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Arena Pharmaceuticals Inc (NASDAQ:ARNA)
Q2 2020 Earnings Call
Aug 5, 2020, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, everyone, and welcome to Arena Pharmaceuticals Corporate Conference Call. [Operator Instructions]

I'll now turn the call over to Laurie Stelzer, Chief Financial Officer of Arena. Please go ahead.

Laurie Stelzer -- Executive Vice President and Chief Financial Officer

Good afternoon, everyone, and thank you for joining us today. We hope you had a chance to review the news release we issued announcing our second quarter 2020 financial results. As the quarter was relatively straightforward, and our guidance remains unchanged, we will go directly into a question-and-answer session on today's call. Joining me on the call are Amit Munshi, our President and Chief Executive Officer; and Dr. Chris Cabell, our Chief Medical Officer and Head of Research and Development. Before we begin, I would like to remind you that we'll be making forward-looking statements that involve risks and uncertainties about our goals, expectations, plans, beliefs, timing of events or future results, including those risks and uncertainties related to our pipeline, financial projections, 2020 financial guidance and the COVID-19 pandemic and its potential impact on our business. Forward-looking statements involve certain assumptions, risks and uncertainties that may be beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in our earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Arena, and we disclaim any obligation to update these forward-looking statements.

Now I will turn the call over to the operator to begin the Q&A session. Operator?

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from Alethia Young with Cantor Fitzgerald. Your line is now open.

Emma Nealon -- Cantor Fitzgerald -- Analyst

Hi, This is Emma on for Alethia. Just wondering, could you speak to why Crohn's study might be more challenging to execute in the COVID environment versus elevate? Or is kind of the uncertainty they are more related to prioritizing enrollment in UC, given the significant site overlap?

Amit D. Munshi -- Director, President and Chief Executive Officer

This is Amit. Let me take a stab at that, and Chris can add any color. It's not any more or less complicated than elevate the big differences that elevate is up and running. Whereas, the cultivate program had to get initiated. So anything that's any programs and we've said this before, any programs that are being initiated are a little bit more difficult in the COVID environment or substantially more difficult in the covered environment, in some cases, compared to programs that are already up and running in terms of sites. So I think that's sort of the short answer.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes. No comment, Amit said, exactly right.

Emma Nealon -- Cantor Fitzgerald -- Analyst

Just one follow-up. I mean this might answer that as well, but looking ahead to next year and obviously, all with the COVID caveat. But assuming success in atopic derm this year, is there a scenario where you might choose to then prioritize UEN alopecia over crones? Or are those really kind of independent of one another?

Amit D. Munshi -- Director, President and Chief Executive Officer

They're independent. We're building out we think about this in terms of franchises. We've got the GI franchise with the three indications and then the derm with the two indications. So they're all moving forward.

Emma Nealon -- Cantor Fitzgerald -- Analyst

Great, thanks.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Thank you.

Operator

Thank you. Our next question comes from Marty Auster with Credit Suisse. Your line is now open.

Marty Auster -- Credit Suisse -- Analyst

Yeah, thanks for taking the question. Amit, I'm going to give you a chance to sort of rip here. I was wondering if you could talk about the just kind of the overall of the competitive landscape in ADs kind of evolving. If you could talk a little bit about kind of where you see the unmet need. And what that competitive environment looks like for novel oral agents? And then obviously, relative to kind of when you're delivering the Phase II proof-of-concept data for etrasimod in ulcerative colitis, you're the lead player in the S1P class here in AD. So curious kind of how that has you thinking about what the bar is to have a kind of commercial successful drug going forward as we get closer to this data set?

Amit D. Munshi -- Director, President and Chief Executive Officer

Let me start with the bar question because it leads directly back into the first part of your question, which is a competitive landscape. I think it's important to just recall that every time we enter a new therapeutic area, we look at a new occasion. We do an extensive amount of work, both scientifically in terms of both the desk reserves, the animal models, but we also do a lot of work from a market environment point of view, and just understanding how the product would make a difference in for these patients. In terms of the bar, as you know, if you look at EC changes relative to placebo, they range from kind of the high teens for some of the JAK inhibitors up to the 40. So it's a pretty broad range. We think that anything in that range would be a viable commercially viable program based on the market research we've conducted. The extensive market research suggest a couple of things. One, that despite Dupi's tremendous success, seen that it has actually penetrated a relatively small percentage of the overall mono to severe atopic derm market.

And number two, there still is a wide open space for for an oral agent that has a safety profile that's substantially different from the JAK inhibitors. As I think most people are well aware, dermatologists are much more attuned to safety concerns compared to, say, gastroenterologists who are much more tuning the safety concerns compared to rheumatologists. So there's sort of a there's sort of a very interesting proposition here where a once-a-day oral that has efficacy in the range, as I discussed, and has a safety profile consistent with what we've seen historically with etrasimod. We think that's a recipe for a home run program. So in terms of patient acceptance and physician acceptance. So all of our market research suggest that if we were able to deliver efficacy data, again, in that range, that would be onto something very important in terms of a commercial program.

Marty Auster -- Credit Suisse -- Analyst

Great. Thanks, Amit.

Amit D. Munshi -- Director, President and Chief Executive Officer

Yeah. Thanks, Mark.

Operator

Thank you. Our next question comes from Yan Suneja with Guggenheim Partners. Your line is now open.

Yan Suneja -- Guggenheim Partners -- Analyst

Hey, guys. Thank you for taking my question. The first question I have is on the atopic dermatitis trial. So the trial has a 12-week treatment period and a 4-week follow-up period. So the question is, when you announce the data, will you be announcing data for the 12-week endpoint? Or will you also include data for the 16 for 16 weeks to show durability? And then I have a follow-up.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Our primary endpoint is at 12 weeks. And so this initial analysis will be focused on that. The 16-week data is really around safety. The remember, in between 12 and 16 weeks, the subjects are off study drug, and then they can enter into the open-label extension after that. So the efficacy data at week 16 is not particularly insightful. And then later on, we'll be analyzing the durability from the open-label data at a future date.

Yan Suneja -- Guggenheim Partners -- Analyst

Got it. And then in that trial, are you allowing any topical or systemic therapies? And then what happened to patients who need a rescue? And then the final question I have is on the CR formulation. When should we expect the next update? When could you actually move that into patients? Or will we see any data anytime this year or early next year?

Amit D. Munshi -- Director, President and Chief Executive Officer

Let me have Chris, take the first part, and I'll take the CR.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes. Sure. So we have strict, obviously, controls on what types of systemic and therapy is allowed. And obviously, we want to make sure that it's there's no other kind of systemic therapies that could be impacting treatment for the atopic derma therapy, it kind of depends on what that looks like. And so again, just a control there in terms of what can be effective and ensuring that there are no concomitant medications that could be impacting our ability to discern a signal. So that's the main piece there. Amit, do you want to talk about the controlled release?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. So on the CR side, we hope to be back into a series of clinical studies early next year, and we'll probably have additional data later in the year. And that's still a little bit up in the air, given that many of the Phase I sites are still closed down to the covet. So we're progressing our internal work, which has more to do with the physical formulation and ensuring that we have the CMC side of it button down. And then the we'll be heading into some additional work, again, depending on-site availability.

Yan Suneja -- Guggenheim Partners -- Analyst

Great, thank you so much.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Thanks. Yes.

Operator

Thank you. Our next question comes from Kennen MacKay with RBC Capital Markets. Your line is now open.

Analyst

Hi, This is [Technical Issues] on for Kennen. Thanks for taking all my questions. So the first question is with the atopic derma space going more crowded with multiple CEK one selective inhibitor, history data available in the first half. I think there are more better coming into the second half. So does that change any of your current strategies of each month for atopic derm? And for the upcoming fiscal readout, what should we think as a good enough data to derisk the development in the competitive space?

Amit D. Munshi -- Director, President and Chief Executive Officer

As I mentioned earlier, there's a fairly broad range of efficacy measures, again, just looking at Phase II comparing Phase II studies to Phase II studies trying to be as close to apples-to-apples as possible and looking at changing from EC from baseline compared to placebo. And we see that, again, that range from the high teens into the low 40s. So there's a really broad range. The JAK inhibitors and people talk about a crowded class what we're really seeing is just a few classes of drugs. You're seeing a group of jacks that are going to compete for one segment, probably the more severe based on our market research. Subsegment, just given the side effect profile of the JAK inhibitors, you've got the topical agents. The existing PD4s and newly emerging PD4 agents. And those are often used for mild patients in on the course of disease.

There the topicals tend to not do very well commercially as we've seen historically. And then you've got the biologics, and there you've got a couple of them in the same class being developed. So you don't think in terms of total number of therapies, you think in total number of classes, and that really is only three classes of drug. So in a market that's substantially larger than rheumatoid arthritis for ulcerative colitis in terms of moderate to severe patients, you're talking about only a few classes of drugs. And none of them afford the balance of an oral agent with the safety profile of etrasimod. If you move to the orals, you get the safety profile of the Jackson, we have a long-standing in a large database of some of the issues that the JAK inhibitors have. You're forced to move to the biologics. So for moderate-to-severe patients, there are actually very few options. And we think etrasimod fill is a very, very important part of this market.

Analyst

Thank you. So we have a follow-up question. So for the CR, which indication would you prioritize in pursuing? And would you like consider making some like new neuro inflammatory indications like MS?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. We with the specifically speaking about the CR formulation of etrasimod, is that correct?

Analyst

Yes.

Amit D. Munshi -- Director, President and Chief Executive Officer

Okay. Yes, for the initial plan with the CR is to move that into Phase III should atopic derm be successful, move it into Phase III in dermatologic indications and then bridge into the the GI indication. So that's the game plan. The newer indications, whether it's atopic derm or alopecia riot or Esinet esophagitis will all line up nicely from a timing perspective. We'll move etrasimod here in the Phase III. As far as the neuro is concerned, we've built the Arena neuroscience portfolio, and we have no intention right now taking etrasimod or etrasimod CR into any neuro indications.

Analyst

Okay, thank you.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Thank you.

Operator

Thank you. Our next question comes from Joseph Schwartz with SVB Leerink. Your line is now open.

Joseph Schwartz -- SVB Leerink -- Analyst

Thanks very much. So I wanted to ask about the dosing for etrasimod. And it's understandable why you'd have higher dosing being studied in the Crohn's trial. But I was just wondering if you could talk about the rationale to study a lower dose, the one milligram dose in the study?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. I think we did see clinical activity with the one milligram dose in the ulcerative colitis trial. So I think it's important in a Phase II study to support multiple doses. And eventually, we may need a lower dose as we head into younger populations. So with atopic derm just having a different age distribution, having lowered us there may be important over time. For this initial study, we're, of course, being adult moderate to severe atopic derm. And we're just looking for that consistency in dose response. We saw that across every measure, quantitative and qualitative in the UC study, and we'll be looking for something similar in the atopic derm study. Chris, anything else?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

No, exactly right. We're looking for dose response. And as you know, the FDA and other regulatory authorities are quite into minimally effective dose. And again, we believe the two milligrams is all going to be the most effective. I don't think that atopic derma as a place where we would go with a higher dose and the one milligram for that for the reasons that Amit mentioned is an important thing for us to understand, particularly as we think about the younger patient populations and future studies.

Joseph Schwartz -- SVB Leerink -- Analyst

Okay. That makes sense. And then as far as COVID goes, it seems like there's been some really disparate patterns of spread in different geographies. So given all of your clinical trial plans. I was just wondering if you've been evaluating the possibility to be more flexible and open up sites in areas that haven't been as hard as it essentially zigging and zagging as things evolve?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. We haven't made any changes, but that's essentially how it's worked out anyway for us. Because with UC 12 and 52, and we have a broad number of sites, approaching 400 sites in approaching 40 countries. And so the way it's really worked for us, and we did not uniformly shut the trial down at the beginning of the COVID pandemic. We turn things off on a country-by-country, side-by-side basis. So as countries came back online and sites came back online, we were sustaining first in line. And that's worked out really, really well for us in terms of continuing momentum in that study. So in a sense it's worked out exactly as you mentioned, just simply because we had a broad-ranging clinical trial. We like to think of it as sort of a rolling blackout as opposed to turning the lights off entirely. Chris, any additional color?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

That's right. And we are now making sure that we're just connecting with each and every site to understand sort of their capabilities relative to good kind of practice and ensuring that we are able to get the week 12 visits. Most of our states have a week 12 visit, and that's really, really critical. And so just really handling again more at a site-to-site level than anything else.

Joseph Schwartz -- SVB Leerink -- Analyst

Great, thanks for taking my questions.

Amit D. Munshi -- Director, President and Chief Executive Officer

Yeah. Thank you.

Operator

Thank you. Our next question comes from Jason Gerberry with Bank of America. Your line is now open.

Chi Fong -- Bank of America -- Analyst

Oh, hi, good afternoon. This is Chi on for Jason. I have some questions on Crohn's. It looks like you provide some update on the trial design for the Phase II/III. So I guess the first one is so my understanding that the endoscopic score is the primary endpoint 40 faced ongoing Phase II. It looks like Phase II for Phase III, you're planning will grow primary between the endoscopic score and the chronic score, the score. Curious your thoughts why there's a difference between the endpoint between the two programs? And then I have a couple of follow-ups after that.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

I can that. I mean for Phase III programs, obviously, there's regulatory guidance in terms of what's necessary for three Phase III level registration type of endpoint. So the co-primary of of endoscopy and CDAI is expected the SES CD and CDAI. In the Phase II study, we don't need to have that level of rigor in terms of having co primary. So we wanted to focus on endoscopy as being the most objective. CDAI, I'm looking at the sub scores in terms of abdominal pain as tool frequency, those are all important secondary components. And so we'll have all the makings of being able to analyze that data. But we really wanted to focus from a dose finding, making a decision on how we're going to handle things going into the Phase III portion of that protocol based on the most objective measurement, which is the endoscopy.

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. I'll also bring up an important point is if you look historically at other S1P modulators, they have gone into Crohn's. They have not looked at more quantitative endpoints like endoscopy and they've actually flipped that on head and looked at patient-reported outcomes only, and that's dealt some complications. So we're taking a very stringent approach here because we think that the Phase II does need to yield a quantitative directional dose-finding analysis.

Chi Fong -- Bank of America -- Analyst

Got it. And will is the CDI part of your secondary analysis for Phase II, curious if we can get a look at that as well ahead of Phase III?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes, of course.

Amit D. Munshi -- Director, President and Chief Executive Officer

That's correct. Yes and yes.

Chi Fong -- Bank of America -- Analyst

Okay. I guess you had talked about that some of the other programs are only looking at one or the other endpoints. So I'm curious, your strategy going to more stringent. I guess two part questions. There potentially be regulatory issues with some of the other programs, competitive programs that only do look at one but not both of the endpoints? And I guess my second question is, on the flip side of things, does it make it more challenging to meet the regulatory hurdle, if you choose to use the compounder endpoints?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. I think in our consultation with regulatory authorities, is probably not much different than their consultation with regulatory fees. We're talking to the same regulatory authorities. So I'm sure the feedback they're getting is, I don't want to speculate on what the agencies are saying to them to other companies that are working in Crohn's disease. We just know that the bar here is important and stringent. And we're going to take the high road here. And I've always said, and you guys have heard me say this for four years now, there are no shortcuts. So every time someone has to pull a shortcut through, it just doesn't work. The agencies are not supportive of shortcuts.

They're you can attempt to push a little bit on the agencies. But at the end of the day, doing the work is the important thing. And doing the work in a way that's that's going to stand up to scrutiny, not just from a regulatory perspective, but from a market perspective, we think is super important. And across all of our programs, the objective isn't to just satisfy a regulator, the objective is eventually to launch the product successfully and make sure we've got the data in hand, the full-body of evidence to support the payers, the physicians, the patient advocacy groups across the board. So we take a much more holistic view of our clinical programs across the board.

Chi Fong -- Bank of America -- Analyst

Got it. Maybe one last follow-up from me is that because you are pursuing a co-primary endpoint for your Phase II/III program, will you be able to use the ongoing Phase II as a pivotal? Or would you have to conduct two separate induction studies on top of a maintenance study?

Amit D. Munshi -- Director, President and Chief Executive Officer

Let Chris handle it?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes, so it's a good question. So the Phase II is going to be conducted with rigor such that if those data were definitively positive and from a co-primary analysis standpoint, it could serve as a potential pivotal. The issue is it's not powered to do that. We're looking for a dose-finding response that we can move into the phase III. So if the if we see that because they think now that is quite strong, that could be considered part of the pivotal. So it just kind of depends on the veracity of the data at the time.

Chi Fong -- Bank of America -- Analyst

Got it. Thank you.

Operator

Thank you. Our next question comes from Jim Birchenough with Wells Fargo Securities. Your line is now open.

Nicholas Abbott -- Wells Fargo Securities -- Analyst

Yes, hello. It's Nick for Jim for this afternoon. First question on olorinab. The primary endpoint for the Phase II trial is this pain score. Is that a validated scoring system? And could it be used to support product registration in a Phase III?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. First of all, thank you for asking about olorinab. We're incredibly excited about the program, and we think there's tremendous unmet medical need. The Phase II study, and I'll provide all the right cats here, the Phase III study was a small open-label exploratory trials. So I want to caveat any time we talk about that trial. It was really designed for us to make a go no-go decision to move to Phase IIIb. We did use a validated endpoint. The AAPS 10-point scale, the average abdominal pain score is a validated instrument. It's the instrument that's been used in multiple other agents in the IBS area to facilitate approvals. So there's a validated endpoint. It does read-through from Phase II to we'll read-through from our Phase IIb into our Phase III study.

Nicholas Abbott -- Wells Fargo Securities -- Analyst

Great. And then in terms of patient enrollment, is that balance between IBS-C and IBS-D to allow for certain analysis of those patients?

Amit D. Munshi -- Director, President and Chief Executive Officer

The study is empowered for separate analysis. So the initial top line data will be a pool read between those two groups over time as we move toward getting the data out there at major medical meetings will be providing additional color on different subsets of patients.

Nicholas Abbott -- Wells Fargo Securities -- Analyst

Okay. And then given tid dosing, is this product a minimal to a controlled release formulation?

Amit D. Munshi -- Director, President and Chief Executive Officer

It might be. We did a lot of work again before we moved forward with the program. And we asked is tid commercially viable is, should we to less frequent dosing. And in terms of out in the pain setting, the frequency of dosing is much less important. So if you just think about very simple analogs, like you ask yourself is more ibuprofen sold or is more than a proximate sold for over-the-counter pain, and you'll see it's ibuprofen at qid versus once-a-day naproxen. And so in the pain saying, it turns out to be a little less important. It does it's probably less of a CR and more of an XR formulation, that would eventually get us to less frequent dosing. But right now, the market resource doesn't really support that broadly. So on the back of the Phase II data, those will be conversations we'll have internally.

Nicholas Abbott -- Wells Fargo Securities -- Analyst

Great, thank you very much.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Thank you.

Operator

Thank you. Our next question comes from Roger Song with Jefferies. Your line is now open.

Roger Song -- Jefferies -- Analyst

Thank you for taking the question. Maybe I have two questions, maybe just one. The first one is adding additional question for AD. So we saw a couple of kind of pivotal data readouts from the JAK inhibitor and very interesting, some of them are showing some anti IgE benefit. I'm just curious what you kind of measure this endpoint moving forward. Additionally, kind of magnetically, how do you believe kind of a trial model can address that pathophysiology?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes. So let me hand off to Chris.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

I mean, itch or pruritus is a super important part of understanding what's happening from atopic derm perspective. It's not part of the clinical endpoint is important for registration. But at the patient level, it's very important. And so something that we're going to be looking at quite carefully. And we do believe that from a mechanistic standpoint, when you look at impact on dendritic cells and then also the entire T2 access that trials could play nicely into that. Obviously, the data are going to be the data and we'll see what they look like when they come through here later in the year.

Roger Song -- Jefferies -- Analyst

Got it. I just clarify, you will have that endpoint for the Phase II?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes. Part of the second endpoint.

Roger Song -- Jefferies -- Analyst

Awesome. Great. Another question, I think, I mean, you mentioned a little bit, but I just want to kind of clarify. So in terms of the control release formulation, can you just elaborate on the operational steps in order to get to the first clinical study?

Amit D. Munshi -- Director, President and Chief Executive Officer

Yes, absolutely. So as you know, we've already conducted one set of clinical experiments, looking at PK/PD, and the next step is to move to a solid dose formulation, and we'll be exploring multiple solid dose formulation. As I mentioned before, COVID-19 dependent, we'll be able to move into some additional clinical work. To validate that what we do in the first study, we can now see what the second step, which is the solid dose formulation. So a lot of work right now on the CMC side. And then as soon as we have that, we can begin to do the bridging work we need to bridge directly into the Phase III programs, assuming the derm indications and EoE are successful. So it's really heavy lifting on the CMC side on the front end. And then some early clinical work that has to get done and then finally some bridging work that gets us there. So it's you don't have to go back and replicate the Phase II programs. It's just a bridging work that has to get done, both from a human perspective as well as from an animal tox perspective. And all of that is in the plan and in the budget.

Roger Song -- Jefferies -- Analyst

Great, thank you. Yeah. That's all from me with congrats.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Great, thank you.

Operator

Thank you. And our next question comes from Patrick Trucchio with H.C. Wainwright. Your line is now open.

Patrick Trucchio -- H.C. Wainwright -- Analyst

Thanks, good afternoon. I have a follow-up on etrasimod in atopic derm. So first, how soon following the advise outcome, could you hold an end of Phase II meeting with the FDA? And could the COVID-19 pandemic have an impact on this timing? And then secondly, is it your expectation that a potential pivotal program we do include both pediatric and adult patients from the start? Or is there some reason you would move forward in one patient group versus the other initially?

Amit D. Munshi -- Director, President and Chief Executive Officer

So let me handle the Phase II, and then Chris can talk about the pivotal program. We haven't disclosed a lot of details on the pivotal program. So we want to be a bit cautious there. End of Phase II, we'll move as fast as we can move humanly internal to the company. And then the rest is up to the agency. We haven't seen substantial regulatory delays in getting to Type C meetings with the agency. So there's no reason at this point to believe that it would be any different in the COVID environment as opposed to the pre COVID environment. So we've got teams already working. We do a lot of prep work ahead of the Phase II data, so we can move as quickly as we can, quickly as possible, really on the back of the on the back of Phase II data. Do you want to talk about the COVID?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

As Amit mentioned, we haven't disclosed much about the overall plans for that pivotal trial. As you know, from us to the competitive products, they're often looking at adolescents, so ages 12 and older as well as adults. So that's something we'll have to consider. We have an overall pediatric plan that we're moving forward with the UC program. And that interaction with the regulatory agency will influence kind of how we think about other patient populations. So we'll be making those decisions as we come out of the Phase IIb data readout later this year.

Patrick Trucchio -- H.C. Wainwright -- Analyst

That's helpful. And then just a follow-up on etrasimod in EoE. I'm wondering if you could well, first, if you can just comment on what is it that you need to see with the COVID-19 situation, that would enable this trial to move ahead on time? Or what would happen there that would make it not move forward? And then can you discuss the expected EoE study and how FDA guidance issued in 2019, including preference or clinical outcome assessments and histologic response, et cetera? How this is impacting the design of the trial? And then finally, what questions could you be looking to answer in the study?

Amit D. Munshi -- Director, President and Chief Executive Officer

Okay. So let me hand off to Chris to go through that.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Sure. Yes, no problem. In terms of starting the study, there's nothing about COVID-19, in particular, related to EoE, that's a problem. It's what Amit mentioned earlier in the call, which is all about initiating studies. And it's really a site level issue about IRBs are willing to take on a new study during this time, impact on health systems, that type of thing. So we're proceeding as planned. So far, the reception has been strong and have already site quite interested, but it's just really dependent on on actual clinic hospitals and healthcare systems and their ability to take on new research during the epidemic, pandemic. The second question, in terms of the FDA guidance, it's a really interesting question that we've been working through. Because there's a lot of, I guess, I would say, lack of alignment among EoE experts and some of the work that's being done by and other competitive products in the FDA in terms of that guidance document.

So we enter into very close discussions with the FDA to get their feedback on our programs across all programs and then to make sure that the design of our Phase II studies are going to be adequate to be able to give us information, that will allow us to have a successful end of Phase II meeting moving into Phase III. And so we so that's just a split of philosophy of the company that we make sure that we interact with the FDA prior to commencing those types of studies to ensure that we are in alignment with their current thinking but sometimes isn't reflected in the guidance documents that are released in previous years. So EoE is a pretty dynamic situation right now because of the intense interest in the disease that's really now just becoming something that is routinely well, not even routinely, but is becoming more commonly diagnosed. So it's a very dynamic development area. And then your third question, I'm sorry, I'm blanking on the third part of that question.

Patrick Trucchio -- H.C. Wainwright -- Analyst

Just in terms of what questions could you be looking to answer in the study?

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Yes. So we'll be looking, obviously, at two kind of main components. So one is patient symptoms and the other is going to be data that we get from biopsies to understand the impact of etrasimod relative to the kinds of things that are going to be important in terms of eosinophilic reduction within tissues as well as patient symptoms. So it's those two kind of broad areas that we'll be focusing on. We have a belief that eosinophils in themselves are maybe not the most important thing. So we'll be looking at a broad array of other kind of pharmacodynamic measurements, including cytokines and cell types and that type of thing to give us some insight into etrasimod's mechanism of action relative to this particular disease. And obviously, we've done some animal work and things, but that to give us a pretty good sense that we're going down the right path here and the trial data to use critical there.

Patrick Trucchio -- H.C. Wainwright -- Analyst

That's helpful. Thank you.

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Thanks.

Operator

Thank you. And I'm showing no further questions in the queue at this time. I'd like to turn the call back to the speakers for any closing remarks.

Amit D. Munshi -- Director, President and Chief Executive Officer

Great. Thank you. Thanks, everyone, for joining us today. As you can see, we remain highly focused on clinical trial execution, maintaining data integrity at the highest levels. In progressing our key programs, all while managing our time lines and spend. We, as are all the other companies, are consistently monitoring the potential impacts of COVID-19, and we'll provide updates as needed. I'd like to just take a moment here to thank the investors and the analysts for ongoing support and really the entire Arena team for the tremendous work to maintain strong momentum during these difficult times. We look forward to updating you on our progress, and we continue to execute on key milestones. And importantly, we look forward to top line Phase II data for etrasimod in atopic derm in Q4 of this year and for olorinab in abdominal pain associated with IBS early in the new year. So with that, everyone stay safe and take care and look forward to our next conversation. Thank you.

Operator

[Operator Closing Remarks]

Duration: 37 minutes

Call participants:

Laurie Stelzer -- Executive Vice President and Chief Financial Officer

Amit D. Munshi -- Director, President and Chief Executive Officer

Chris Cabell -- Executive Vice President, Head of Research and Development, and Chief Medical

Emma Nealon -- Cantor Fitzgerald -- Analyst

Marty Auster -- Credit Suisse -- Analyst

Yan Suneja -- Guggenheim Partners -- Analyst

Analyst

Joseph Schwartz -- SVB Leerink -- Analyst

Chi Fong -- Bank of America -- Analyst

Nicholas Abbott -- Wells Fargo Securities -- Analyst

Roger Song -- Jefferies -- Analyst

Patrick Trucchio -- H.C. Wainwright -- Analyst

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