Hi. Good morning, everyone. We will continue with the next session, which is Cannixa Pharmaceuticals. Please note that this session will be audio only. And with that, I'm pleased to turn it over to CEO, Sanj Patel, who will kick it off with some introductory remarks.
Sanj?
Thanks, Paul. Good morning, and thanks obviously to Goldman Sachs for hosting us today. With me on the call are John Paolini, our Chief Medical Officer Ross Mote, the Arculus General Manager and Head of Commercial and Mark Legosa, who is our Chief Financial Officer. As always, please note that we will be making forward looking statements today that are subject to both risks and uncertainties. A review of these statements' risk are found under the heading of Risk Factors in our SEC filings.
We are happy to have the opportunity today to discuss our recent approval and launch of Arcolist in recurrent pericarditis as well as our broader portfolio of immune modulating assets. On March 18 this year, we announced the approval of Arclist as the 1st and only FDA approved therapy for patients with recurrent pericarditis. ARCLYST in recurrent pericarditis became commercially available on April 1, and we look forward to reporting our 1st full quarter of sales in our Q2 2021 earnings report. I'm also really excited today to announce today for the first time that the U. S.
Patent and Trademark Office issued a patent today covering the use of Arcolist in the treatment of recurrent pericarditis. And this patent provides protection that extends into 2,039 and that's 11 years beyond our orphan exclusivity. We also issued a press release this morning outlining the next steps for the development of mabrilimumab. We believe that our Phase 2 data in non mechanically ventilated patients with COVID-nineteen related ARDS suggest that mabrilimumab may be a best in class treatment option for these patients. And as such, we're focused on the continued development of mabrilinumab for patients with COVID-nineteen related ARDS.
And we believe this strategy represents the fastest path to potential registration for mabozlimab and there remains a significant unmet need for this patient population. Our Phase 3 trial in non mechanically ventilated patients has enrolled over 400 patients and we expect data in the Q1 of 2022. Turning to our other pipeline assets. We continue to execute on the development of bixolizumab and KPO-four zero four, which is our anti CD40 program. We're conducting a placebo controlled Phase 2b clinical trial of VIXA in prurigo nodularis and that's evaluating a range of once monthly dose regimens via subcutaneous injection.
And we also recently reported positive Phase 1 data for our potentially best in class CD40 program. And we plan to initiate a Phase 2 proof of concept trial in rheumatoid arthritis. So with those opening comments, I'll turn it back to you, Paul.
Thank you, Sanj. Maybe we can kick off the Q and A with this morning's news, and you did press release update on your development plans for mavrolumab. Can you maybe talk to us about the scope and nature of your FDA discussions and how you're prioritizing development of MAVI and just how we should think about the sequence there?
Yes, absolutely. And maybe I'll start and then John, if you want to jump in, feel free to. So obviously, our discussions, as we said, with the FDA have been favorable really across the range of potential indications for mabrolizumab. And that was on the heels really of the positive Phase 2 data that we had in COVID-nineteen related ADS as well as the positive Phase 2 data from our clinical trial in GCA. And we also had discussions with them around the indication of RA.
So as we said in the press release this morning, we believe that the fastest potential path to registration is the COVID related ARDS study. We've now enrolled over 400 patients. We're looking to enroll 600 patients as part of a Phase 3 study and hopefully then obviously be part of a registration there. We're also pleased though that we had a nice delineation potentially for the GCA indication. And so there what we said in the press release that, that would potentially be just a single pivotal Phase 3 study in GCA after that.
And then as far as RA is concerned, obviously not something that this company would pursue itself, but certainly not on its own, but it was really nice to have a potential regulatory path outlined working with the FDA potentially 2 Phase 3 studies in rheumatoid arthritis. But again, that's probably not something we would take on our own, but it's very nice to see the negotiations or discussions with the agency around mabolimumab broadly and see the potential broad utility. So that's really the order in which we'd progress things.
Great. That's great progress on the regulatory front. Maybe diving into your 2 earlier or most advanced opportunities, specifically, maybe starting with COVID here, you said earlier that you've enrolled about 400 patients with that aim of enrolling a total of approximately 600 patients. And then, I guess, as you think about this relative to your earlier data, what would be considered a good result here either for maybe from you can comment, Sanj or John possibly?
John, why don't I let you maybe do a very brief recap on the Phase 2 data that we saw and why we're so excited about the data in COVID. And then obviously move to the Phase 3, which as I said is enrolling very well.
Yes, happy to do so. Thanks, Hans, and good morning, Paul. Really a pleasure to speak with you. So yes, in April, we announced data from the Phase 2 portion of our clinical trial and that's a Phase twothree seamless design and that's in COVID-nineteen related ARDS. So the results that we showed were from the non mechanically ventilated patients.
And this signifies a potential additive treatment effect of mavrolizumab and that's on top of corticosteroids. And what we saw was a 65% reduction in the risk of mechanical ventilation and death. And that was in a diverse patient population. And when we look at mavrolizumab in the context of other treatments that are being evaluated, there is a real best in class potential here. And we were particularly encouraged by the benefit risk of GM CSF receptor inhibition with mavrolizumab given not only the fact that the treatment effect was sustained and was demonstrated throughout the 29 day observation period, And that was after only a single administration of drug, but also the fact that the safety profile demonstrated that mavrolimab is well tolerated to date.
So yes, so overall, we think that mavrolimumab is well differentiated and potentially best in class in the space of COVID-nineteen related ARDS. And we actually just as a side note, just recently had a scientific presentation of the data at the late breaking session at the EULAR Congress just on Friday morning Friday morning. So as we look at the Phase 3 data going forward, specifically to your question as to what to look for, remembering that this is a seamless design, right? The first 120 patients that went through were in Phase 2 and then we continue to enroll directly into Phase 3 with the same study design. What we're looking to do is essentially confirm and extend those findings from the Phase 2 portion into that larger patient population.
As you know, we've shared our data from Phase 2 with the FDA. And so we're kind of moving forward with our plans. We finalized the sample size, for example, to have the sample size be 600 patients. And as Sanj mentioned, we have already 400 of those patients enrolled. But maybe one last word, which is about kind of where do therapeutics fit in this situation where a lot of patients are being vaccinated.
So as you know, vaccination will always be the mainstay of the prevention paradigm. And so that's of critical importance. However, there really is a need, an unmet need for COVID therapeutics as well. And that's and specifically around these patients that are hospitalized with hypoxia that are at high risk of mechanical ventilation. As you know, these patients transition from when they first present, there's an early phase of a high viral replication and that's where antiviral therapies and the antibody cocktails have shown some benefit.
But it's really in that later phase of disease where there's that aberrant inflammatory response. That's what's causing the tissue response, the tissue damage, the thrombosis, the ARDS and death. And so in that sense, the therapeutic focus has to be on the host response rather than on the virus itself. And so I think especially in this situation globally where we're seeing very, very high almost uncontrolled viral transmission rates, for example, in Brazil and other parts of the world. Those case rates are increasing the likelihood of variants that could evade the protective effects of vaccines and cocktails.
So I think that's the fact that mavrolimumab blocks this counterproductive inflammatory response in a way that's agnostic to the coronavirus sequence is of great importance. So that's kind of how we view the overall development scheme.
Okay, great. Thanks for that, John. And your point on the existing opportunity in international geographies is well taken. With regard to your second key update in your this morning's press release with development in GCA. I guess the key thing here is that you can run a single Phase 3 trial here.
How do you think about executing on that and just what the timing on kicking that off potentially could be and just as you think about trial design here?
Yes. So I mean, obviously, we're really pleased with the discussions with the agency regarding that and that was on the heels of the very positive Phase 2 data that we had last year. So certainly, that's a path that we could follow. At this point, we're going to focus on getting the registration hopefully in COVID-nineteen related RBS. Depending on that data, we'll delineate or describe next steps for the rest of the programs.
But it's certainly, as you say, a nice development that we've got a potential to single pivotal Phase 3 study for registration in GCA. But we'll provide an update in the future as far as on our timing around that.
Okay, great. Thanks, Sanj. Maybe staying on the topic of GCA here, it seems like the clinical treatment paradigm is increasingly transitioning to biologics here. And how do you compare the MAVI data that you've had so far versus already approved products such as Actemra in terms of efficacy and safety that we've seen so far?
John, do you want to cover that?
Sure. Happy to do so.
So when we look
at the data from the Phase II study, we showed those at ACR last November. The primary efficacy endpoint was time to first adjudicated GCA flare at week 26, and we did that in the pooled population. And it was a statistically significant 62% lower flow rate in mavrolizumab recipients compared to placebo. And that was statistically significant, P value of 0.0263. And the secondary efficacy endpoint, if you look at the data from the other perspective, which is sustained remission at week 26 in all treated patients, that was 33.3 percentage points higher than avelimumab recipient.
So that means 83.2% of patients were in sustained remission at week 26 compared to just half of the placebo recipients. So that was also actually highly statistically significant, P0038. So what you see there, that's in the pool population carries forward into the subgroups of patients. And this is actually really important to the new onset and relapsing refractory cohorts. And marafolumab in particular seemed to do well in the relapsing refractory cohort and that was the group of patients where biweekly tocilizumab struggled in their Phase 3 pivotal registrational study of this Giacta.
So that 30.6 percentage point higher sustained remission rate in those relapsing refractory patients, it really compared quite favorably. I mean, cross trial comparisons are always tricky, but it was only 20 percentage points with tocilizumab. So overall, of course, mavrolizumab being well tolerated without drug related serious adverse events meant that and the fact that mavrolizumab and placebo drug related treatment emergent adverse event rates being similar really speaks to the safety profile of the drug to date. So when we put together this benefit risk profile And we also showed incidentally, as a side note, some recent data at the ULR meetings just this past weekend showing that acute phase reactants such as C reactive protein and the sedimentation rate, those are actually still reliable for monitoring disease activity where patients are being treated with mavilimumab. And that actually could be an important differentiation element for clinicians because with tocilizumab, which of course, as you know, suppresses CRP production in the liver independent of the inflammatory state, makes monitoring of those biomarkers more challenging or less reliable.
So taken as a whole, this upstream mechanism of bavrilimimab in this disease is very important to us and it blocks the activity of GM CSF in the downstream pathways. So we think that in that sense, there's a real opportunity to potentially be best in class in this disease. Back over to you.
Great. Thanks, John. How do you think about the opportunity for nivirumab in first line treatment naive patients versus refractory or treatment experienced patients. We will be focusing on one population more. Does one make sense or is easier to focus on in terms of development?
Yes. I think it will be both. From a prevalence perspective, if you look at giant cell arthritis patients, there are 75,000 to 150,000 patients in the U. S. Alone.
And those are essentially all being treated with corticosteroids first. 50% to 70% of those end up with relapsing refractory disease and they can't be tapered off of steroids and they become steroid dependent and it can often be for years. And so there's a real need for those patients. So when you look at the data and how patients are doing on standard of care and that includes the fact that there's one drug already approved as an adjunct dystrophin therapy, even still only half the patients can remain in sustained remission on a yearly basis with standard of care. So that's I think why we're excited about this mechanism, where by blocking GM CSF pathway, you end up blocking 2 key immune pathways that are implicated in the disease, right, the CH1 or the CH17 pathway.
And that I think is the key to the differentiation in addressing the underlying pathophysiology. So in that sense, for the subgroups, what our data have shown to date is that mavrolumab may actually offer differentiated treatment option really for both types of patients, relapsed and refractory disease as well as those with new onset disease.
Okay, great. That makes a ton of sense here. Maybe we can shift over to the commercial piece. And you did mention you'll talk about your updated ARCLIS launch coming up here. But can you maybe provide us some preliminary commercial updates since your recent approval and launch earlier this year?
And maybe some color on what physician feedback has been like?
Yes, absolutely. And Ross is on the line and certainly can provide sort of an overview where we are. But just to remind you, we had the approval in March. We launched the drug in April. We've obviously had the sales force in place by that time, that 27 reps with the cardiology focus, a lot of them with previous cardiology experience and relationships.
But we also had the MSL team in place for over 2 years. So that's really put us in good stead. But maybe Ross, you could provide a bit of color on the launch so far. And obviously, we'll look forward to reporting the Q2 sales in sometime in August.
Thanks, Anja. Very happy to do that. And Paul, thanks so much to speak to you again. Maybe just to take a step back
to begin with just as
a reminder, we received the breakthrough therapy designation, also the orphan drug designation, which led to a priority review and actually a slightly earlier approval versus the PDUFA date that got FDA approval on the 18th March. Now we have the commercial availability as of the 1st April. We were very pleased with the very broad label that we achieved with the approval as well, which is the treatment and the reduction of risk of recurrence and recurrent pericarditis. So whilst we're not providing specific metrics right now and we look forward to sharing information on our Q2 earnings report. We are very confident and happy with the commercial strategy that we put in place.
We really spent a lot of time prior to the approval, really understanding the marketplace and the patient journey. As Sanjay said, we have the MSLs in the field for a good couple of years prior to the launch as well on disease awareness and really working with subject matter experts within the area. And really through market research and triangulization of claims data, we were able to put together a very focused and targeted strategy. And that's really what led to our strategy around just under 30 clinical sales specialists that we now have activated out in the field. We have very tenured sales professionals within that group, which are from cardiology experience or biologics or rare disease experience and really focus on the targeted strategy, which is really understanding where the patients we put in, which centers are looking after those patients and which health care professionals are treating the patients as well.
So with the team of just under 30 representatives in the field, we feel like we can cover around 70% of the total recurrent pericarditis patients out there across the U. S. But in this early stage of launch, we're also really focused on a smaller group of that, which is around the 45% of the current pericarditis patients with a smaller number of accounts. And then once we're comfortable with the uptake within those accounts, we'll expand out to the 70% deciles as well. So we're really happy with the targeted approach that we have.
We're also very focused on the 4,000 to 8000 patients that fit into the multiple relapsing and the corticosteroid dependent patients, which is highly representative of the very compelling data we have out of RAPSODY. So we're focused on those groups. We believe there's a strong call to action with the physicians that look after those particular patients as well. So we're really focusing on mainly cardiologists, but also some rheumatologists that look after those patients as well. And today, the physician feedback has been very positive.
I mean, certainly, they're looking for better treatment options. There are previously no approved drugs within this particular field for recurrent pericarditis. Our drugs at the moment are really systemic and patients have often cycled through these drugs and continue to break through. And that's really where we're focused. So we're happy with how receptive physicians have been to the data.
And as we get out and reach more physicians, now we're at the early stages of launch.
Great. Thanks for that, Ross. Maybe as a follow-up, you guys received a very broad label here for Arclist without any meaningful restrictions as to regards to prior lines of therapy and so forth. So how is that how is the shape of the label resonating with regard to physician feedback?
So I think with good physician feedback is resonating very well. And I think also with payers as well. I mean, we were also really focused on the payer community in the prelaunch stage where we're doing early payer engagement with our payer team, who are now also fully operational out in the field. We had more than 150 payer engagements prior to the approval, which was really focused around recurrent pericarditis of the disease and the high level top line results from the Rhapsody data. So again, we're really focused on that customer group for us as well.
And again, on the 40,000 patients and ramping up after the approval in our engagements with that with those customer groups and really focus on ensuring that we have minimal payer restrictions within the target population. I guess one important thing to note is really in line with our previous expectations. We know that there are viable reimbursement conditions ahead of when payers are actually establishing their full coverage policies for other medical exceptions and processes. So we've seen after the viable routes up until the full coverage is and policies are in place, which we still expect the majority of those will be within 6 months of launch and almost all of them within 12 months and feeling confident that payers will appreciate the specific benefits of after this sort of targeted therapy in the first and only approved drug in this indication. And we've also launched Kinixa One Connect as our patient services program, which is really pivotal in supporting patient access and affordability really throughout the patient journey on Arclis.
Okay, great. Just you mentioned you'll get a decent chunk of the payer coverage in the next 6 months and present mostly all of it in the next year, I guess. Just I guess as you engage in those discussions, should we think about maybe any sort of big chunks of progress with regard to payer coverage coming? And just how do you expect in terms of the major payers and major providers coming on board, I guess, in the time frame provided?
Yes. Thank you. So we really we wait to see as those coverage policies start to come through. But as I mentioned, really feeling positive about the medical exceptions process prior to that happening. And I guess in some way, it helps us.
The fact that this drug has actually been available since 2,008 in caps and then the approval at the end of 2020 in DERA as well, another ultra rare monogenic disease. So payers are really quite familiar with ARPLIST as a mechanism of action, and they have some familiarity around that. So that may help during the medical process. And then we have a way for the coverage policies to come into place and we're actively engaging with payers, but prior to the launch now. Since launch, we've really kind of provided all of the value messaging among this disease and excited about the future.
Okay, great. Thanks for that, Ross. Maybe turning to the other parts of the pipeline here, and we can talk about bixarilumab and how it fits into the PN treatment landscape and what you've been working on since your positive Phase 2 data was previously published? And then maybe as a follow-up to that, how do you think about that, the Vixa data and development comparing to the nimolizumab Phase 2 data, which is also previously announced a while back ago?
Yes. Maybe, John, I'll start with a few sort of broad level comments and if you can just jump in with the positive Phase II data. But obviously, I want to remind everybody that there is currently no FDA approved therapy for prurigo nodularis and there are limited therapeutic options. The prevalence is around 300,000 in the United States alone and we feel this market could sustain multiple entrants, especially with different mechanisms. So right now, 1st line therapy is typically topical steroids and the second line includes oral corticosteroids on UV phototherapy.
The 3rd line therapy also involves systemic immunosuppressants, such as methotrexate, cyclosporin and belimumide. So it's obviously essentially great for patients that there could be a systemic therapy in development. So both ViXA and NEMO inhibit IL-thirty one, which has been shown to inhibit pruritus, but vixelizumab also inhibits oncustatinib M, which drives both fibrosis and hyperkeratosis and potentially, therefore, translates into lesion improvement over time. So we believe that the results we've had so far are very encouraging. We saw that from the Phase 2a study in ViXA that both pruritus and nodule response are suggestive of the potential for the drug to make a positive impact on patients with prurigo noduleura.
So obviously, really pleased with that. As you say, we're enrolling in the Phase IIb dose ranging study right now and that trial is ongoing. But maybe, John, if you want to just focus on the Phase IIa data as Paul asked about.
Sure. Happy to do so. Yes. So the Phase IIa data in Prager Nodularis showed the potential efficacy of this mechanism of OSMR beta inhibition. So specifically, the trial met the primary efficacy endpoint.
That was a reduction in weekly average worst age NRS from baseline to week 8. That was statistically significant within those receiving vixterolimab with a nearly 70% reduction in median weekly average worst age NRS at week 8. And importantly, when you think about the regulatory endpoint for clinical meaningfulness, which is a greater than 4.weekly average wastage NRS reduction, That was also statistically significant with a majority of vixarilumab recipients showing that. But the results really extended beyond pruritus and they went into the space of disease severity, which is important. 30.4 percent of vixironov recipients achieved a PNIGA score of 0 or 1, which is clear, almost clear at week 8 versus placebo recipients.
So as a secondary efficacy endpoint, that was highly statistically significant. So to your question of how do you put this into the competitive landscape with regard to the namalizumab data. So of course, one should always approach cross trial comparisons with some caution, but there are a few caveats to keep in mind when looking at the differences in the two study designs and then we can talk about the results. Obviously, precision around the point estimates, the NEMO study was bigger with 70 patients versus vixarolimab at 49 and slight differences in the patient population where the nimolizumab study was run-in Germany and vixarolimab primarily in the U. S.
And there are some subtle differences in how the disease is characterized or defined. But mechanistically, I think this is where it gets really interesting, where nimolizumab is blocking IL-thirty one only, whereas zixarilumab is blocking not only IL-thirty one, but also, as Sanj mentioned, oncocatin M inhibition. And we know that oncocatin M drives fibrosis and hyperkeratosis. So when we put that together in terms of those results with fixerilumab and the fact that in addition to the strong antipruritic response, seeing that robust disease severity benefit and lesion improvement And there's an interesting insight there. It's not just that the PNIG at week 8 and the delta was nearly a third of patients having that response versus only about like 10.6% in the nimolizumab patients.
What it means is that these patients were seeing that effect at week 8 was actually a similar magnitude and also statistically significant at week 6 and there was curse separation as early as week 4 in that Phase 2a study of ours, whereas the NEMO response was slower and had a smaller magnitude of response. Now, of course, we have to replicate these findings in work to replicate these findings in the Phase 2b study, and we have a 16 week study ongoing in order to do that. But at this point, the data that we have in hand speak to why we think why we believe at this time that vixiromab could in fact be potentially best in class asset in this space.
Okay, great. Thanks for that, John. In addition to your focus with Viksa in terms of developing it for PN, you have a lot of other things going on here, which include 404. Can you maybe talk about some of the proof of concept data that you have there and how you think about 404s role in T cell dependent and B cell mediated opportunities?
Yes. Maybe John, if I make a couple of comments and maybe you can jump in. But so first of all and foremost, we're really excited about this program. And I think I've said to you, Paul, in the past, a lot of that, Simon, also comes around from the fact that we own the vast, vast majority of the economics for this program. And we really believe it's got a potential to be a very strong value driver for the future of the company.
We recently did report final data from the Phase I trial. John can review that and that was very, very encouraging. And they really confirm and extend the findings that we found from the previously reported lower dose cohorts, which we reported in November of last year. So the data continues to reinforce our confidence in 404 as the potential best in class treatment option and really support the optionality of studying chronic dosing in patients with both subcutaneous and or intravenous administration. So based on that, we plan to continue the development of that program, potentially now in the Phase 2 proof of concept study in rheumatoid arthritis patients.
So maybe, John, a few additional details on the data and then really the broad potential applicability of this program. Yes.
Thank you, Sanj. So yes, the Phase I study with 404, that was a healthy volunteer study, single ascending dose, but it was still randomized double one placebo control. And what we saw, of course, were dose dependent increases in concentrations across cohorts and with safety and PK being the primary endpoints, of course, the safety showed dose limiting safety findings, KTL-four zero four is well tolerated, no serious adverse events. So speaking specifically to the data, back in November, we reported 3 mgkg IV data. And in that context, what we saw with that dose level, single dose was that receptor occupancy and suppression of the T cell dependent antibody response after KLH challenge.
We saw all those through day 29. And in fact, there was even complete suppression of the memory TDR response when we re challenged with antigen at day 29 with just the drug levels that were still remaining in circulation at the time from the prior administration. So the new data that we just reported are exciting because the higher dose data at 10 mgs per kilo ID extended the full receptor occupancy through at least day 71 and gave complete suppression of TTR after the KLH challenge and even re challenged through day 57. But I think the most exciting piece of data really speaks to the optionality of subcutaneous dosing going forward into patients. And there we used a 5 milligram per kilo subcutaneous dose, which actually could be practically administered going forward.
And that showed full receptor occupancy through day 43 and suppression of Tdar after KLH challenge through at least day 29, which is when we stopped measuring. Now another way of looking at the data is to look at anti drug antibodies and this is particularly useful in the competitive landscape. And we saw suppression of antidrug antibodies for at least 57 days for 10 mg per kilo IV. And that itself is an independent indicator of target engagement and pharmacodynamics. So now armed with these single dose data and healthy volunteers, we've now set the stage for that longer duration exposure in patients going forward and we can talk about that study if you like.
Okay, great. So the subcu optionality, I think, is really attractive here. Maybe you can elaborate a little bit more on the Phase 2 plans here in RA and just how you think about maybe identifying the population?
Go ahead, John.
Sure. Yes, sure. Happy to do that. So this trial is essentially a proof of concept study with a PK lead in. And so what we did was we selected rheumatoid arthritis patient population, primarily not so much because this is our broader plan, but rather as in a focused way for this particular study, trying to characterize the molecule as well as to look for evidence of early signal of efficacy, if you will.
This is a well characterized autoimmune disease and there are decades of published clinical data across diverse mechanistic classes. So in that sense, we can get an objective evaluation using established endpoints in a relatively small number of patients over a relatively brief period of time. So the way we're approaching this study and of course more details to come, but the first part of the study evaluates the safety and pharmacokinetics of KPL404 and subcutaneous administration. Essentially, we're bridging from the single dose HealthCE volunteer data into chronic dosing in patients. And then from there, we go up the dose escalation after the PK lead in with a 12 week proof of concept portion of the study.
And there we can use those rheumatoid arthritis endpoints and look for essentially the maximum horsepower of the mechanism and of the drug. And of course, more details to come as we file in clinicaltrials.gov at a later date. But maybe one last point, which is that with this study design, it really gives us optionality again to do proof of concept studies in other diseases if we want using those data in that ENHANZE. So in that sense, this planned study is important not only to characterize chronic administration of 404 in patient populations in general, but it provides that option to evaluate the therapeutic potential of KPL404 across a range of other autoimmune diseases with the pathologies that we believe have been mediated by the CD40 and CD154 or CD40 ligand pathway. And of course, you know that the literature is rich with a number of external proof of concept studies there.
So maybe I'll pause there.
Great. Thanks for that. Maybe we're coming up on time here. So we have maybe time for one more question, which is, Sanj, I sense your palpable enthusiasm for this program here. And just can you think about or help us understand how you think about the additional autoimmune opportunities for 404 here and what might make sense for future development?
So it's definitely palpable, the energy, and a lot of that, as I said, is around the economics. So as John said, we're going to use this space to proof of concept study to really help guide our decisions. I mean, we really think this could be a best in class molecule that we practically own. There are a number of autoimmune diseases that are out there. And it's and the nice part about this program is there's been external validation in a number of different indications, Schrogen's, etcetera, and other areas.
We think RA is the right one as far as proof of concept, some of our proxy as you will. But we definitely look forward to updating folks on the next steps and we'd like to make them as concurrent as possible certainly as far as other indications. So more to come, but it's a very, very exciting program.
Great. We'll have to end that on that note because we're up on time here. But thank you very much, Sasanjan, and the team for joining us today.
Cheers. Thanks, Paul. Thanks, everybody.
Thank you.
Thanks so much. Bye now.