Relmada Therapeutics (NASDAQ:RLMD) announced dosing the first patient in the Relight Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of major depressive disorder (MDD).
The Relight four week Phase 3 trial has a planned enrollment of approximately 300 patients to evaluate the efficacy and safety of REL-1017 as an adjunctive treatment of MDD in patients experiencing inadequate response to an ongoing background antidepressant treatment.
The primary endpoint is the change in the MADRS total score from baseline to day 28 for REL-1017, compared with placebo.
The Phase 3 development program also includes the ongoing Reliance II trial, which includes the same key study design parameters as Relight. Enrollment in the Reliance II study is expected to be completed in the first half of 2024.
In addition, results from the recently completed Reliance-OLS, a long-term, open-label study of REL-1017 in MDD, are anticipated in the current quarter.
