Relmada announces results from Phase 3 study of REL-1017

Relmada Therapeutics announced efficacy results for the de novo patients and safety results for all subjects from the Phase 3, long-term, open-label, registrational trial, or Study 310, of REL-1017 in patients with Major Depressive Disorder, or MDD. Detailed efficacy data for rollover population in the study will be presented when available. Patients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment. REL-1017 was well-tolerated with long-term dosing, showing low rates of adverse events and discontinuations due to adverse events. No new safety signals were detected. Study REL-1017-310 was a long-term, open-label, non-comparative, registrational Phase 3 trial designed to evaluate the efficacy and safety of REL-1017 administered once-daily in patients with MDD for up to one year. In total, 627 patients were enrolled, comprising 423 patients who rolled over from placebo-controlled trials with REL-1017, and 204 de novo patients who had not previously participated in trials with REL-1017. The trial was concluded when at least 300 patients had been treated for six months and approximately 100 patients had been treated for 12 months. At the time of study conclusion, 418 patients had reached at least six months of treatment, and 118 patients had reached at least 12 months of treatment. When treated with REL-1017, 26.6% of de novo patients achieved clinical response by Day 7, 51.0% by Month 1, 60.7% by Month 3, 63.4% by Month 6, and 77.2% by Month 12. Clinical response is defined as a greater than or equal to50% improvement in MADRS total score.