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spk16: Good day and thank you for standing by. Welcome to the Concert Pharmaceuticals First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Justine Konigsberg. Please go ahead.
spk03: Good morning and welcome to Concert Pharmaceuticals first quarter 2021 investor update. Our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Roger Tung, our CEO, will provide the CTP 543 key highlights, and then Mark Becker, our CFO, will walk you through the first quarter financials. We will then be joined by Nancy Stewart, our Chief Operating Officer, and Jim Casella, our Chief Development Officer, for the Q&A portion of the call. As a reminder, today's discussion will include forward-looking statements about our future expectations, plans, and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10-Q filed with the SEC. Any forward-looking statements speak only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call. With that, I would now like to turn the call over to Roger.
spk13: Thank you, Justine. We're committed to advancing CTP543 through the Phase 3 program and anticipate filing our NDA in early 2023. We're very happy with the efficacy and safety profile CTP543 has shown thus far, and based on the competitive data we've seen to date, continue to believe that it may be best-in-class treatment for alopecia areata currently in development. We're pleased with the overall progress of the CTP543 program, which is advancing as planned. We're on track to initiate ThriveAA2, our second Phase 3 trial this quarter, as projected. The study will enroll approximately 440 patients with moderate to severe alopecia areata and is similar to ThriveAA1 in design. The Phase 3 data are expected next year. As a reminder, our robust clinical results, which have been presented at a number of medical meetings, including, most recently, data from our open-label long-term extension study, show that CTP543 treatment maintains or improves hair regrowth beyond 52 weeks. We plan to present an update on the ongoing long-term extension study during the second JAK Inhibitors Drug Development Summit on July 1st. Additionally, looking at our SALT20 analysis in the Phase 2 study, which is the primary efficacy endpoint in our Phase 3 trials, we saw statistically significant differences from placebo for the CTP543 8 mg and 12 mg twice daily cohorts at 24 weeks. Specifically, 42% of patients treated with 12 mg of CTP543 twice daily achieved an absolute salt score of less than or equal to 20. In the 8-milligram cohort, 26% of patients achieved an absolute salt score of less than or equal to 20. These results are clinically meaningful. Based on the data presented to date from industry-sponsored trials, we believe our findings represent the most robust efficacy results of any compound being developed to treat alopecia areata. A recent epidemiological assessment of alopecia areata in the U.S. indicates that between 700,000 and 1.6 million patients currently have the disease with upwards of 40% of those patients suffering scalp hair loss of 50% or greater. It's becoming increasingly widely recognized that alopecia areata is an important medical condition with no approved treatment and in many patients exerts significant emotional and psychological impact including depression or anxiety, and is associated with other comorbid autoimmune conditions. There's an enormous need for an FDA-approved treatment, and we're proud that Concert was one of the first in the industry to take notice of this important disease by advancing CTP543. We continue to push forward its development with a goal to file our NDA in early 2023. For the immediate future, we intend to invest our resources in advancing CTP543. Patients with alopecia areata have waited a long time for an effective treatment. We're developing something that we believe will be clinically meaningful to patients and expect to continue to be a major force in the field. Let me pause here and turn the call over to Mark.
spk05: Thank you, Roger. As I review our first quarter 2021 financial results, please reference the financial tables found in today's press release. Research and development expenses were $18.5 million during the first quarter of 2021 compared to $14 million during the same period in 2020. The Q1-21 increase was primarily related to the ongoing CTP-543 Phase III Thrive AA clinical program. We expect R&D expenses to increase as we initiate our second Phase III trial for CTP543 this month. General and administrative expenses were $5.5 million during Q1 2021 compared to $4.7 million for the same period in 2020. The Q1 2021 increase is attributable to higher external professional service expenses and non-cash stock-based compensation. Our net loss for Q1 2021 was $22.7 million, or $0.67 per share, compared to a net loss of $20.5 million, or $0.70 per share, during the same period in 2020. Finally, we ended the first quarter of 2021 with $111.8 million in cash, cash equivalents, and investments. Under our current operating plan, we expect our cash, cash equivalents, and investments to fund the company through 2021. This concludes our prepared remarks, and we would be happy to address any questions.
spk16: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Maury Raycroft with Jefferies. Your line is now open.
spk08: Hi. Good morning, everyone. Thanks for taking my questions. First one that I wanted to ask on is just with recruitment for the first 543 Phase 3, particularly on top of COVID. Just if you can provide any more specifics on how it's going and how site activation is going in the U.S. and internationally.
spk07: Sure. Hi, Maury. This is Jim. So great question. We are doing very well. the trial is ongoing. We have our U.S. and Canadian sites are all doing very well, and we brought on the European sites. So I think given the experience we had last year running trials under COVID, we learned a lot. We have a great team that is now experienced under these conditions. So I think things are going according to plan. And just as a reminder, we are going to be kicking off our second phase three study as planned in this quarter. Got it.
spk13: And just a... Hi, this is Roger. Sorry, I apologize. I dropped off the call.
spk08: Hi, Roger. Yeah, first question was just on the first phase three and how enrollment is going for that one. And I guess your comments, Jim, as follow-up, I'm just wondering for the second phase second phase three, as you get that started, what the strategy is there for activating sites and enrolling patients internationally. If there's any more specifics you guys can mention on that.
spk07: Yeah, no. Look, it's a very competitive space out there right now, and we have our sites selected. Things are progressing very nicely. We have... good data that drives our enrollment. And we also have an ongoing open label extension study which has been very, very useful in our recruitment activities because patients know that even though we have placebo controlled trials that we are able to flip people into the open label extension study where they would go on active treatment. So I think we've optimized all of our trial designs and our program. to really facilitate enrollment into the program. So running these trials simultaneously, we don't believe is going to be any issue.
spk08: Got it. Okay. And also wanted to ask a question about cash runway and financing strategy over the next 12 to 18 months. Just wondering if you guys could talk about scenarios like milestone payments from partners or potentially how a trial delay could impact your decisions going forward.
spk12: Mark, can you take that?
spk06: Sure. Yeah, thanks, Maurice. So, you know, look, we're a late-stage company now. We're in Phase 3. We've got Second Phase 3 about to kick off. And so, you know, no doubt we'll have to bring in capital. There is a capital need. And so we do have cash through the end of this year, and we're always assessing, you know, dilutive and non-dilutive opportunities. We also have an ATM out there. So we're exploring all those options as we speak.
spk08: Got it. Okay. And last quick question just on the DDI studies that are being conducted alongside the Phase 3s as part of the normal NDA packaging and labeling support. Just wondering if you can comment on the progress with those.
spk07: Sure. Maury, Jim again. So, yeah, those are going to be studies that will support the NDA. Things are moving very nicely there. You know, we have a great early development team in our clinical team, and those studies are progressing very nicely. We will have a number of those that will support the NDA, and we're on track to have all those completed by the time we file. Great.
spk08: Okay. Thank you for taking my questions. Sure thing.
spk16: Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is now open.
spk04: Hi, thanks for taking the questions. First one, just a quick one on the second phase three trial you're about to start. I know you said that, Roger, they were similar. Can you just remind us of any meaningful differences in the trial design? And then also, can you talk about the overlap in potentially enrollment sites between the two studies?
spk13: I'll start and then kick it over to Jim. Thanks very much for the question, Jason. So the endpoints will be the same for the two studies. The second one will be smaller because we'll have enough patients who will have been exposed to CTP543 to produce what we believe will be a quite robust safety database. And it will also be more robust there will be more sites in your second study. And Jim, do you want to comment further?
spk07: Yeah, no, that's basically right. I mean, we have picked centers that will meet our enrollment criteria. So, in some cases, we have high-enrolling centers that are capable of participating in more than one study. In other cases, we have the centers just responsible for one study. So I think part of that process of selecting our centers is really geared towards being able to run both studies efficiently. And as Roger said, we are taking opportunities to run some more European centers for the second phase three trial. As you know, there's not a lot of going on in Europe at this time, so there's a lot of fresh patients there.
spk04: Great. Helpful. And then second question from me, just Can you give us any update on the PTAB review of the 659 patent? I think you'd said last quarter that there was a potential for a post-grant review in mid-May. Is that still possible? And then what would be the next steps following that? Thanks.
spk13: Sure. So PTAB is currently reviewing the PGR review petition that Insight had filed against the 659 patent. They filed their initial petition and we have responded to it. There's been additional back and forth on that. We expect that they should have a decision on whether or not to initiate a PGR review around the middle of this month. So if they do decide to initiate that review, our expectation is that it will be conducted and completed within a calendar year of the initiation of that time. We believe that we have good arguments for why the argument petitioned by Insight is really not valid. So our hope is that it will not be instituted. But even if it is, we think that that's a strong patent that will survive any challenges. Okay, great.
spk04: Helpful. Thanks for taking the questions. Great, thanks.
spk16: Thank you. Our next question comes from Esther Hong with Barenburg. Your line is now open.
spk02: Hi, good morning. Two questions from me. First, can you speak about the competitor treatments and development for alopecia areata? And then second, separately regarding additional pipeline opportunities, can you speak about any clinical or preclinical results for CTP543 in other therapeutic areas? Thanks.
spk13: Hi, Esther. So, I'll take a first crack at that, and if Jim wants to follow up and welcome his thoughts on that. So, the only entities which currently are in development that have any clinical data associated with them are baricitinib and ritlicitinib. The data for those has been available for a while. The most recent release has been by Lilly earlier this year. I think it might actually be this month. They had released phase three data on baricitinib. And the data that they have indicates that there is statistically significant responses at the SALT20 score. But we feel that based on the data that we've seen across multiple phase two studies, with CTP543, we believe that 543's results are more robust than baricitinib, both at the 2 milligram and the 4 milligram dose strength. So, specifically, what Lily indicated is in that the BRAVE AA1 and AA2 studies They were seeing between 33% and 35% SALT20 response at the 4 milligram level and between 19% and 22% response at the 2 milligram level. And those are both at 36 weeks. In contrast, our responses have been measured at 24 weeks, so a significantly earlier timeframe. And at our 8 milligram and 12 milligram twice daily doses, we saw 26% and 42% responses respectively. So I'll just leave it at that. For ritlicitinib, we are awaiting the readout from their Phase 2-3 study. And so, you know, we don't have an appropriate late-stage comparison there yet.
spk02: Great. That's really helpful. And then just the additional pipeline opportunities, you know, of CTP543 beyond autoimmune disorder.
spk13: Right. So clearly with a JAK1, 2, and TIK2 profile of activity, CTP543 is expected to be active in additional disease states beyond alopecia areata, as you noted. We have really focused our efforts today on the treatment of alopecia areata, so we don't have additional disease state information to share at this time. We have spent quite a bit of time looking at follow-on indications for 543 and have identified a very short list of indications which would be of high interest to us as we go forward. But for competitive reasons, we're really not going to talk about those at the present time.
spk02: Okay, got it. Thank you. So helpful.
spk13: Yeah, thanks, Esther.
spk16: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. Our next question comes from Tisa Yang with Mizuho Securities. Your line is now open.
spk15: Hi, good morning, and thanks for taking my question. Just a question on the JAK in general. Wondering if you could comment a bit on how you think about the safety of JAK inhibitors in general versus CTP543, given the recent developments around safety in this space? we think about the differentiation among these compounds versus a potential class effect.
spk13: Hi, Jifei. Thanks for the question. So, with respect to JAK inhibitors, it's clear that there are both class effects associated with JAK inhibitors to date, or there appear to be class effects. And there are also idiosyncratic effects with the individual compounds as one would expect to see with small molecule inhibitors that may be related to either off-target effects or differences in terms of the relative inhibition of different JAKs that differ from molecule to molecule. We think that FDA is clearly trying to understand the relative similarities and differences, and we've seen now a couple of, a couple of PDUPA dates that have been pushed back so that FDA can get additional information and better assess those aspects. We think with respect to Well, first of all, there are numerous JAK inhibitors that are approved now across multiple indications, and it's clear that they have great utility and that they will continue to be used in the future. The specifics around the classes and the individual compounds, I think, will be addressed over the course of the next year. probably half a year as FDA assesses its information. And of course, individual compounds will be assessed over time as their data becomes clarified in a larger population. Our view is that this will largely be a case-by-case situation where the safety and efficacy profiles of compounds in individual disease states will be addressed and assessed by FDA. One of the facts of alopecia areata is that some of the mechanisms of action of treatment of other disease states, of other inflammatory disease states, are not as effective in alopecia areata as they are in, for instance, rheumatoid arthritis. And so the The choices of compounds that will be effective in alopecia areata for the foreseeable future will be fairly limited. JAK inhibitors have shown the greatest efficacy to date that I'm aware of in the treatment of alopecia areata versus other modalities, and so it's our expectation that the risk-benefit profile will skew favorably for the use of JAK inhibitors. And, of course, as we've discussed before with respect to CTP543 itself, we've been very happy with the overall safety profile of the compound and are developing a quite substantial safety database with long-term exposure to 543 that we'll be able to provide to FDA at the time of our NDA submission.
spk14: Oh, thank you. Very helpful.
spk16: Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Justine Konigsberg for closing remarks.
spk03: Thank you, Joelle. We'd like to thank everyone for joining us this morning, and we look forward to keeping everybody updated on our progress. For a list of upcoming investor conferences, please visit the events page within the investor section of our website. This concludes today's call. Thank you.
spk16: This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you. Thank you. Thank you. Bye. you
spk00: Bye.
spk16: Good day and thank you for standing by. Welcome to the Concert Pharmaceuticals' first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Justine Konigsberg. Please go ahead.
spk03: Good morning and welcome to Concert Pharmaceutical's first quarter 2021 investor update. Our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Roger Tung, our CEO, will provide the CTP 543 key highlights, and then Mark Becker, our CFO, will walk you through the first quarter financials. We will then be joined by Nancy Stewart, our Chief Operating Officer, and Jim Casella, our Chief Development Officer, for the Q&A portion of the call. As a reminder, today's discussion will include forward-looking statements about our future expectations, plans, and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10Q filed with the SEC. Any forward-looking statements speak only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call. With that, I would now like to turn the call over to Roger.
spk13: Thank you, Justine. We're committed to advancing CTP543 through the Phase 3 program and anticipate filing our NDA in early 2023. We're very happy with the efficacy and safety profile CTP543 has shown thus far, and based on the competitive data we've seen to date, continue to believe that it may be best-in-class treatment for alopecia areata currently in development. We're pleased with the overall progress of the CTP543 program, which is advancing as planned. We're on track to initiate ThriveAA2, our second Phase 3 trial this quarter, as projected. The study will enroll approximately 440 patients with moderate to severe alopecia areata and is similar to ThriveAA1 in design. The Phase 3 data are expected next year. As a reminder, our robust clinical results, which have been presented at a number of medical meetings, including, most recently, data from our open-label long-term extension study, show that CTP543 treatment maintains or improves hair regrowth beyond 52 weeks. We plan to present an update on the ongoing long-term extension study during the second JAK Inhibitors Drug Development Summit on July 1st. Additionally, looking at our SALT20 analysis in the Phase 2 study, which is the primary efficacy endpoint in our Phase 3 trials, we saw statistically significant differences from placebo for the CTP543 8 mg and 12 mg twice daily cohorts at 24 weeks. Specifically, 42% of patients treated with 12 mg of CTP543 twice daily achieved an absolute salt score of less than or equal to 20. In the 8-milligram cohort, 26% of patients achieved an absolute salt score of less than or equal to 20. These results are clinically meaningful. Based on the data presented to date from industry-sponsored trials, we believe our findings represent the most robust efficacy results of any compound being developed to treat alopecia areata. A recent epidemiological assessment of alopecia areata in the U.S. indicates that between 700,000 and 1.6 million patients currently have the disease with upwards of 40% of those patients suffering scalp hair loss of 50% or greater. It's becoming increasingly widely recognized that alopecia areata is an important medical condition with no approved treatment and in many patients exerts significant emotional and psychological impact including depression or anxiety, and is associated with other comorbid autoimmune conditions. There's an enormous need for an FDA-approved treatment, and we're proud that Concert was one of the first in the industry to take notice of this important disease by advancing CTP543. We continue to push forward its development with a goal to file our NDA in early 2023. For the immediate future, we intend to invest our resources in advancing CTP543. Patients with alopecia areata have waited a long time for an effective treatment. We're developing something that we believe will be clinically meaningful to patients and expect to continue to be a major force in the field. Let me pause here and turn the call over to Mark.
spk05: Thank you, Roger. As I review our first quarter 2021 financial results, please reference the financial tables found in today's press release. Research and development expenses were $18.5 million during the first quarter of 2021 compared to $14 million during the same period in 2020. The Q1-21 increase was primarily related to the ongoing CTP-543 Phase III Thrive AA clinical program. We expect R&D expenses to increase as we initiate our second Phase III trial for CTP543 this month. General and administrative expenses were $5.5 million during Q1 2021 compared to $4.7 million for the same period in 2020. The Q1 2021 increase is attributable to higher external professional service expenses and non-cash stock-based compensation. Our net loss for Q1 2021 was $22.7 million, or $0.67 per share, compared to a net loss of $20.5 million, or $0.70 per share, during the same period in 2020. Finally, we ended the first quarter of 2021 with $111.8 million in cash, cash equivalents, and investments. Under our current operating plan, we expect our cash, cash equivalents, and investments to fund the company through 2021. This concludes our prepared remarks, and we would be happy to address any questions.
spk16: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Maury Raycroft with Jefferies. Your line is now open.
spk08: Hi. Good morning, everyone. Thanks for taking my questions. First one that I wanted to ask on is just with recruitment for the first 543 Phase 3, particularly on top of COVID. Just if you can provide any more specifics on how it's going and how site activation is going in the U.S. and internationally.
spk07: Sure. Hi, Maury. This is Jim. So great question. We are doing very well. the trial is ongoing. We have our U.S. and Canadian sites are all doing very well, and we brought on the European sites. So I think given the experience we had last year running trials under COVID, we learned a lot. We have a great team that is now experienced under these conditions. So I think things are going according to plan. And just as a reminder, we are going to be kicking off our second phase three study as planned in this quarter. Got it.
spk13: This is Roger. Sorry, I apologize. I dropped off the call.
spk08: Hi, Roger. Yeah, first question was just on the first phase three and how enrollment is going for that one. And I guess your comments, Jim, as follow-up, I'm just wondering for the second phase, second phase three, as you get that started, what the strategy is there for activating sites and enrolling patients internationally. If there's any more specifics you guys can mention on that.
spk07: Yeah, no. Look, it's a very competitive space out there right now, and we have our sites selected. Things are progressing very nicely. We have... good data that drives our enrollment. And we also have an ongoing open-label extension study which has been very, very useful in our recruitment activities because patients know that even though we have placebo-controlled trials that we are able to flip people into the open-label extension study where they will go on active treatment. So I think we've optimized all of our trial designs and our program. to really facilitate enrollment into the program. So running these trials simultaneously, we don't believe is going to be any issue.
spk08: Got it. Okay. And also wanted to ask a question about cash runway and financing strategy over the next 12 to 18 months. Just wondering if you guys could talk about scenarios like milestone payments from partners or potentially how a trial delay could impact your decisions going forward.
spk12: Mark, can you take that?
spk06: Sure, yeah, thanks, Maury. So, you know, look, we're a late-stage company now. We're in phase three. We've got second phase three about to kick off. And so, you know, no doubt we'll have to bring in capital. There is a capital need. And so we do have cash through the end of this year, and we're always assessing, you know, dilutive and non-dilutive opportunities. We also have an ATM out there. So we're exploring all those options as we speak.
spk08: Got it. Okay. And last quick question just on the DDI studies that are being conducted alongside the Phase 3s as part of the normal NDA packaging and labeling support. Just wondering if you can comment on the progress with those.
spk07: Sure, Maury, Jim again. So, yeah, those are going to be studies that will support the NDA. Things are moving very nicely there. We have a great early development team in our clinical team, and those studies are progressing very nicely. We will have a number of those that will support the NDA, and we're on track to have all those completed by the time we file.
spk08: Great. Okay. Thank you for taking my questions. Sure thing.
spk16: Thank you. Our next question comes from Jason Butler with JMP Securities. Your line is now open.
spk04: hi thanks for taking the questions uh first first one just just a quick one on the the second uh phase three trial you're about to start can you i know you said that roger they were similar can you just remind us of any um meaningful differences in in the trial design and then um also can you talk about the overlap in in potentially enrollment sites between the two studies
spk13: I'll start and then kick it over to Jim. Thanks very much for the question, Jason. So the endpoints will be the same for the two studies. The second one will be smaller because we'll have enough patients who will have been exposed to CTP543 to produce what we believe will be a quite robust safety database. And it will also be more robust there will be more sites in Europe for the second study. And Jim, do you want to comment further?
spk07: Yeah, no, that's basically right. I mean, we have picked centers that will meet our enrollment criteria. So in some cases, we have high-enrolling centers that are capable of participating in more than one study. In other cases, we have the centers just responsible for one study. So I think part of that process of selecting our centers is really geared towards being able to run both studies efficiently. And as Roger said, we are taking opportunities to run some more European centers for the second phase three trial. As you know, there's not a lot of going on in Europe at this time, so there's a lot of fresh patients there.
spk04: Great. Helpful. And then second question from me, just Can you give us any update on the PTAB review of the 659 patent? I think you said last quarter that there was a potential for a post-grant review in mid-May. Is that still possible? And then what would be the next steps following that? Thanks.
spk13: Sure. So PTAB is currently reviewing the PGR petition that Insight had filed against the 659 patent. They filed their initial petition and we have responded to it. There's been additional back and forth on that. We expect that they should have a decision on whether or not to initiate a PGR review around the middle of this month. So if they do decide to initiate that review, our expectation is that it will be conducted and completed within a calendar year of the initiation of that time. We believe that we have good arguments for why the argument petitioned by Insight is really not valid. So our hope is that it will not be instituted. But even if it is, we think that that's a strong patent that will survive any challenges.
spk04: Okay, great. Helpful. Thanks for taking the questions. Great, thanks.
spk16: Thank you. Our next question comes from Esther Hong with Barenburg. Your line is now open.
spk02: Hi, good morning. Two questions from me. First, can you speak about the competitor treatments in development for alopecia areata? And then second, separately regarding additional pipeline opportunities, can you speak about any clinical or preclinical results for CTP543 in other therapeutic areas? Thanks.
spk13: Hi, Esther. So I'll take a first crack at that, and if Jim wants to follow up, welcome his thoughts on that. So the only entities which currently are in development that have any clinical data associated with them are baricitinib and ritlicitinib. The data for those has been available for a while. The most recent release has been by Lilly earlier this year. I think it might actually be this month. They had released phase three data on baricitinib. And the data that they have indicates that there is statistically significant responses at the SALT20 score. But we feel that based on the data that we've seen across multiple phase two studies, with CTP543, we believe that 543's results are more robust than baricitinib, both at the 2 milligram and the 4 milligram dose strength. So, specifically, what Lily indicated is in that the BRAVE AA1 and AA2 studies They were seeing between 33% and 35% SALT20 response at the 4-milligram level and between 19% and 22% response at the 2-milligram level. And those are both at 36 weeks. In contrast, our responses have been measured at 24 weeks, so a significantly earlier timeframe. And at our 8-milligram and 12-milligram twice-daily doses, we saw 26% and 42% responses respectively. So I'll just leave it at that. For ritlicitinib, we are awaiting the readout from their Phase 2-3 study. And so, you know, we don't have an appropriate late-stage comparison there yet.
spk02: Great. That's really helpful. And then just the additional pipeline opportunities, you know, of CTP543 beyond autoimmune disorder.
spk13: Right. So clearly with a JAK1, 2, and TIK2 profile of activity, CTP543 is expected to be active in additional disease states beyond alopecia areata, as you noted. We have really focused our efforts today on the treatment of alopecia areata, so we don't have additional disease state information to share at this time. We have spent quite a bit of time looking at follow-on indications for 543 and have identified a very short list of indications which would be of high interest to us as we go forward. But for competitive reasons, we're really not going to talk about those at the present time.
spk02: Okay, got it. Thank you. So helpful.
spk13: Yeah, thanks, Esther.
spk16: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. Our next question comes from Tifei Yang with Mizuho Securities. Your line is now open.
spk15: Hi, good morning, and thanks for taking my question. Just a question on the JAKs in general. Wondering if you could comment a bit on how you think about the safety of JAK inhibitors in general versus CTP543, given the recent developments around safety in this space? we think about the differentiation among these compounds versus a potential class effect.
spk13: Hi, Jifei. Thanks for the question. So, with respect to JAK inhibitors, it's clear that there are both class effects associated with JAK inhibitors to date, or there appear to be class effects. And there are also idiosyncratic effects with the individual compounds as one would expect to see with small molecule inhibitors that may be related to either off-target effects or differences in terms of the relative inhibition of different JAKs that differ from molecule to molecule. We think that FDA is clearly trying to understand the relative similarities and differences, and we've seen now a couple of, a couple of PDUPA dates that have been pushed back so that FDA can get additional information and better assess those aspects. We think with respect to Well, first of all, there are numerous JAK inhibitors that are approved now across multiple indications, and it's clear that they have great utility and that they will continue to be used in the future. The specifics around the classes and the individual compounds, I think, will be addressed over the course of the next year. probably half a year as FDA assesses its information. And of course, individual compounds will be assessed over time as their data becomes clarified in a larger population. Our view is that this will largely be a case-by-case situation where the safety and efficacy profiles of compounds in individual disease states will be addressed and assessed by FDA. One of the facts of alopecia areata is that some of the mechanisms of action of treatment of other disease states, of other inflammatory disease states, are not as effective in alopecia areata as they are in, for instance, rheumatoid arthritis. And so the The choices of compounds that will be effective in alopecia areata for the foreseeable future will be fairly limited. JAK inhibitors have shown the greatest efficacy to date that I'm aware of in the treatment of alopecia areata versus other modalities. And so it's our expectation that the risk-benefit profile will skew favorably for the use of JAK inhibitors. And, of course, as we've discussed before with respect to CTP543 itself, we've been very happy with the overall safety profile of the compound and are developing a quite substantial safety database with long-term exposure to 543 that we'll be able to provide to FDA at the time of our NDA submission.
spk14: Oh, thank you. Very helpful.
spk16: Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Justine Konigsberg for closing remarks.
spk03: Thank you, Joelle. We'd like to thank everyone for joining us this morning, and we look forward to keeping everybody updated on our progress. For a list of upcoming investor conferences, please visit the events page within the investor section of our website. This concludes today's call. Thank you.
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