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Concert Pharmaceuticals, Inc. (CNCE)
Q4Â 2019 Earnings Call
Feb 27, 2020, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good morning, ladies and gentlemen. And welcome to the call to discuss Concert Pharmaceuticals Fourth Quarter 2019 Financial Results. [Operator Instructions] Later, we will conduct a question-and-answer session and instruction will flow at that time. [Operator Instructions]
I would now like to turn the conference over to your host Ms. Justine Koenigsberg, Senior Vice President of Corporate Communications and Investor Relations. Please go ahead.
Justine Koenigsberg -- Investor Relations
Thank you, Stephanie. Good morning and welcome to Concert Pharmaceuticals' fourth quarter 2019 investor update. Joining me this morning with prepared remarks are Roger Tung, our President and CEO; Jim Cassella, our Chief Development Officer; and Marc Becker, our CFO. We will also be joined by Nancy Stuart, our Chief Operating Officer for the Q&A portion of the call.
As a reminder, today's discussion will include forward-looking statements about our future expectations, plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10-K filed with the SEC. Any forward-looking statements speak as only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call.
With that, I would now like to turn the call over to Roger.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Thank you, Justine and good morning. As we enter 2020 Concert's achieved key milestones relating to each of our proprietary pipeline compounds that set the stage for this to be an important year for us. We have two distinct wholly owned product candidates that we're advancing toward late stage clinical testing. First is CTP-543 for alopecia areata, which we are preparing to move into Phase III testing later this year; and second is CTP-692 for schizophrenia, which is now being studied in this initial efficacy trial with potential to begin pivotal testing in 2021.
First, let me highlight our most advanced candidate CTP-543. We're conducting a dynamic clinical program from the treatment of moderate-to-severe alopecia areata that's poised to move ahead this year into pivotal evaluation. This past fall, we reported results from our Phase II dose ranging trial. The results were striking providing what we believe to be the most robust data generated to-date in any control trial for the treatment of alopecia areata. Based on these findings, and those reported state by other companies CTP-543 has the potential to be the best-in-class treatment for the slight faltering autoimmune disease.
Turning to the underlying intellectual property for CTP-543. Earlier this year, we were granted a new patent relating to CTP-543 that provides protection for pharmaceutical compositions consisting of specific dose drugs strengths and methods of treating alopecia areata with CTP-543. The issuance of this patent is significant because it covers the clinical doses that produced the robust results observed in our Phase II trial for alopecia areata and/or the doses that we expect to carry forward into our Phase III program.
The patent is Orange Book eligible on approval of CTP-543. It's expected to provide protection for 543 into 2037. We're continuing to pursue multiple avenues to secure additional patent protection for 543. And the issuance of these new patents is an important development within our broader IP strategy.
As a separate matter recently the Federal Circuit Court of Appeals granted our motion to vacate and remand Pizzettes [Phonetic] decision relating to our 149 patents. As a result, the IPR proceeding which is separate and independent from the new patents issued earlier this year will be reheard by a new panel of judges of Pizzettes. We remained highly committed to the continued advancement of CTP-543 as a potential treatment for alopecia areata and our development timelines for 543 remain on track.
Next, let me turn to the second proprietary antigen in our pipeline CTP-692, which we're initially developing as in adjunctive treatment for schizophrenia, one of the most debilitating, devastating and costly mental disorders. Schizophrenia is highly prevalent and believed to affect nearly 1% of the worldwide population. We believe that CTP-692 represents a new mechanistic approach in treatment of schizophrenia, and one that may enable effective treatment of a broader range of disease symptoms and due existing antipsychotic medications. We design CTP-692 to leverage and expand on the academic studies indicating that D-Serine can benefit patients with schizophrenia by helping to remediate NMDA hyper function, which is believed widely to be an important causative factor in schizophrenia.
Our preclinical data demonstrate that CTP-692 is differentiated from D-Serine by its dramatically improved renal safety profile. Furthermore, no evidence of renal impairment was observed in our Phase I trials. Patients with schizophrenia are reported to have low levels of D-Serine and plasma and cerebral spinal fluid. Therefore, bolstering endogenous levels of D-Serine with CTP-692 on top of their standard antipsychotic medication could offer patients a new treatment option that's fundamentally different from current antipsychotic medicines.
As a reminder, existing medicines focus on controlling dopaminergic transmission and are typically fully effective in treating so called negative symptoms and cognitive impairment, which are major reasons for patient outcomes. This program advanced rapidly from preclinical evaluation through Phase I and in December, we initiated our Phase II trial evaluating CTP-692 as an adjunctive treatment in patients with schizophrenia. The enthusiasm among the treatment community for clinical trial has been very strong. We're on track to report top-line results by year-end.
In summary, these positive developments in the ongoing execution of our business as well as in our overall strategy of designing, developing, protecting and eventually selling novel compounds with the groundbreaking potential and important diseases have led to the exciting point we've reached today with potential Phase III trials for two proprietary clinical programs in the near-term horizon.
Let me conclude my remarks by emphasizing our optimism for 2020, which we see is a year of significant milestones for our company. As we make progress toward these inflection points, I look forward to keeping you updated.
I'd like to pause here and ask Jim to discuss our clinical progress. And then, Marc will review our 2019 financial results before we open the call to questions.
James V. Cassella -- Chief Development Officer
Thanks, Roger. As Roger just described, we are well positioned to execute on the clinical development of both of our lead drug candidate CTP-543 for alopecia areata and CTP-692 for schizophrenia. We are highly focused on the need for an effective treatment for alopecia areata with a favorable safety profile, and we are continuing to advance CTP-543 to meet this product profile and bring it to the patient as quickly as possible. We are on track to meet with the FDA this quarter for in the Phase II meeting. Pending the outcome of this meeting, we expect to start Phase III program in the second half of 2020.
Putting this program into perspective, the CTP-543 results are significant for three reasons. First, we believe the data we generated in our dose ranging Phase II trials set a new benchmark for clinical efficacy and the treatment of alopecia areata. Among the JAK inhibitors being developed for the oral treatment of alopecia areata, CTP-543 now appears to have provided the most robust efficacy results reported to-date in any controlled trial.
Second, we have identified two doses of CTP-543 with promising efficacy and tolerability profiles, both of which we believe are suitable for assessment in future trials. We also see some advantages of the 12 milligrams twice daily dose group compared to the 8 milligrams twice daily dose group, including faster onset and greater magnitude of effect. Our intent is to further test and ultimately seek approval of both the 8 milligrams BID and 12 milligrams BID doses, so that patient and clinicians will have dosing options in real world use.
Third, results in our 8 milligram twice daily arm of our open label dose regimen trial were consistent with the previously reported 8 milligrams twice daily results from our Phase II dose ranging trials CTP-543. We accomplished what we set out to learn with this study and based on the results, we intend to utilize twice daily dosing of CTP-543 in our clinical development program going forward.
Additionally, we are delighted that our abstract was accepted for a late breaking presentation at AAD next month. Our presentation will expand on the previously reported results from the primary efficacy endpoints of the Phase II trial by reporting other endpoints that quantify hair regrowth of patients in the study. This is a great opportunity to further elevate the program within the medical dermatology community.
Turning now to CTP-692. Our team has moved very swiftly to progress this program. In December, we initiated our Phase II trial with CTP-692 in patients with schizophrenia. As a reminder, we are developing 692 as an adjunctive treatment for schizophrenia. Patients enrolled in a Phase II trial will be stable on their existing antipsychotic medication. We intend to randomize approximately 300 patients in the US. We're evaluating 1 grams, 2 grams and 4 grams of CTP-692 once daily compared to placebo over 12 week treatment period.
Our rationale for assessing CTP-692 is to offer an entirely new mechanism of action that treat schizophrenia it and to potentially more broadly addresses the symptoms not optimally treated with standard dopaminergic and certain antipsychotic medications. We believe that CTP-692 has the potential to improve on a primary symptom domain in schizophrenia, including positive and negative symptoms and cognitive function, when added to existing antipsychotic treatments.
In the Phase II trial, the primary outcome measure will employ the positive and negative syndrome scale, otherwise known as PANSS [Phonetic] and the primary endpoint will assess the change in total PANSS score at week 12 compared to baseline. The PANSS is a commonly used rating scale to evaluate symptoms in individuals with schizophrenia. The PANSS contains 30 items rated on a scale of one to seven. Items are divided into three symptom domains that includes positive symptoms, negative symptoms, and general psychopathology. Scores can be derived for each symptom domain and a total score can be calculated. We will also have some secondary endpoints, including the clinical global impression scale, as well as the personal and social performance scale.
For the PANSS, we will also analyse the subscales for assessment of changes specific to positive and negative symptoms, as well as items related to cognitive function. We are hopeful that by amplifying or extending the effects of the current antipsychotic agents with CTP-692, we can move -- we can more comprehensively treat schizophrenia and provide greater benefit to these patients. Top-line data from the Phase II study are expected by year end 2020. It will be a productive and exciting year on a clinical front, and we look forward to providing updates on both CTP-543 and CTP-692 as 2020 progresses.
Let me pause here, and turn the discussion to Marc to review the 2019 financial results.
Marc Becker -- Chief Financial Officer
Thank you, Jim. As I review our 2019 financial results, please reference the financial tables filed in today's press release. Research and development expenses were $59.8 million in 2019, compared to $43.1 million in 2018, an increase of $16.7 million. The increase in research and development expenses relates primarily to Phase II development of CTP-543, as well as Phase I clinical trials and manufacturing costs to support the continued development of CTP-692 into Phase II testing. General and administrative expenses were $20.3 million for 2019 compared to $22.9 million for the same period in 2018. The decrease is primarily attributable to decreases in legal and employee related expenses.
Our net loss for 2019 was $78.2 million or $3.29 per share compared to a net loss of $56 million or $2.40 per share in 2018. Finally, we ended the fourth quarter of 2019 with $106.4 million in cash, cash equivalents and investments. In January of this year, we completed a follow on offering with net proceeds of approximately $70 million. As a result, under our current operating plan, we expect our cash to fund the company into the second half of 2021.
As Roger mentioned at the start of the call, Concert has achieved several key milestones relating to our proprietary pipeline, it set the stage for 2020 to be an important year for us. Our two wholly owned product candidates CTP-543 for alopecia areata, and CTP-692 for schizophrenia are advancing toward late stage clinical testing. The ongoing execution of our business makes us optimistic for 2020, which we see is a year of significant milestones for our company.
This concludes our prepared remarks and we would be happy to address any questions.
Questions and Answers:
Operator
[Operator Instructions] Your first question comes from the line of Joon Lee from SunTrust.
Joon Lee -- SunTrust -- Analyst
Hi, guys. Thanks for taking my questions, and congratulations on all the progress. Regarding the 543, could you help us understand what the 659 patent is and the basis for being granted competition of matter patent? And for the 149 patents, what's your strategy to prevail this time around with the new panel? And how critical is it they could prevail in light of the 659 patents already giving you competition a matter of protection? And I have follow-up. Thank you.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Hi, Joon. Thanks very much for the question. So, I think your last point is really the most salient one, which is with the new patent issuance. That's really what we are seeing as an important aspect of our overall intellectual property strategy that an additional patents that we have filed and are in the process of filing will provide what we believe will be strong protection for CTP-543 to 2037 and hopefully beyond.
So, with regard to what the new patents covers, it is specifically relating to pharmaceutical compositions, that is a combination of CTP-543 and pharmaceutical recipients for dosing into humans. As the dose levels, which were the ones that related with that provided the robust results that we saw in our Phase II study. Those are, of course, the dose that we intend to take into Phase III and eventually have on our product label. And therefore, those product claims as well as the use of CTP-543, the treatment of hair loss and specifically alopecia areata would provide strong protection for 543.
With respect to the 149 patent, we don't know at this point what opportunity you will have for additional arguments around the validity of that patent. We believe that the arguments that we've made frankly should prevail as sense, but obviously, if we have an opportunity for further oral argument or any additional written arguments, we will take advantage of that.
Joon Lee -- SunTrust -- Analyst
Great. Very helpful. And for the 692 programs for schizophrenia, it seems like, there is a lot of scientific rationale for using NMDA agonists to treat schizophrenia given that antagonists are known to illicit schizophrenia like symptoms. And it looks like some of your competitors are looking at NMDA positive ballast modulators for cognitive impairments associated with Huntington's, Parkinson's and Alzheimer's diseases to this list a few. Do you have any plans for those indications as well down the road? And also, maybe can you talk about why targeting the glycine site may be a better approach than targeting the glutamate site, given that they're both coagonist. Thank you very much.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Sure. So, glutamate is more specifically related according to the literature to the potential negative outcomes of [Indecipherable] toxicity, whereas our glycine is really a coagonist site is less associated with that and as lead specifically to be deficient in terms of exposure in patients with schizophrenia. There's a fairly extensive literature indicating that both plasma levels and through the spinal fluid levels of D-Serine, which is believed to be the most important co-agonist of glutamate at the NMDA receptor are low in patients with schizophrenia.
And that's the rationale for our interest in enhancing it along with of course the initial academic studies that suggested that treatment with D-Serine itself can potentially remediate the overall symptomatology of schizophrenia including both positive symptoms, as well as other symptom domains which are not well treated by Cortex psychotic agents such as negative and cognitive domains.
As you indicated, there has been -- there remains and has been now for probably three decades a strong interest in attempting to enhance glutamatergic transmission of -- specifically through the NMDA receptor. And that has been interest that's applied not only to schizophrenia, but to other areas of cognitive dysfunction and negative symptomatology across a number of diseases. We, of course are very interested in expansion of use of CTP-692. But right now, we're very focused on trying to run a positive and statistically significant positive outcome in our schizophrenias study. And after that of course we'll work toward expanding indications.
Joon Lee -- SunTrust -- Analyst
Thank you.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Absolutely.
Operator
Your next question comes from the line of Liisa Bayko from JMP Securities.
John Walden -- JMP Securities -- Analyst
This is John Walden on for Liisa. Just a couple of quick questions for me, what are your key discussion topics at the end of Phase II meeting? And then kind of what are your thoughts you discussed two doses moving forward, but as far as endpoints duration number of patients. And where the gating factors from the end of Phase II to starting the trial?
James V. Cassella -- Chief Development Officer
Yes, sure. So, hi, this is Jim. Thanks for the question. So, this will be a -- and the Phase II means are pretty comprehensive meeting to talk not only about the specific Phase III plans, but also the whole program aimed toward registration. So, just -- so in focusing on the Phase III, obviously there are things that we need to get alignment on with the FDA including endpoint patient characteristics duration of the trial etc. We think we're in a very, very good position because of the Phase II trial that we are in, which was a definitive dose ranging trial where we've been able to identify our dose range. We identified a 4 milligram BID dose that did not work and we're not carrying forward. We identified the patient population that we're -- will be relevant for the Phase III program, and obviously our endpoint using salt as an assessment tool.
So, I think we're going into that meeting with a very solid database and evidenced to support our Phase III plans and that will be a good portion of the discussion. Once, we get agreement with the FDA on the Phase III plans and also talking in the general perspective of the program will be able to then get our study sites up and ready to go, do the logistics for supply chain for a much larger trial again for Phase III assuming that we have agreement with the FDA, we'll be talking on the order, 600 or so patients. This will be a multinational trial. We are currently working in the US and Canada, but we plan on expanding into Europe. So, there are logistics to get going for that trial. So, we are confident that we will be able to get that going in the second half of this year.
John Walden -- JMP Securities -- Analyst
Great. And then with the upcoming Baricitinib Phase III study. Can you just kind of discuss your thoughts on that program and your overall competitive positioning? Thanks.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Yeah. Thanks, John. With respect to Baricitinib, we don't have confirmation as of right now, about what doses are being tested. And there's in terms of actual clinical data that's been reported today, only a single patient who has had results in alopecia areata, and that was at a substantially higher dose and it's currently approved. So, at this point, I think what we can say is that we don't have a lot of information to go along with respect to Baricitinib other than the current product label. As you know, Baricitinib was not approved at the 4 milligram level and was approved in the US at the 2 milligram level, but with a significant black box warning associated with compound. So, it remains to be seen how the dermatology division will deal with the approval of that compound and what doses are being tested and what doses are going to be put up for approval. So, at this point, it's more of a stay tuned situation.
John Walden -- JMP Securities -- Analyst
Great. Thanks, guys.
Operator
Your next question comes from the line of Adam Walsh with Stifel.
Adam Walsh -- Stifel -- Analyst
Good morning, guys. Thanks for taking my questions. And I'll add my congrats on the progress recently. I have a couple of questions. The first one is, can you give us any granularity on the enrollment in the 692 Phase II at this point. I'm looking at your guidance for timing for that data by year end '20 and I'm just trying to get some granularity around that. Thanks.
James V. Cassella -- Chief Development Officer
Hi, Adam. This is Jim. So yeah, so, I think, it's an ongoing trial and we really can't talk specifics there. But I think I can say that, things are going as we expected, and we are still giving the guidance for data readout by the end of the year.
Adam Walsh -- Stifel -- Analyst
Okay. And then, in terms of the kind of ongoing patent litigation battle with insight, I'm just curious, are there any, can you foresee any court or PTAB decisions over the next 12 months to 18 months, can you -- and if so, can you kind of layout the timelines for when we might be getting different hearings or decisions.
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Hi, Adam. This is Roger. Thanks again for your questions. As you -- I believe you know the vacating of the order and treatment [Phonetic] of PTAB was done under the Arthrex ruling, which was unprecedented, let's say and at this point, I think we really don't have a lot of visibility in terms of how PTAB is going to be dealing with that pooling. So, it's entirely possible that it will be kicked back under the typical timelines of a one-year timeframe. But it's also possible that it'll be adjudicated more quickly than that. At this point, we just don't have anything to go on, because there's really no precedent for this situation.
Adam Walsh -- Stifel -- Analyst
And then Roger on the new patent, I'm just curious, I mean, is there kind of a historically relevant anticipated response on behalf then say what should we expect now that the new patent has been issued?
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Well, I think it's the case that of course, any patent can be challenged for any reason. We believe that we have a strong situation with that patent for a number of reasons. One of them, as I indicated on the call is that the specific dose strengths that are covered under that patent are the ones that provided a very impressive clinical results in our Phase II study. The protection of the compound is very specific to a particular composition of matter of CTP-543, as well as levels of deuterium enrichment in that compound, so it's very narrow and specific patents. And the patent was also issued by the office with full knowledge of existing litigation regarding the 149 patent. So, we think that overall it's in a very strong position to be upheld if it is challenged.
Adam Walsh -- Stifel -- Analyst
That's helpful. Roger. Thank you. And then Marc, just really quickly on the opex, can you speak to the kind of the how we should be thinking about the ramp in R&D over the next and even SG&A over the next 12 months to 18 months? I know you've given kind of the overall cash guidance, but I'm just curious, kind of sequencing it out during the 2020 quarters how we should think about the spending? Thank you.
Marc Becker -- Chief Financial Officer
Yeah. Thanks for the question. So yeah, cash will last into the second half of '21, which we mentioned earlier, and regarding build up with expense, yes, it is natural that the expense on R&D will go up now that we're into a Phase II trial for 692 and planning the Phase III trial for 543. So, expenses will ramp up, the burn rate that we're projecting for this year is approximately $90 million and it will be sequenced according to the clinical development milestones that we've laid out.
Adam Walsh -- Stifel -- Analyst
Thanks very much and congrats.
Operator
The next question comes from the line of Esther Hong from Janney.
Esther Hong -- Janney -- Analyst
Hi. Good morning. So, as Roger mentioned, the Arthrex, the Smith & Nephew ruling is relatively new. So, can you speak of any other cases earlier in the queue to patent 149 that are being reheard under that ruling and then the outcome, and when the outcomes of those cases may occur? Thanks.
James V. Cassella -- Chief Development Officer
Hi, Esther. Thanks very much for the question. I can't claim to have a lot of expertise on case law associated with Arthrex versus Smith & Nephew. Of course, Arthrex, itself is the first case to be remanded and presumably to reheard. We know that there are other cases, multiple other cases that have been also vacated and remanded. But I'm not going to try to get into the law of this because it's outside of any expertise that I claim to have.
Esther Hong -- Janney -- Analyst
Okay. Thanks. And also, congrats on the progress with all the programs.
James V. Cassella -- Chief Development Officer
Thanks very much.
Operator
Your next question comes from the line of Difei Yang with Mizuho Security.
Difei Yang -- Mizuho Security -- Analyst
Hi. Good morning, and thanks for taking my question. Just a couple, the first one is related to CTP-543. After the end of Phase II meeting with the FDA, would you expect to press release the findings or the designs or maybe holding a conference call, what should we be expecting there?
Justine Koenigsberg -- Investor Relations
Hey, Difei. It's Justine here. I guess, we would expect some form of communication to lay out our plan for our Phase III program.
Difei Yang -- Mizuho Security -- Analyst
Okay. Great. Thanks. And then follow-up on the CTP-692, so historically, we have seen clinical data of the syringe showing roughly a 10 point difference versus placebo on the PANSS score, which is a scale for the assessment of negative symptoms. How should we think about that difference in terms of the PANSS negative subscale?
James V. Cassella -- Chief Development Officer
Yeah. Hi, Difei. It's Jim. So, I think when -- we look at the literature, where there's been positive reports on multiple of the domains of positive and negative symptoms. I think that SANS [Phonetic] has been used and there's been the negative symptom factors for as well from the PANSS as well. I think what we see in this trial where there has been positive benefit is that we do see meaningful movement on both the SANS and the PANSS negative symptoms scale as well. So, I think when we designed our trial, we tried to triangulate using all the information that we had from all those positive trials to really get a sense for where we would be in terms of the individual subscales.
However, I do want to remind you that we are looking at the total symptom score, the total PANSS score. Because what that does for us, it allows us to look holistically at the patient. We know that this hearing has shown in the literature that it can move the negative symptoms, it can move the positive symptoms and improve on cognitive functions, as measured by the PANSS scale. So, we can parse those subscales out. But our focus is still on the holistic treatment of the patient by looking at the total PANSS improvement.
Difei Yang -- Mizuho Security -- Analyst
Thank you so much, Jim for the explanation. Then my final question is, how should we think about the placebo response any time we run sort of psychiatric related trials, placebo sometimes is always a concern?
James V. Cassella -- Chief Development Officer
Absolutely. Now, it's been, placebo in CNS trials is always an issue. As you know, I've been doing this for a long time. We really spent a lot of time at the investigator meeting and in design of the trial to really keep the placebo response as low as possible. We've instituted things in the trial that will keep it low as possible. We have basically a screening qualification period where we're looking for stability of the patient on hands and making sure that they are actually complying with their antipsychotic medication. We've done things to reduce the amount of time in the clinic where we know that multiple assessments things that you don't need to do can influence placebo response. So, we're very directed at getting our PANSS assessment and in the other two secondary advocacy endpoints, the PSP and the CGI.
So, I think we really built in a lot of things into the trial to really keep the placebo response under control. The other thing is that we're using very experienced sites, a lot of these sites I've worked with in the past, for my past CNS programs, you'll really spend a lot of time focused on really trying to reduce those variability that we know can lead to increased placebo response. So, I think I can say that we're really comprehensively trying to hit the placebo by multiple factors, by the way, we control the trial, by the way, we designed the trial and by the way, we are working with the sights.
Difei Yang -- Mizuho Security -- Analyst
Thank you so much, Jim, and best wishes in 2020.
James V. Cassella -- Chief Development Officer
Thank you very much.
Operator
The next question comes from the line of Robin Garner from LifeSci.
Robin Garner -- LifeSci -- Analyst
Good morning to the concert team and thank you for taking my questions. My first question is regarding the newly issued patent and I'd love to hear any further detail you can provide on the excipients that are covered under those claims and how important are they for the delivery of CTP-543 of the treatment?
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
Hi, Robin. This is Roger. Thanks very much the question. So, in principle, this covers any excipients, which enabled the delivery of CTP-543 in an old form for the treatment of alopecia areata, or for frankly, any other utilization of 543. Really what the patent is directed toward is facts that we discovered that a specific amount of a specific molecule with a specific level of deuterium incorporation has remarkable and previously unprecedented results in the treatment of the specific disease in the alopecia areata. And that specific set of both the NTT-543, the delivery of the NTT-408 for treatment of a disease state that provides the basis on which the patent was issued and the utilization of 543 going forward.
Robin Garner -- LifeSci -- Analyst
Okay. Thank you very much for that. Can you also comment, this is also regarding CTP-543 on the endpoints that are used -- being used by competitor programs in Phase III and any insights that concerts Phase II might show us in terms of being able to achieve those end points.
James V. Cassella -- Chief Development Officer
Yeah. So hi, Robin. This is Jim. So, I think the commonality that we have across all the various companies that are looking at alopecia areata is that we're all using this SALT [Phonetic] scale. So, I think that's a very important fact. And I think that provides a lot of consistency. So, in our program, we have trained and certified raters not unlike I think believe what other companies are doing. And but then it comes down to how do you look at the SALT data, and from our Phase II trial our dose ranging trial, as others have coming into the first trial with [Indecipherable] trial alopecia areata, we looked at a 50% change from baseline and call that a responder, not unlike what others have done.
And then from there, you get a slight to the data, we have very nice dose related responses and very significant results for our 8 milligrams to 12 milligram BID doses. Like the fact that we have the SALT data allows us to go in there and slice the data up in other ways because you have your basic raw data set. So, for example, we can look at the number of people who achieve an absolute SALT score of let's say SALT 20, which means that they have 80% hair coverage. So those are the kinds of things and when we look at those kinds of data, we see this same kind of consistent, beautiful, dose related responses. So, no matter how we looked at our SALT data set, we saw very significant differences depending on how you look at the slice of the data.
I think when you start looking at, for example, just clinicaltrial.gov listings, and you start seeing that companies are looking at more along the lines of the absolute SALT scores in one way or another looking at something like a 10% or 20%, hair loss, or 80%, or 90%, hair on scale. So, I think those are the kinds of things that we're thinking about that we'll be talking over with the FDA and we'll come up with that final number that we will use as our primary efficacy endpoint. But I feel very confident from the data that we have from our definitive those ranging trial that we have good data to support whatever we're going in with.
Robin Garner -- LifeSci -- Analyst
Thank you for that answer. And just my final question, is there any further information from Otsuka-Avanir on their clinical activities that they're continuing to conduct on 786?
James V. Cassella -- Chief Development Officer
So, they have not really provided any recent updates.
Robin Garner -- LifeSci -- Analyst
Okay. Thank you so much and thanks for answering my questions.
Operator
I'm showing no further questions at this time. I would now like to turn the conference back to Justine.
Justine Koenigsberg -- Investor Relations
Thank you. I would like to thank everyone for joining us this morning. Please note, we'll be participating at the Oppenheimer Healthcare Conference next month and the Wainwright London Conference in April and hope to see many of you there. This concludes today's call. Thank you.
Operator
[Operator Instructions]
Duration: 39 minutes
Call participants:
Justine Koenigsberg -- Investor Relations
Roger D. Tung -- Co-Founder, President and Chief Executive Officer
James V. Cassella -- Chief Development Officer
Marc Becker -- Chief Financial Officer
Joon Lee -- SunTrust -- Analyst
John Walden -- JMP Securities -- Analyst
Adam Walsh -- Stifel -- Analyst
Esther Hong -- Janney -- Analyst
Difei Yang -- Mizuho Security -- Analyst
Robin Garner -- LifeSci -- Analyst
