Mineralys Therapeutics, Inc. (NASDAQ:MLYS) Q3 2023 Earnings Call Transcript

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Let me give you two examples. So one sort of unanticipated thing was we put people on a very rigorous regimen, and it includes a diuretic called Indapamide. Now Indapamide is somewhat like Chlorthalidone. It’s very potent. It’s not often used, even though it’s admittedly or I guess the consensus is it’s probably the most powerful one. And what we found was that so many people were actually on hydrochlorothiazide and they didn’t want to stop it and neither did their doctors, that that was the sole reason why they didn’t wanna be screened and entered in the trial. And so one of the learnings we have was that if we just allow people to use the maximum tolerated dose of hydrochlorothiazide, we could fairly significantly increase the number of people who are willing to be screened to go in the trial.

So that’s one change we made, easy to understand simple, and it should have a pretty positive effect. Now if you look at the next gate here if you will, we put everybody on this very powerful regimen and quite a few people, even though they were on what looked like an okay regimen, their hypertension comes under control with these easily prescribed medications. Now the other thing we do, by the way, is we do real time adherence monitoring. So everybody has to take their drug or we know it in real time. Between adherence and a better regimen, we lose a lot of people because they become under control, but what we noticed was if they start out with a blood pressure historically of over a 145 millimeters of mercury systolic, then they had a much higher prevalence of still having hypertension and getting randomized into the trial.

So that’s the second thing we’ve done, which is to provide a guidance to our sites, to start screening prescreening the records for people whose blood pressures are on the higher side and only put them into the screening and stabilization, standard regimen protocol. Those are just two examples. There are others, but those are pretty easy to understand, and we expect that to have a fairly strong effect on increasing our screening and randomization rate. Oh, yeah. You wanted to know about Launch. I forgot. Let me answer your last question, Colleen. I’m sorry. Real quickly, the Launch trial is designed to be a validation essentially a confirmatory trial for Target-HTN. So we’re trying to keep it as close to Target-HTN as possible. We have a really good database there on this, the inclusion, exclusion criteria screening, and randomization, probabilities there.

So we we’re using a few of the learnings, but we don’t expect that trial to have the same spectrum of challenges that we’re seeing in and – and handling now in the Advanced trial.

Operator: Thank you. Your next question is from Mohit Bansal from Wells Fargo. Please ask your question.

Mohit Bansal: Hi. This is Serena on for Mohit. Thanks for taking our question. Wanted to ask about CKD and how you’re thinking about whether lorundrostat would be best combined with diuretics to maximize reduction of pressure on the kidneys or SGLT2s, which would confer kidney benefits beyond the impact on blood pressure?

David Rodman: Oh, this is Dave again. Thanks for that question. It’s – it’s complicated, right? What drugs should they be on? But the standard of care right now is for everybody to be on an ACE or an ARB and a diuretic, often a thiazide, but sometimes a loop diuretic. So those things are sort of a given. They’re gonna be used and so our treatment would be add on to that. Right now, SGLT2s are approved and known to be effective, but they’re pretty expensive and access is still kind of limited. So the percentage of people on an SGLT2 is somewhat less. So, but we anticipate by the time we launch, they’ll be much more prevalent and also in standard of care. So the trial we’re running will have people either on all three of those or just on the ACE or an ARB and diuretics.

So we’ll be able to answer your question with data at that point. And we’re looking forward to seeing those data at that point. One thing I will mention though is the SGLT2s lower your serum potassium and so there is an advantage to that combination, because you have even less of a hyperkalemia risk, although we haven’t really seen that as a problem yet with lorundrostat. Was there a second part to your question? No?

Mohit Bansal: Nope. Thank you so much.

David Rodman: Yeah. You’re welcome.

Jon Congleton: Thanks, Serena.

Operator: Thank you. There are no further questions at this time. I will now hand the call back to Jon Congleton for the closing remarks.

Jon Congleton: Thank you, operator, and thank you to everyone for joining us today. We’re very excited about the progress we’ve made thus far in 2023 and advancing our clinical programs and we remain enthusiastic about the upcoming milestones for the rest of the year and into 2024. We look forward to updating you as our pivotal program for lorundrostat continues to advance. With that, we’ll close the call. Thank you.

Operator: Thank you. [Operator Closing Remarks].

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