Relmada Therapeutics, Inc. announced the dosing of the first patient in the Relight (study 304) Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of Major Depressive Disorder (MDD). The Relight Phase 3 trial has a planned enrollment of approximately 300 patients. Relight is a randomized, double-blind, randomized, double-blind), placebo-controlled, four-week trial, evaluating 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 to placebo. The Phase 3 development program for REL-1017 as an investigational treatment for MDD also includes the ongoing Reliance II (study 302) 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 (study 310), a long-term, open-label study of REL-1017 in MDD, are anticipated in the current quarter. The Reliance and Relight Phase 3 clinical trials advance the clinical development of REL-1017 as a adjunctive treatment for MDD which, if approved, would be mechanistically different to treatments currently available for this indication. About REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the adjunctive treatment of major depressive disorder (MDD).

The ongoing Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment.