Relmada Therapeutics (RLMD) Jefferies 2024 Global Healthcare Conference summary

Program overview and drug profile

• REL-1017 is a once-daily oral NMDA antagonist developed as adjunctive treatment for depression, targeting patients unresponsive to SSRIs or SNRIs.

• Phase I and II trials showed strong efficacy and safety; two initial phase III trials during COVID-19 had mixed results due to high placebo response.

• No serious side effects observed in over 1,500 patients; main side effect is transient nausea at high doses.

• Market opportunity estimated at 4–5 million patients in the US for adjunctive depression treatment.

Clinical development and trial improvements

• All required phase I studies, including special populations and abuse potential, are complete; only two positive phase III trials are needed for NDA filing.

• COVID-19 impacted prior phase III trials, leading to high placebo response and less reliable patient selection.

• Current phase III trials feature improved protocol, rigorous patient adjudication, and optimized site selection based on prior data.

• Patient enrollment now requires verifiable medical and pharmacy records to ensure true biological depression.

Trial operations and monitoring

• Data cleaning is performed in real time; first phase III data expected in the second half of this year, with the second study about six months behind.

• Dropout rates remain low at about 6%, and screen failure rates have increased to 75–80% due to stricter patient selection.

• Enrollment is spread across sites to avoid outlier effects, and site quality is closely monitored with regular visits.

• DMC will conduct an interim sample size re-estimation at 75–80% enrollment, with results to be shared publicly.