Relmada reports DMC assessment indicates Phase 3 Reliance II trial is futile

Relmada Therapeutics (RLMD) announced that the pre-planned interim analysis of Reliance II, conducted by the Independent Data Monitoring Committee, indicated that the Reliance II Phase 3 study is futile and is unlikely to meet the primary efficacy endpoint with statistical significance. Reliance II is designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder, to be used in combination with other approved anti-depressants. No new safety signals were reported. “We are disappointed with the outcome of this interim analysis,” said Sergio Traversa, CEO. “Based on these results, Relmada will evaluate the full dataset to determine next steps for the REL-1017 program. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study. We are grateful to the investigative sites and patients who participated in the REL-1017 program.”