Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q1 2024 Earnings Call Transcript

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It’s a short study. So the old study will last like three, four months maximum.

Andrew Tsai: Thanks a lot, thank you.

Sergio Traversa: Thank you.

Operator: [Operator Instructions] Your next question comes from Louis or from Brazil. Please go ahead.

Unidentified Analyst: Hi. I this is Charles on for [indiscernible] My question about kind of the screening failure rate and if you think that’s going to kind of stay at 80 throughout this study enrollment? And then also, if you could clarify if on Reliance II screening failure rate was also 50% before the new protocol? Thank you.

Sergio Traversa: Hey, charlie, thanks for the question. And then so the screening failure is high, but we look at the reason for the screening failure and they are legitimate reasons. It usually is drug-drug interaction for concomitant, mostly its concomitant medication. So these are legitimate reasons not to enroll in the study and most of this still, the screening failures actually come from the site. And with that said, we are in constantly review and we listen very carefully to the feedback from the sites and there is anything that we can do to increase the enrollment rate or decrease the screening failure, but without decreasing the quality and an increase in the risk of the trial, we have been doing that. So there are certain things that have been they especially want the drug-drug interaction that they or concomitant medication more than interaction that that have been have been changing over time.

So that should facilitate. And this is a back and forth from the company and the site. So they give us feedback and we see patient with that characteristic that it’s a good fit into the trial, but we cannot put it in because of the inclusion-exclusion. So we revised and in a dialogue with the FDA, of course, we have made a few like detailed revision of the product over time. So we don’t know what we’ll do to the screening failure, but definitely there is a chance that we could get a little better. And the second question was at the beginning because that’s a great question, but I don’t have the answer on the top of my head and they had a screening failure on the beginning of 302. Probably there are not like a lot of patients enrolled, so I don’t know how much that number is meaningful, but maybe Andy or Maged, if they have some more color on that in the screening failure on the study 302 before we amended the protocol?

Maged Shenouda: I don’t believe it was like…

Andrew Cutler: Yes, go head Maged, sorry.

Maged Shenouda: Go ahead, Andy.

Andrew Cutler: Yes, it was certainly not quite as high. I don’t want to put a number out there without confirming with our internal team. So, we’ll have to get back to you soon.

Maged Shenouda: Yes, exactly. But I would not be put off by saying so we’re trying to find the right patients and that’s critically important. Patient selection is absolutely a source of failure in studies.

Unidentified Analyst: Okay.

Sergio Traversa: And yes, as we mentioned in some of our calls, one of the biggest change in the amendment we made to the protocol is that there is now a requirement for medical and pharmacy records, and that’s by itself increase the screening failure. But also at the same time, you are relatively comfortable that that patient comes from like from a doctor that has diagnosed and prescribed medication and that the patient purchased the medication from the pharmacy. So the two things they go together, high screening and failure. But yes, there is clearly an improvement in the risk profile of the patients enrolled. I hope that answers your question.

Unidentified Analyst: Yes, thank you.

Operator: There are no further questions at this time. I’ll turn it back to Sergio for closing remarks.

Sergio Traversa: Thank you. And in summary, we continue to firmly believe that we have an approvable drug in REL-1017 and we are excited by the potential of our novel psilocybin derivative program. We look forward to reporting further progress with our pipeline throughout the remainder of 2024. I do remain grateful to the Relmada team for their continued hard work and dedication to executing on our mission. Also, as always, I would like to extend my sincere thanks to the patients and clinical partners involved in the REL-1017 trials for their participation in the advancement of this promising investigational medicine through development. Thanks a lot to everyone for the attention and the interest and looking forward to the next conference call.

Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

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