Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Stephanie Lee. Please go ahead.
Good morning, and thanks for joining today's call to review the CLARITY phase III results. I'm Stephanie Lee with Roivant. Presenting today, we have Matt Gline, CEO of Roivant. For those dialing in via conference call, you can find the slides being presented today, as well as the press release announcing these updates on our IR website at www.investor.roivant.com. We'll also be providing the current slide numbers as we present them to you all along. I'd like to remind you that we will be making certain forward-looking statements during today's presentation. We strongly encourage you to review the information that we have filed with the SEC for more information regarding these forward-looking statements and related risks and uncertainties. With that, I'll turn it over to Matt.
Thank you, Steph. Thank you everybody for joining this morning on short notice. We really appreciate it. It's obviously an exciting moment to get together. I'm going to do a little bit of frame-up here, then I'm going to take you through what are some obviously really exciting data that we're putting out this morning. Starting on slide three, just as a reminder, this was from our Investor Day last year. By the way, we're announcing today that we're doing another Investor Day in December of this year. We'll come back to more of that in a moment. But it's the middle or early innings of a really busy period for us.
We're excited about continuing to add green check marks to this slide such as it is as we advance multiple among these programs, but just wanted to highlight lots more to come, including LPP, CS, other representative indications, and well beyond. Just a tremendously exciting moment. As a reminder on slide four, our overall hypothesis around Brepo was always that we could find a constellation of diseases where there was a sort of orphan prevalence with a large unmet need with pathobiology specifically aligned to the unique mechanism of Brepo, and where we thought we could make a big difference. I think DM was obviously the first proof point for that, and now LISRAYA is out in the market. By the way, one comment. We're not going to be talking today about the LISRAYA launch.
We are excited to do that on our Q on November 9th with our quarterly earnings. Today we are focused on the NIU data. With NIU, we have added another leg to that stool such as it is, another proof point which hopefully will become a commercial product here that we can deliver this kind of transformative data and these high morbidity indications. There is a lot of need. On slide five, NIU is a high morbidity indication. It is the third leading cause of blindness in the U.S. There is not a lot that works here. The only really approved non-steroid therapy is HUMIRA. Both in the clinical data as well if you look at the claims data, it looks like half of NIU patients on HUMIRA either fail or worsen while they are on the drug.
There is a high unmet need, and you can wind up in addition to blindness, obviously wind up with pain, with redness, with distorted vision, with floaters, headaches, fatigue, just a really tough disease. It is a fairly prevalent disease as well. Obviously, many of these patients have front-of-the-eye inflammation. Even among patients with back-of-the-eye or all-over inflammation, there are somewhere between 70,000 and 190,000 of those patients from a variety of different etiologies. It is just an indication with a huge amount of unmet need in the world. One highlight on slide six, and we are going to talk much more about the marketplace for NIU, how it is evolving, how we see the patient numbers, et cetera, on our Investor Day in December.
In the meantime, just as a reminder, we are in a moment of evolution for the treatment of NIU across a couple of different axes. First, over time, more and more of these patients are getting treated by uveitis specialists, often at uveitis referral centers. These are docs with either a specific uveitis fellowship under their belt or they are double-boarded or whatever. These are docs who are really specific to treating these patients and who are highly comfortable with systemic therapy. Often they have a general medicine training as well and away from these community retina docs who are more procedure-based in their approach.
Part of that is coming with an increasing understanding that this systemic, this local sawtooth flare and treat cycle, which the localized therapy and high-dose steroids lends itself to, is just not good for patients or their eyes. There is a goal to get much more stable, long-term, properly controlled disease. Bluntly, given the quality of data we are putting out today, Brepo could not have come at a better moment for that transition. We are excited to talk more about that. I think as you speak, especially these uveitis specialists in your own research, you will hear something similar reflected back to you from the field. With that I am going to get into data. Ben Zimmer from Priovant on the call, too.
I am going to present the data, but he will be available for Q&A as we get into it. Look, on slide eight, before we get to the headline, just a reminder, we chose NIU on a pretty directed thesis that it is understood that a number of the key pathogenic cytokines involved in NIU, IL-23, interferon gamma, IL-12, IL-6, all of these are signaled by either JAK1 or TYK2, and that Brepo will therefore get us good inhibition across this whole inflammatory cascade. That was the hope. Obviously, the NEPTUNE phase II data was highly suggestive, albeit with small n.
I think, look, the headline here, and we will get into it now on slide 9, is I would say largely, we recapitulated the really, really exciting data that we had seen in NEPTUNE in phase II in much larger n, and we introduced a placebo arm that looked comparable to what the placebo arm in other studies, including the HUMIRA study, showed. Just a really great outcome. We got the largest efficacy benefit ever seen for a non-steroidal therapy. Our time to treatment failure was the primary endpoint here, was over 48 weeks. It was a 48-week study. We will go into the study design. More than half of the patients had not yet failed by the end of the study, so the median time to treatment failure was in some sense indeterminant or not reached by 48 weeks versus about 12 weeks.
12 weeks in one of the studies and 13 weeks in the other study, with obviously a really great P value. We met the primary endpoint and every secondary endpoint in each study on a separate basis as well as on a pooled basis. We had over 60% of patients got to steroid-free quiescence. That is a steroid-free quiet eye at the end of the study, which is really a key treatment goal for physicians. It is something that docs are really working towards. It was consistent across all subgroups. We had statistically and clinically meaningful improvement in vision-related endpoints, structural and functional benefits, including on fluorescein angiography. Really great resolution of macular edema. We will talk more about that. Just a phenomenal outcome.
A safety profile, which we will go into, but which is well-tolerated and entirely consistent with everything you would expect, both from our own prior data and from the JAK inhibitor class and other JAK inhibitors. On slide 10, as a reminder of the study design here. This was an event-based study. It was a 48-week treatment period. CLARITY-1 and CLARITY-2 were identical studies. You can see all the ends on the slide. The way these studies work is you start out with a very high-dose burst of steroids, 60 mg starting for two weeks, and then you taper. As a reminder, we had, I think, the most aggressive steroid taper, certainly in any big NIU study. We were tapering over six weeks as these patients were fully tapered by week eight.
Our data is particularly exciting in the context of having achieved it, even against the backdrop of a more aggressive taper than in the other studies for approved drugs. That is sort of the design of the study. Then these patients, once they failed treatment along a variety of different axes, they were then taken out of the study and put into an open-label extension. Or a long-term extension, I should say. So that is the design of the trial. This was a representative NIU population on slide 11. Good range of patients, good disease severity. Notably, about a third of the patients across the studies were exposed to prior TNF. That is really nice to have that data set, and we will talk more about what it looked like in that group specifically.
Obviously, this is one of the first studies where that specific population could have been evaluated, and so exciting to see that. But overall, a severe sort of high rate of macular edema in the patient population. A good group of patients for the study. We were happy with how that shook out. I will not go into them all here, but on slide 12, just again, we had really terrific P values in both studies on the primary and on every secondary endpoint, and that is across a variety of both functional, patient-reported, et cetera. So a variety of outcomes. On slide 13, most of our trials thus far have not been event-based studies, so we have not had a lot of opportunity to put out Kaplan-Meier curves. These are, from our perspective, just absolutely beautiful curves from a variety of different axes.
One, just in absolute terms, you look at these patients, the rates of treatment failure, again, placebo, 12 and 13 weeks, depending on which study. In both studies, Brepo did not hit 50% treatment failure by the end. But also frankly, just like the flatness of this curve in the back half of it, not only are we not hitting 50%, but it really looks like these patients are stable leaving the study, which is a phenomenal outcome given the quality of the treatment effect. Notably on slide 14, on the left-hand side here, you have the pooled Kaplan-Meier curve for both CLARITY-1 and CLARITY-2. On the right-hand side, you have the equivalent curve from the VISUAL I from the HUMIRA study. Obviously, a cross-trial comparison with all the appropriate caveats. Obviously, on the right-hand side in VISUAL, a less aggressive steroid taper.
But overall, I think it highlights in pretty sharp relief that this is field-changing, that this is a really different qualitative option for these patients that will, we hope, help a lot of people. On slide 15, this is another version of effectively the same cross-trial comparison. I just want to highlight, not only did we blow it out of the water in terms of time to treatment failure, but because we did it against a more aggressive steroid taper, the overall time from the end of steroid dosing to the median treatment failure is even more exaggerated to our favor in a way that feels really great. These patients are getting long, durable responses, or long, durable stability, I should say, without being on background steroids, which is just awesome for this patient population.
Then to go through a couple of the subgroups and secondaries now, starting on page 16. This is a comparison on the left-hand side of the pooled data in the overall population for the treatment failure rate at the end of the study. You can see, again, 33.5% on Brepo, 78% on placebo. On the right-hand side, we have the data specifically in the subset that had prior TNF experience. This is data that has already been pretty head-turning in the community of docs here, and it looks pretty similar, to be honest. We are able to deliver a highly comparable rate of treatment failure on drug for the TNF failure patients as in the overall population, which feels really good.
I mentioned on slide 17 this change in paradigm where we are going away from sort of sawtooth flare cycle treatment to trying to get this sustained steroid-free quiescence, trying to get these patients to a stable place. You are going to see a quote here from an important doc in the field. I think that change is particularly good for us in this moment because of what we have been able to show. On slide 18, this has been another really well-received early with activated data point. We are getting very high rates of steroid-free quiescence at the end of the study up to close to 60% or above 60% in one of the studies versus about 20% on placebo. A very high proportion of these patients are stable with quiet eye, and I think notably, this is quite a strict definition for steroid-free quiescence.
If you show this definition to docs who treat these patients, this is a really good bar to have hit, and we cleared it very comfortably. I am not going to go into a lot of great detail about what this is, but docs now manage these. Obviously, treatment failure is a very clinical trial endpoint. It is not something that docs are thinking about on a day-to-day basis. A lot of these docs use fluorescein angiography as a technique to monitor and manage these patients. We have an endpoint in the study, it is on slide 19, defined where we had a scale using fluorescein angiography to evaluate these patients. That is notable again because it is a lot of how these patients are managed in the field. On slide 20, you can see as a matter of separation from placebo, this again is in the pool of data.
Just tremendous separation from placebo on this measure, which again is something that I think docs are going to find really valuable because it foots much more closely with a relatively rigorous benchmark against which how they manage their own patients. A couple more data points here to share. Again, we are just excited about the totality of it here, so we are putting a lot out there. One on slide 21, macular edema. We said about a third of the population, I think, came in with macular edema. The exact numbers are in the earlier slide. Of those patients, 40% of them in CLARITY-1 and a little bit more than that in CLARITY-2 saw resolution, a clinically meaningful resolution of their macular edema by the end of the study, compared with very low rates on placebo.
This is something that generally you don't achieve with systemic therapy in other studies. The fact that we were able to get quite high rates of resolution of macular edema, again, very exciting here and another way in which Brepo has the potential to be important for this patient population. Lastly, from an efficacy perspective on slide 22, there's a variety of different ways of measuring efficacy from a functional perspective, and frankly, everything we studied looked good. This is one of the secondaries. This is a visual function questionnaire. This is a patient-reported outcome with a bunch of sub-scales including general vision, pain, near activities, distance activities, mental health, difficulty with role, dependency, and driving. We saw, starting with week six, meaningful separation with very good benefit for Brepo 45 relative to placebo in both studies.
Not only delivering sort of the kind of things that ophthalmologists care about managing the disease, but the kind of thing that patients care about in living with the disease, which feels really, really good. The truth on slides 23 and 24 on safety is not much new to report. Consistently well-tolerated and consistent with prior Brepo studies and with the JAK class. We lay out the rates of AEs on 23 in a little bit of detail on slide 24. Happy to take questions as they come up, but our overall view of this is it's consistent with the label on LISRAYA already and consistent with what people will expect for the drug. To summarize the data on slide 25, just a really terrific outcome. We could not be happier here.
The steroid-free quiescence sets us up for the sort of present and future of treatment of NIU. The imaging biomarkers will appeal to docs who use those techniques to manage these patients on a daily basis. We're preserving acuity and function, and we have safety that is consistent with JAKs and certainly in our view, a good trade-off for benefit for patients with a disease that can lead to very bad morbidity in the eye. Remember, many of these patients are otherwise on quite high doses of background steroids, which are not safe or well-tolerated over long periods of time. Against that backdrop, just a really nice finding. The Priovant team is going to get this sNDA in in the first half of 2027. Hopefully between everything, that'll lead to a relatively quick approval.
Taking a step back before we head out and open the line for Q&A on 26. We've said all along that we are just getting started with Brepo, and we're starting to sort of climb this hill or build this wall one brick at a time. NIU obviously now hopefully the second registrational indication. We got two more already in the pipeline with CS and LPP, both well underway, enrolling patients, looking promising from that perspective. We have a ton more we want to do, and I know Ben and the Priovant team are raring to go getting additional studies up and running. We think this just has the potential to be a huge opportunity across lots of diseases where consistently very high unmet need and not a lot of other options for these patients. Excuse me.
As a reminder on slide 27, this is just one of multiple among our programs. Now with mosliciguat in pivotal studies after the great data we had earlier this fall, IMVT-1402 with a huge year next year with data coming in MG and Graves and a number of other studies ongoing as well. Still to come this year with further updates on the phase II of the difficult-to-treat rheumatoid arthritis study, another really exciting indication for us with a high unmet need. Lastly, on slide 28, on December 9th, we will have our annual Investor Day or our Investor Day this year anyway in New York City. Looking forward to seeing many of you there.
One of the things we will definitely do is talk more about the NIU market and get into what we see as the opportunity and the unmet need for patients in clear relief. Frankly, I think this is an area that has been understudied by our investors over the last, call it, 12 months as people have been more focused on the present commercial launch in DM. As a reminder, as we get to Q&A, we are not going to take questions on the LISRAYA launch today.
We are looking forward to taking them and talking more about how that is going, which we are very excited about on the Q in November. That is it for the presentation today. Before we head out to Q&A, I just want to say thank you to a bunch of people here. Obviously, most importantly, to the investigators and patients who have trusted us.
Thank you. We would not have this science without you, and obviously, it is an interesting thing to give yourself over to a clinical trial. We are happy, in this case, to have been able to make it worthwhile. Secondly, I want to thank Ben and the Priovant team, who did a phenomenal job again with this study. I am really proud of the quality of clinical execution that Roivant has been putting up here, and this is another example of an indication where I think first pioneered by Roivant on the investments of the governance team, by Dr. Frank and everybody at the Roivant side, and then put into a phase II study, then a phase III study. It is just nice to continue to see this execution. So I want to thank the Priovant team, the Roivant team, just a huge effort. So thank you, everybody.
With that, I want to say thank you all for listening, and I will turn the call over to Q&A.
Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. As a reminder, in the consideration of time, please limit yourself to one question and one follow-up. One moment for our first question. Now, first question in queue coming from the line of Yaron Werber with TD Cowen. Your line is now open.
Good morning. Congrats team, and congrats on a really fantastic data set. My question is the data is so clear pretty much all across the board, whether you look at TNFs experience, you look at macular edema, oral, very well tolerated, very fast onset of action, and obviously very good durability. HUMIRA is cheaper. Do you think you will need to go through a HUMIRA step- edit ? I assume you will get a broad label. Is there a chance you can get used before HUMIRA? Thank you.
Yeah, thanks, Yaron. Look, thank you also for the commercial on our own data. We agree with everything you just said about it. It is really great data. I appreciate the question. Look, I think the truth is we obviously do not know the answer to that question. Our data is really, really strong. HUMIRA has some real liabilities in this area. So there is certainly a chance that the docs will be excited about the data and will want to use it earlier. I think that opportunity exists. As a reminder, in general, the FDA stance on JAK inhibitors is in a TNF-approved indication. There is some labeling that suggests the use of a TNF first. I think your payer point is reasonable, although there are plenty of plans where more expensive therapies are allowed without first stepping through HUMIRA in indications where HUMIRA is approved.
There are certainly examples where earlier line therapy is possible. I think the only thing I will say is there are, I think we put out a number for like 37-ish thousand at least NI or sorry, yeah, NIU patients on TNFs. Even the TNF failure population or the population of people who could be better controlled despite use of a TNF is a large and exciting opportunity and one where there is a lot of unmet need. I think we certainly have an opportunity to go earlier, but also I think we do not need to. Thanks, Yaron.
Thank you. Our next question coming from the line of Brian Cheng with JP Morgan. Your line is now open.
Hey, guys. Thanks for taking our questions and congrats on the data this morning. When we look at the treatment failure, I believe there are three criteria that goes into defining treatment failure. I am curious how the responder is seeing how that breaks down, compared to HUMIRA treatment failure. Is what we are seeing driven by specific components? Second, can you frame how we should think about the resolution in macular edema, this piece? Do you expect that benefit to be on the label? Just curious how important that is from a commercial perspective. Thanks, guys.
Yeah. Thanks. On the first question, I can say there are four criteria for treatment failure. There are new vascular lesions, a change in ACC or VH grade or BCVA worsening. I feel like overall across the population, treatment failure was driven by all of the different components. There was nothing that stood out specifically. It was pretty well balanced. Ben, do you want to take the macular edema question short?
Yeah, sure. I think we will TBD what [inaudible] will get on the label. I think that it is an exciting add-on and differentiation, particularly from adalimumab or any off-label other TNF inhibitors or biologics that are used. As Matt mentioned before, it is generally both from clinical trial data and clinical experience, the view that these patients are not able to address their macular edema through those therapies. I think what is really exciting about this data overall is the opportunity to combine benefit on macular edema and CST with a therapy that could provide overall sustained disease control around inflammation and uveitis more broadly. I think it will be an exciting point of differentiation in the context of the overall data set, but I think that there is a lot here that is going to be really exciting to doctors.
Thanks, Brian.
Thank you. Our next question is coming from the line of Yasmeen Rahimi with Piper Sandler. Your line is now open.
Team, congrats to the outstanding data. Team, it would be wonderful if you could educate us. I think you did a great job with Brepo and DM on helping us understand that these patients are in concentrated centers. Maybe just talk about sort of the heterogeneity or is there a cluster of these patients under these community retinal docs? How do you envision that? To the extent you could talk about how much that would involve expansion of your sales force that would be dedicated to the NIU launch. I know maybe many of these things may come up at the R&D day in December, but to the extent you could give us some broad color, we would be very grateful.
Great. Thanks, Yasmeen. Appreciate it. It is a good question, and we will hit a lot of this in more detail on our Investor Day in December. I think, first of all, there is just an increasing trend towards more of these patients being treated at these centers. I think the centers make excellent early relationship points for us here because they are equipped to manage systemic medicine and are already big users of systemic medicine.
We will talk a little more about number in the future, but I think they will be among our earliest and most important call points. There are obviously also retina docs and docs in the community who partner with rheumatologists and so on to use systemic medicine, and you can see where they are. They use HUMIRA and so on. I think we are going to be able to call on a variety of different physicians.
I'll say, I think the correct expectation here is this is a different commercial organization than the one largely currently launching in dermatomyositis. I think it's going to be a new commercial effort. Obviously, the patient support work, a lot of the other things that are going into making the LISRAYA launch successful will be reusable, but the field personnel will be different. Look, I think the truth is these patients are often going blind. They're not hard to find, right? They're out there. They're engaged with their docs, and the doc tolerance in general for eye disease is poor, for eye inflammation is poor. Docs are reaching for the most aggressive things they can find, and so they are tens of thousands of these patients are treated in these specialty centers.
More and more are getting referred there, and I think the goal is to treat them very aggressively. Thanks, Yasmeen.
Thank you.
Thank you. Our next question coming from the line of Samantha Semenkow with Citi. Your line is now open.
Hi. Good morning. Thanks very much for taking the question, and congratulations on this really great data set. I am wondering if you could talk a little bit more about your appetite for potentially expanding indications for Brepo, specifically within ophthalmology. Maybe even for diseases with macular edema, given the data this morning, relative to the expansion opportunities for other therapeutic areas, because I know that there is potentially a long list that you are evaluating. Thanks very much.
Yeah, thanks. It is a great question. Look, I think the short answer to our appetite for expanding indications for Brepo is high. We are doing a lot of work on that. There are ophthalmology indications on our list. There are other indications on our list. I am not prepared sitting here today to commit to any particular sequencing or path of those, but I will say we are living with this data fresh. We have only had it for a few days. So let us continue to study it and see what avenues it suggests. But lots of great places to go. We are spoiled for choice, and definitely hoping to do more fast. Thanks, Sam.
Thank you. Our next question coming from the line of Alex Thompson with Stifel. Your line is now open.
Hey, great. Thanks for taking our question and congrats as well on the data. I guess one of the other differences versus VISUAL I was that you did not require patients with baseline OCS use. I guess, could you comment on sort of how those patients did and maybe to Yaron's question earlier, sort of what that might mean for how Brepo could be positioned within the broader NIU population? Thank you.
Yeah, thanks. It's a great question. I appreciate it. Ben, I'll ask you to comment too. Look, I think in general, first of all, it's a severe patient population. We had similar efficacy regardless of whether baseline OCS were involved or not. Obviously, a unique thing about this patient population is that there are also TNF-experienced patients in it. There's some pretty sick patients who've gone through a lot of things. Obviously, for example, the VISUAL studies obviously couldn't have included TNF refractory patients, so we wanted a broad population. I think that will be helpful in the sense that it opens up the broadest possible opportunity for NIU patients, sort of regardless of where they are in the treatment cascade. Again, no sort of significant differences in effect across those subgroups. Ben, anything you'd add to that?
No, I would just say that the VISUAL study was conducted a while ago. I think there are more heterogeneous therapies used today to control patients with active disease, including systemic therapies, obviously TNF inhibitors which were not used at that time being the major other off-label therapies, DMARDs. What we really wanted was a population that matched the real-world population, and I think that's what we got, which includes a lot of patients who were on background steroids, some who had been on in the past but weren't at the moment, patients who'd been on other therapies.
Yeah, that's what the baseline criteria or the baseline demographics I think capture well across a variety of ways in terms of percent of patients with macular edema, percent of patients with posterior and pan-uveitis, percent of patients who had prior TNF therapy, I think captures this broad-based active population, and I think that's really kind of where we would expect to see the drug used in the real world as well.
Thanks, Alex.
Thank you. Our next question coming from the line of Yatin Suneja with Guggenheim Securities. Your line is now open.
Hey guys, thank you for taking my question and congrats, obviously, on the data and continued amazing execution. Just a question on the payer front. What sort of feedback you have received or the work that you have done, especially now that we know what the price is going to be? Again, I think it's a similar type of a question that Yaron asked earlier, how should we think about positioning and the acceptability of the price in the context of what is out there for these patients? Thank you.
Yeah. Thanks. Look, it's a great question. Obviously, it's early days, even in the LISRAYA launch, so I think we're happy with how things are going so far, but still learning how to manage that over time. But again, happy with how things are going so far. Also quite early days with this data. So I think it's a little bit premature to answer that question. The unmet need is very high here. These patients are losing vision. There's very high morbidity from the disease. We've seen in other markets tolerance for high price points in eye disease, frankly, because the unmet need is high and because the ability to improve morbidity for these diseases really matters. I'll say, as a reminder, dosing here is 45 mg, which is different from the DM dose. So we have some flexibility on price in terms of where we could go.
I think, I'd say every option is open. We haven't made any decisions. Again, we have only had the data for a few days. So looking forward to learning more from exactly the conversations you're suggesting over the next month. I think we got a lot of flexibility in a disease with very high unmet need.
Thank you.
Thank you. Our next question, coming from the line of Prakhar Agrawal with Cantor Fitzgerald. Your line is now open.
Hi. Thank you for taking my questions, and congrats as well from my side on the data. Maybe, Matt, you talked about the different subcomponents of the treatment failure. One of the subcomponents, the change in mean BCVA. Could you confirm if that also looked comparable to phase II and better than that seen with HUMIRA? We have gotten some questions on that. And then one technical clarification. Rescue meds seem to be handled as failures. How were the discontinuations handled in the stat plan and whether this handling is comparable to HUMIRA's VISUAL I? And just lastly, as you think about the field force expansion, given this as a new physician call point, how should we think about that? Thank you so much.
Yes. I will take those in reverse order. They are all good questions. On the field force, I think the answer is we will provide more color on the specific sizes of things, probably starting on Investor Day and developing from there. So stay tuned. On the discontinuation handling versus VISUAL, I think the answer, I am going to hand over to Ben for the first of your questions so he can take the other one as well.
I think the discontinuation handling was the same as it was handled in the VISUAL program, which is a little bit different than the way the primary endpoint was defined in our own phase II, although we presented the data both ways. But the discontinuations were handled consistently here as in VISUAL. On BCVA, my only comment is everything looked strong and consistent across the map. That data is still being analyzed in part. It wasn't in the hierarchy of stats plans. It's a little bit of a different handling, but overall, it all looks very good. Ben, anything you'd add on BCVA or any of the other data points?
On BCVA, I would just highlight that all four of the components of treatment failure contributed to the results. We saw differences between drug and placebo across the board. I would also highlight that just the way this disease is managed is that the doctors, precisely because of what Matt was describing in terms of really today, even in many ways compared to when the VISUAL program was conducted, there's really even less of a tolerance for vision loss. The doctors really do not want these patients to worsen because they're of the view that they might not fully ever get better. I think often you'll see patients failing for one of the other criteria because doctors are monitoring the biomarkers carefully, and then they want to switch therapies before the patient has a 15-letter loss in acuity.
That's very much consistent with clinical practice in a growing way at these uveitis centers as Matt described upfront. That said, there were patients who failed for BCVA, and like I said, all four components, including that one, contributed to the total result.
Thanks, Ben. Just two other points just to close the loop. One is discontinuation handling, just to be clear, didn't matter in the results. BCVA, which we presented in academic conference and which was great, also hits that stage. Thanks, Prakhar.
Thank you. Our next question coming from the line of Douglas Tsao with H.C. Wainwright. Your line is now open.
Hi. Good morning. Thanks for taking the questions and congrats on the data. Matt, I think at the beginning of the call, you talked about how patients are treated very differently by uveitis specialists versus more general treaters in the community. I am just curious if you have a sense of both the split between patients between the two and how a patient ultimately ends up being treated by a uveitis specialist. Thank you.
Yeah, thanks, Doug. Again, we will hit more of this at the Investor Day in December, including numbers on the split. There are tens of thousands of patients, at least, treated at the uveitis specialty centers. There is a little bit of a gray area where there are some community docs that are double-boarded or have uveitis fellowships in some centers that are really concentrated. So it is not exactly a bright line. Part, by the way, of the reason I say that is what I expect many people are going to do in the coming days, given the quality of this data, is make doc calls. I think it is important to talk to docs who use systemic therapy to treat these patients, because they are the ones who really contextualize this data and the way they are managed in that sense.
How do these patients get to these centers? In part, the answer to that question is, the way they get by community physicians who do not do a lot of systemic therapy management, there is sort of a flare and response cycle. What winds up happening is these patients come in, they flare, and they get treated with something, either a high dose steroid or something local, an injection, and then they are better for a little bit, then they flare again. Eventually, frankly, these community docs, the retina specialists do not want to keep treating these patients. It is not their area of expertise. The referral is often sort of bidirectional. There is the doc themselves would prefer to be in the procedure business in many cases and wants to get out of systemic management. So they are happy to refer.
Also, these patients are sick, they're losing sight, so they're aggressively seeking expert therapy, and they're eager to find a good place to be themselves. So it's a combination of different things. Thanks, Doug.
Thank you. Our next question in queue coming from the line of Chi Fong with Bank of America. Your line is now open.
Hey, guys. Good morning. Thanks for taking my questions. My question is on the filing for brepocitinib NIU. What are the gating factors to filing as we think about the first half '27 window? And secondarily, brepocitinib has fast track designation for NIU. Do you assume a standard review or priority review for the sNDA? Thanks so much.
Thanks. That's a great question. I don't have an answer sitting here right now other than this is great data, and we think it is important to get the drug approved as quickly as possible. And we're working along that axis in every way that we can, and we'll provide an update when the sNDA has been accepted, and we have a PDUFA date. Thanks, Chi.
Thank you. Our next question coming from the line of Andy Chen with Wolfe Research. Your line is now open.
Hi, guys. Thank you so much. Just wanted to ask a quick question about the market share poll that you guys have. What is the pool of untreated NIU patient eligible for brepocitinib versus HUMIRA experienced patients? Within the untreated population, how many actually require systemic therapy, and how should we think about the prevalent patient opportunity at launch versus annual new patient starts? Thank you.
Yeah, thanks. These are all great questions about the market opportunity, and we do think there is a lot more work to do in the world for people to understand just how many of these patients there are. There are lots of NIU patients, and frankly, there is a variety of reasons why HUMIRA is used where it is used. Many of these patients have comorbidities. I think there is a lot to talk about here, much of which we are going to cover in detail in December.
I will say there is a huge opportunity just concentrated in the sick patient population today that is on best available therapy and not well-managed, that are often on and off high-dose steroids. In some cases, +20 mg of steroids being used. These are sick patients who are losing their sight. I think there is a sort of "easy" sort of first call point.
There are 50,000 patients systemically treated today. As we said, potentially upwards of 100 or plus 200,000 patients overall, many of whom are poorly managed in this flare and retreat cycle. Lots to do. Again, excited to talk more about it in December. Great. Thank you.
Thank you. There are no further questions in the Q&A queue at this time. I will now turn the call back over to Mr. Matt Gline for any closing comments.
Great. Look, thank you again, everybody, for listening. It is always fun when these things work. It is always fun to put out data like this. I think this is head-turning data that is going to matter to physicians, it is going to matter to patients. This is a disease with really bad morbidity. I always do this, but you should go on Reddit to the uveitis subreddit and look at how patients talk about their experience with disease.
This is a tough diagnosis, a tough situation, and it is just phenomenal to be able to make a difference. So thank you again to the investigators and the patients who entrusted us with their care here. Thank you to the Priovant and Roivant teams, to Ben and everybody who ran this study. It is a great outcome, and we couldn't be more excited to be taking this one forward and advancing other indications as well. Thank you all and look forward to catching up again in a couple of weeks with the Q. Thanks, everybody.
Ladies and gentlemen, that does end our conference for today. Thank you for your participation, and you may now disconnect. Goodbye.