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234. Bull, Bear & Beyond – SynAct Pharma: executive interview
12 Plays8 days ago
In this interview, we speak with Mads Bjerregaard, chief business officer of SynAct Pharma, following the release of top-line results from the Phase IIb ADVANCE study of resomelagon in rheumatoid arthritis. He discusses the key takeaways from the results, which did not achieve statistical significance on the primary DAS28-CRP endpoint but demonstrated encouraging efficacy signals, including an ACR20 response rate of 76.4% at the selected 40mg dose and significant efficacy in the ACR/EULAR Class II-III subgroup. Mads also highlights the significance of the biomarker and safety findings, the implications for SynAct’s differentiated pro-resolution approach and the potential impact on regulatory interactions, Phase III planning and partnering discussions. Finally, he discusses potential read-throughs for the ongoing RESPIRE study and the key milestones investors should watch over the next 12 months.
SynAct Pharma (STO: SYNACT) is a clinical-stage biotechnology company developing first-in-class therapies that promote inflammation resolution without suppressing the immune system. Its lead asset, resomelagon, is an oral melanocortin agonist being developed for rheumatoid arthritis and acute inflammatory conditions. Following the recent Phase IIb ADVANCE readout, the company’s focus is on regulatory engagement, Phase III planning and advancing the broader inflammation-resolution platform, including the ongoing Phase II RESPIRE study.
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Transcript
Introduction to Phase 2B Trial Discussion
00:00:07
Speaker
Hello and welcome to Edison TV. I'm Jyoti Prakash, Director of Healthcare care at Edison. Today, I'm joined by Mads Birgad, Chief Business Officer at Synact Pharma, to discuss the recently announced results from the Phase 2B Advanced Trial of Resumilligon in rheumatoid arthritis.
00:00:25
Speaker
Welcome, Mads. Well, thank you very much.
Efficacy and Biomarker Signals: Achievements and Challenges
00:00:28
Speaker
So, Mads, the advanced trial has generated several encouraging efficacy and biomarker signals, in particular related to ACR20.
00:00:39
Speaker
However, statistical significance on the primary DAS28 CRP endpoint was not achieved. So, how do you interpret the overall data set and what do you see as the key key takeaways for investors?
00:00:53
Speaker
Well, thank you for the question. Yeah, so, so we' We're actually very, very happy with the results from the advanced study. And and I think your point to the obvious highlight is that this study really gets ah or demonstrates the effect of Resmilk on a top of Mifotrexate.
00:01:13
Speaker
in early rheumatoid arthritis, delivering results on ACR20 levels and on part of what we've seen in past in and past trials, but really also on the levels that you would expect when when using more potent compounds like JAK inhibitors or even TNF blockers um that reach kind of this 75 to 80% ACR20 scores after 12-3-3 therapy.
00:01:38
Speaker
hcr twenty scores off twelfth re of therapy um And Resumeligon does the same, so it reaches 76.4% after 12 weeks of therapy, and which is equivalent to to what we saw in in in earlier trials.
00:01:54
Speaker
This is very encouraging and and obviously very much encouraging in terms of also the deepening of response in the ACR50 scores reaching almost 40%, which is is is highly encouraging and and and a measure that will only improve the longer duration of therapy you have. So really setting ourselves up for for a face-free design, which typically goes into these 24 weeks, week studies.
Phase 3 Design and DAS28 Challenges
00:02:23
Speaker
um So that is is super positive and and really what we are building the case around in terms of both the business logic and and they moving forward with the phase three design.
00:02:36
Speaker
Then you point out ah to the the primary endpoint on the reduction in DAS28. um we reach In this study, we actually reached a 2.0 reduction in DAS28, which is above what we saw in the subsets, the numbers of the EXPAND trial.
00:02:56
Speaker
But the difference here is that you also see in the control group on metrixate alone had a very high response, or much higher than what we saw in the EXPAND trial. um And it was so high that under the limitations of the the the sample size and and how this study is you know is scaled, um it was not able to reach significance in and on that endpoint. there's There's a couple of explanations for that. We are obviously looking into the data right now.
00:03:28
Speaker
And a couple of explanations is that patients were a little bit more sick than than in the in the ah in the EXPAND trial, and and that has a positive effect on on especially DAS28.
00:03:44
Speaker
Interestingly is actually what we did in in there when looking at the subgroups, ACR, EULAR subgroups ah one through three,
00:03:55
Speaker
where one basically is you know the least ah sick patients in in that subgroup. and When we just focus on on the more sick, so group two and three, that increased the effect of seeing an ACR20 response, um which tells us something about the resimelagon works really well when people are you know having a lot of inflammation and are in the sicker category. and which also coincide with how metrotrexate works, then probably works better with kind of the earlier stage.
00:04:30
Speaker
um So DAS28, we you know unfortunately didn't meet the endpoint due to very high placebo score, but very, very nice on the ACR20 scores and subsequent the ACR50 scores, reaching and you know just shy of 80 and 40% scores, which is fantastic.
00:04:54
Speaker
Exactly. And indeed, I think the ACI 20 scores are quite encouraging. Upwards of 75 is, I think, a great
ACR Responses and Future Applications
00:05:01
Speaker
score. But when we look beyond these headline data, what are some of the other aspects of the advanced trial which you believe are most important for investors to understand?
00:05:14
Speaker
so So I think that there are two things or three things that that that that we really want to communicate based and on on these on this trial and and which I think is is just reads loud and clear. one is the the ACR response and when that picks in or when that that picks up in in the Resovellagon group and and what that would go for in a phase 3 design moving forward. I think the you see the ACR response really popping up in after week 8, so a little later than than what you would expect from JAK inhibitors and TNF blockers. which really speaks to that full extent of the the the effect has not been reached within the 12 weeks, which is amazing because you get good results and that continue.
00:06:04
Speaker
um So that goes really well for face-free design. Then safety, by all means, that is we experience... a that The study demonstrates a safety profile that we've also seen in previous trials with really benign side effect profile with very few transient GI effects, for example, and with absolutely no signs of immunosuppression. and And I think the safety profile is really the key differentiator to a compound like this because that enables us to use it very early on which is is is how we position this.
00:06:42
Speaker
And then thirdly, I think very importantly is that we also see um significant reduction in key inflammation inflammation markers like CRP, ah NLR, so neutrophil, leukocyte, radio, um which is really measures systemic inflammation. And we see a significant reduction in those radios.
00:07:07
Speaker
That tells us that the mechanism or the pro-resolving mechanism of resomelagon really works to reduce inflammation in in this population. So that's not only interesting for what we're doing in rheumatoid arthritis, but really interesting how this mechanism can be brought out to a lot of other inflammmatic inflammatory diseases. so We're really encouraged by those three facts, the kind of how we set on ACR and how that goes into a phase-free design, the safety profile, which is key, and then this aspect of of producing key inflammatory markers that could take this mechanism beyond RA.
00:07:50
Speaker
Great.
Regulatory Plans and Partnering for Phase 3
00:07:51
Speaker
And I believe that the the lack of overall immunosuppression, which you've seen, and and the significant reduction in CRP rates, it's it's actually quite key to the positioning of resomaligon. So moving ahead, Mads, how do these results influence your plans for the future development of resomaligon, including discussions with the regulators and the design for a potential phase three trials?
00:08:17
Speaker
Yeah, so so the next steps that that we're gonna take based on the ESLT trials or or that the advanced study. So we have what we need in terms of logic and data to support what kind of dosing should we do, what kind of duration of therapy should we expect, um and and obviously arguing for for how the safety profile works. So our next step is to go to the research plan for for you know end of Phase 2 meetings with FDA and EMEA.
00:08:54
Speaker
and we will work with our advisors on phase-free design based on this data and and really to move into the discussion with the authorities on on on on the move forward for development purpose. and then As I usually say, it's our our priority one, two and three is really on on finding right partners to do to to work with in terms of and a focusing on development and commercialization.
00:09:26
Speaker
And that is definitely also kickstarting now with with these these results because it really allows us or any partner coming into this, it allows them to say, okay, we can move this into Phase 3 with a ah profile that is is pretty clear um and that is a trigger for us to to engage. And we are are heavily on that track and we'll initiate that continue that already next week at the buyer international meeting in in San Diego, where we have a ah full calendar of events ahead of us.
Impact on Other Trials and Strategic Insights
00:10:06
Speaker
Excellent, and and we look forward to hearing more about that. And beyond ADVANCE, you also have another phase 2 trial ongoing RISP-PIA. So are there any important read-throughs from the ADVANCE study for the ongoing RISP-PIA study or CYNAC's overall ambitions in acute inflammatory indications?
00:10:28
Speaker
Yeah, so I think the the the best or the most important trigger here is really this, the reduction in the inflammation inflammation markers. um That is key to understand what this pro-resolution mechanism does in in with acute inflammation.
00:10:49
Speaker
um So it really, you know, it's it's a it's a very, very strong, and
00:10:57
Speaker
demonstration or evidence to suggest, you know, this has a role in in in these other diseases that we're looking for. The RESPIRE trial is running and we'll obviously have to see you how this pans out, especially in the setting of acute inflammation with patients coming into hospital due to viral infections or respiratory viral infections. um But the advanced study with the results on the reduction in inflammation markers is highly encouraging, not only to the ongoing viral infection studies, but also you know a lot of other arthritis indications that we we should be looking at um and a lot of other inflammatory instances that this this product might actually work in.
00:11:48
Speaker
That's
Strategic Options and Phase 3 Milestones
00:11:49
Speaker
great. And just to wrap up, how from a business development perspective, how do you see these results effects in a strategic options? And what are some of the milestones which investors should be watching out for over the next 12 months?
00:12:06
Speaker
Yeah, so so from a business development point of view, I think the logic really is a sound business logic, meaning that you have to, in rheumatoid arthritis, you have to see um you know and ACR scores in the level in translating into um a more durable ACR50 score.
00:12:34
Speaker
We already reached 39% in ACR50 of 12 weeks, and and there's no doubt that the full effect on ACR20 is going to be reached beyond week 12.
00:12:45
Speaker
So really bodes well for for a phase 3 design. So We think that for a durable ACR 50 and even ACR 70 response after 26 and 52 weeks is is what is is ah is what we should do and de demonstrate in a phase three. And that speaks to how physicians are looking at a and you know why should they use this compound?
00:13:12
Speaker
And also when speaking to U.S. payers, that's also the the primary thing is how can you take this patient population and treat them and really avoid them for escalating into biologic use? Because that's the big scare and from a payer point of view.
00:13:28
Speaker
um And I think what we are doing here is really setting ourselves on that path. And that's exactly the same path as any partner woods would look at from a business point of view. So the milestones based on that is obviously saying, how do we design a face-free program and how do we do that?
00:13:50
Speaker
We want to have a partner onboarded to... oh you know get into that into this this discussion as fast as possible. that i think that that would be the the most logical way of doing it.
00:14:02
Speaker
um ah And then um then the the the you know the development program will will outline you know clinical milestones of that. i think we're going to present this data as well on on major conferences with all the sub-analysis and things that we we take away from data
Conclusion and Future Presentations
00:14:22
Speaker
like this. And there's in a data set like this will will likely pop up with a lot of good insights along the way that will also fuel some of the you know the investor interest. Then obviously, Respire study and also what we're doing on the Dengue study is very interesting.
00:14:42
Speaker
Excellent. And thank you, Mads. And congratulations on the advanced study results. For our viewers interested in learning more about Synact Pharma, please visit edisongroup.com for our ongoing coverage of the company.
00:14:55
Speaker
Thank you. Thank you. Take care.