anyway. So strangely enough, it hasn't affected that too much.
And with C3G, yes, there was some consideration that we had to take in particular, since those patients are on a whole cocktail of immunosuppressants, especially if they've had a kidney transplant, and some of them have had transplant in the trial. But even there, we've been fortunate in being able to work very carefully with sites and make sure that folks could come in for their essential visits, their six-month visits at the clinic. That's worked out in the main very well. And there are blood draws and things for safety and monitoring, those have been worked on more with, again, remote visits, local hospitals, etc. So all in all, it has really been the AURORA trial as the largest trial that we've had to take the most intervention, although I will say that, to a smaller degree, similar measures have been taken in ACCOLADE as well. But to the extent that we will get the essential data, I think, in the fashion that we hope to, we're on track to do that with a combination of all the measures that I discussed.
Ed White -- H.C. Wainwright -- Analyst
Great. That's good news, Tom. Thank you. And then just the other question was now that you're talking about launch readiness, I'm just wondering if you can give us any initial feedback perhaps for avacopan from the managed care companies, the payers or even the physicians. Thanks.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Well, it's a great question. Not too many details today, regrettably, Ed. But rest assured, that is the intense focus of our work and background, and we'll have a lot more to say about that once we get the filing in and start discussing some of the more -- of the primary research and so on. Suffice it to say, I think if you talk to the physician community, if they have an awareness, there are a few, obviously, that have been confidentially looking at data beyond the top line, and this is the kind of data that will start to come out next month at ERA as well as EULAR. There is widespread enthusiasm again for how this drug might be used and we -- it's been very gratifying, the feedback. I do think it will change the conversation about the treatment paradigm in ANCA. And I think when you start talking to folks in the community, particularly after ERA and EULAR, I think you'll hear some of that enthusiasm.
So there's -- it's also interesting, too. I mean people -- ANCA vasculitis is not a household disease in terms of familiarity. But once people start looking at it and even scratching the surface, you see really very interesting data that comes out really early on. Many hospitalizations in the U.S. with ANCA in the chart are over 13,000. And that was a lot higher than I would have thought given that the incidence and prevalence combined is probably realistically somewhere between 60,000 to 75,000. You can get data as low as 45,000, as high as 105,000 in the U.S., but take somewhere in the middle. And of that, you've got 13,000-plus hospitalizations. And these are not short hospitalizations. These are well over a week. My team were -- unfortunately, some of these health economics conferences got canceled because we had some abstracts already accepted and presentations planned. So you'd be hearing about this data in more detail, at least some of the early stuff by now.
But yes, 10 to 11 days, and these are not cheap hospitalizations, either. They're well over 100,000, typically, on average. People getting a lot of death even with closest medical supervision, somewhere between a fourth to nearly 40% mortality in these hospitalizations and lots of serious infections, which, as you know, are not only tragic but very expensive. So I assure you that the health economics is really considerable and that some of the early data has been surprising to me, both in a good way for commercial opportunity but sadly for current patient care. I just think we're going to be able to make real contributions here, and I think that the opportunity on the commercial level will match some of that contribution that we make. So it's -- we'll have a lot more to say about that as the months go on and as we get closer to launch, Ed.
Ed White -- H.C. Wainwright -- Analyst
Great. Thanks very much, Tom.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
You're very welcome.
Operator
Your next question comes from the line of Joe Schwartz with SVB Leerink.
Joe Schwartz -- SVB Leerink -- Analyst
Great. Thank you so much. And it's great to hear you faring well. I was wondering if you could talk about your commercialization plan in terms of the number and type of personnel that you think you may need to sell and market avacopan and your status on that front?
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you, Joe. That's a really important and very good question. Yes. We've done quite a bit of work on this. And the expansion at ChemoCentryx, even in this environment, is considerable in the last two weeks. Much of it is focused on commercial readiness. We can work backwards from things like field force, for example, and physician access and what kind of physicians. So once diagnosed, Joe, most folks are seen by either rheumatologists or nephrologists in this malady. As the months progress a little bit more, and even the next couple of weeks, perhaps we'll say a little bit more about the potential and the division between rheumatologists and nephrologists. But those are the two main specialties. Once diagnosed, the patient journey to get the diagnosis is a little bit more tortuous than we thought, but we understand that journey a lot now. So we're preparing to make sure that we get patient access through the initial patient journey to diagnosis and then certainly hyperfocused once diagnosed on the rheumatology and nephrology communities.
We know a lot about where the current medication and prescriptions come from. The KOLs and their immediate circle of fewer than, say, around 250 physicians, probably account for 30% of U.S. prescriptions right now with current care. And we probably know, as a sponsor, we know, I'd say, a lot of those 250. So we're personally acquainted with a lot of the key movers already, and they are increasingly aware not just of our program but, obviously, the result of ADVOCATE. And ultimately, it may be as few as less than 3,000 physicians in the U.S. that will prescribe the lion's share, 80% or greater, of all medications in ANCA vasculitis each and every year. So that's not a huge number. We feel that a field force, a combination of classic sales reps as well as medical science liaison individuals and, of course, their support personnel, a field force of somewhere, let's just say, about 75 or so could be fewer, could be a few less, could be a few more. But not a huge field force can actually really saturate the 80% of those prescribers that I alluded to a moment ago.
So I think we're understanding a lot better the scope of the effort needed. And we have put together, as I said, already the infrastructure to really be a big player in this area in a way that's meaningful. And of course, these people are all being hired. Obviously, the field force folks will be coming in, in a staged fashion. But the people behind them, the ones that will make sure that we have all the market access, etc., and distribution, all of these things, those folks are already either hired or being hired basically continuously. So we will be ready for a launch in 2021, and we'll be ready for a very effective launch. We're taking this as job one and very seriously at the company.
Joe Schwartz -- SVB Leerink -- Analyst
That's very helpful. Thanks. And then on the pipeline, I was wondering if you could talk about the rationale to study two different FSGS populations in LUMINA-1 and 2 and how you think our priority about what you might see in each of these groups based on the mechanism of action and what's most relevant in these two subsets of patients, also nephrotic, versus nephrotic.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
The two populations are essentially -- officially, one is a sub-nephrotic. They're both primary FSGS populations. Primary can mean either that it is a genetic -- a known genetic lesion that predisposes to FSGS or, frankly, no other known cause of the FSGS. And that's what's considered primary. It's an -- for regulators, that's a pretty important distinction biologically or clinically just how important it actually is because, in fact, FSGS is not a disease per se, it's an indication based on a microscopic reading of the kidney, whether or not the glomeruli has -- is a focal part of scarring or scarring across the larger regions or segmental scarring. So it's an interesting area in which to work because the diagnosis is actually a microscope diagnosis, if you will and how those glomeruli came to be scarred is not always well understood. So -- but -- and as I mentioned, there's no approved therapy. So there's not -- there hasn't been the kind of breadth and depth of science clinically, although a lot of wonderful work has been done, make no mistake, but we just don't have great understanding of these patient populations.
Now when we went into the program, clearly, we wanted to understand the -- whether or not proteinuria reduction could occur with CCX140 as we have seen it to occur in other kinds of chronic kidney diseases, including diabetic nephropathy. And as any -- and as we've shown in animal models, and I've discussed this before, so I won't belabor it again. Other podocytopathies, which FSGS is considered to be, would also get relief with CCR2 inhibitor therapy. So with the populations we're studying, LUMINA-2 had so-called nephrotic syndrome levels of proteinuria. These people have really high levels of protein in their urine, and it's leaching out of their -- essentially their bloodstream, and that has a lot of consequences, including the fact that so much proteinuria is actually just an assault on what remains in the kidney in terms of its filtering capacity. So the clinical community and regulators are very keen to see if these nephrotic syndrome-level people, the patient population in the LUMINA-2 trial, if that can be controlled in any way, shape or form since that will likely have a very good and short-term impact on keeping them out of that end-stage renal disease.
So that is slightly different from LUMINA-1 population where they don't have this nephrotic level of proteinuria generally. So a little less sick, maybe less predisposed to the imminent threat of end-stage renal disease in LUMINA-1. As it turns out, in fact, the more experience you get with these folks, the LUMINA-2 people are just a different clinical picture entirely. Frequently, they are at the very end of all therapeutic options regrettably and sadly. So while in theory, we were trying to make this very nice abstract distinction between nephrotic and sub-nephrotic levels of proteinuria, in practice, the individuals are very, very ill with nephrotic levels of proteinuria. And instead of arresting them at a stage where before they try everything else, they actually would get on a CCX140 therapy, maybe the tendency is to get people to [Technical Issues]
So it's a very sick population. I don't know what the result will show. I have -- I do not have access to the data. But I know that we and other sponsors have found it very difficult to do meaningful work in the nephrotic syndrome segment of this population. So I consider that to be of different then with [Technical Issues] next step for a LUMINA trial that could lead to registration with proteinuria reduction after, say, six months, at least as a conditional time point, that will be a successful LUMINA-1 result. So we don't have that result yet, and I still don't have any data. But as soon as I know the result in very short order, then the community will have the result as well.
Joe Schwartz -- SVB Leerink -- Analyst
Thanks, Tom.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Thank you.
Operator
There are currently no other questions. I would now like to turn the call back to the CEO, Tom Schall, for closing remarks.
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Well, I just wish again to thank everybody for joining us during these very difficult times, and I appreciate all of the insightful questions and commentary, and I look forward to being able to update you on our next quarter conference call in a very few months. Thank you again for your time and attention.
Operator
[Operator Closing Remarks]
Duration: 67 minutes
Call participants:
William Slattery -- Vice President
Thomas J. Schall -- President, Chief Executive Officer and Chairman of the Board
Susan M. Kanaya -- Executive Vice President, Chief Financial and Administrative Officer and Secretary
Michelle Gilson -- Canaccord Genuity -- Analyst
Timur Ivannikov -- Raymond James -- Analyst
Tessa Thomas Romero -- JPMorgan -- Analyst
Ted Tenthoff -- Piper Sandler -- Analyst
Ed White -- H.C. Wainwright -- Analyst
Joe Schwartz -- SVB Leerink -- Analyst
