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| Statement |
|---|
| We're very optimistic about the broad potential of ATI-450 and very eager to complete and report on the current clinical trials |
| Overall to date, we are very pleased with the safety profile we see with ATI-450 through the current stage of clinical development |
| We do think that expanding the enrollment criteria to mild is going to certainly enhance the uptick in terms of recruitment, and we're confident in terms of the time lines that we issued today |
| There is tremendous opportunity for significant creation of shareholder value in this space, and we find ourselves in the enviable position of having several key clinical stage assets targeting these potential diseases led by our potential first-in-class MK2 inhibitors zunsemetinib or ATI-450 |
| So I think we're in good shape |
| Overall, I'm very pleased with the performance of our company through this first quarter of 2023 |
| Our team is making tremendous progress, advancing all of our various clinical development programs, which is a testament to our team as we are a relatively small company in terms of size and overhead |
| I also remain impressed with their team's ability to continue to execute global clinical trials in a challenging macro environment that is continually taxed by economic downturn, choked supply chains and global conflicts |
| However, we've recently seen good momentum in screening and enrollment from our Polish sites |
| Overall, despite various hurdles, I am very pleased with the professionalism of our development team as well as all of our various partners and trial sites and the commitment of so many physicians and patients |
| But so far, it's tracking to be -- to have an extremely attractive and we think competitive safety profile |
| So we're very bullish in terms of what all that means in terms of the RA study that's going to read out in the fourth quarter of this year |
| I'm very pleased with the quality and execution of our entire team here at Aclaris |
| The conference team continues to deliver unique and novel potential medicines against targets addressing significant unmet medical needs |
| Importantly, ATI-1777 was observed to have a favorable safety and tolerability profile and because of the soft topical approach, very low plasma levels of ATI-1777 were seen following the topical application with the average concentrations in patients never greater than 5% of the IC50 of JAK1/3, and only three patients had concentrations greater than 1/10 of the IC50 |
| And in terms of the -- I understand this -- the CPK elevation transient and the kind of sales results, and it's very good, you don't have the symptoms associated |
| We've been very encouraged by the success seen recently with other topical therapies in a broader array of patients and the meaningful medical need in some milder patients |
| So I think we achieved that |
| We think that mechanistically ATI 238 looks very attractive in the indications that we're seeking UC initially and a whole bunch of other T cell diseases subsequently, and we'll see how the market evolves |
| We are quite proud that we enrolled a trial that was very representative of real-world HS patient populations with more inclusion of historically underrepresented people |
| The multiple ascending dose study in healthy volunteers continues to progress well |
| As a reminder, our company already had positive proof-of-concept data in array from a prior Phase 2a trial |
| Building on the successes of the ATI-2138 single ascending dose study |
| Suffice it to say that placebo had a very good day on basically every endpoint |
| So we have significantly more confidence in the safety profile of the drug and there's really no red flags |
| In fact, placebo did better in this study than active did in some of the more successful Phase 3 studies that have already been published |
| We've seen quite an uptick in enrollment just in the last few months as we've been able to get through regulatory hurdles with the Polish government |
| I'm pleased to let you know that we are in the later stages in terms of enrollment for the rheumatoid arthritis Phase 2b trial, and everything is very much on track |
| Although we were disappointed that the efficacy results were not what we had hoped for in this challenging and still relatively misunderstood disease, our team delivered on time a well-executed trial |
| Despite all these headwinds, our team is continuing to prosecute these studies and demonstrating creativity and flexibility in the face of hurdles when they arise |
| Statement |
|---|
| This protocol modification is also important because as some of you may have seen reported from other companies conducting trials in atopic dermatitis, enrollment this past winter season have encountered some challenges, particularly driven by the mild winter in many locations, particularly in the southern and eastern portions of the US |
| that we're doing the AD Phase 2b study, which is mostly in the Northeast and the Southeast, in fact, it was a very mild winter, and we and everybody else we're seeing slowed enrollment |
| So it isn't for a lack of enthusiasm, but there are some headwinds in that part of the world that we're dealing with |
| Based on some of the tensions in the region surrounding Ukraine, it took a little bit longer than anticipated for site activations |
| What we did see, unsurprisingly, given the lack of efficacy is a meaningful number of early discontinuations from treatment shown on slide 13 |
| And you know if your blood pressure goes up and stays up that, that can cause harm |
| Withdrawals due to loss to follow-up, withdrawal of consent, and investigator stated lack of efficacy were relatively balanced between the ATI-450 and the placebo-treated arms |
| But the CPK issue, for lack of a better word, in our clinical trials has been a bit of a nothingburger for investigators |
| There was a challenge in the part of the world with Ukraine and then with many, many companies switching over to having more studies in Poland |
| We saw a modest effect, which was overshadowed by an unusually large placebo effect |
| And for that, I could not be more proud |
| It's a little ironic for people who live in the west part of the country because we had a very, very snowy winter |
| We took a shot at a very difficult disease in HS knowing that we already had positive RA data in hand |
| Since the dryness associated with cold winter weather and heating can exacerbate atopic dermatitis |
| So I think one of the things to just recognize is, while not necessarily covered in the label because it doesn't seem to be a safety concern at all |
| And as such, that patient has been removed from that category, which brings the percentage down below the 10% threshold that we reported |
| The adverse event profile has continued to be as expected |
| What might be possible to reaccelerate enrollment in the zumsemeinib psoriatic arthritis trial? Douglas Manion And just to point out, it is a difficult part of the world to be doing these types of studies |
| As previously noted, the study did not demonstrate efficacy for ATI-450 in the treatment of HS |
| Regarding our financial performance for the quarter, our net loss was $28.2 million for the first quarter of 2023 compared to $18.8 million during the first quarter of 2022 |
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