Relmada Therapeutics, Inc., a late-stage biotech company addressing diseases of the central nervous system (CNS), has been given U.S. Food and Drug Administration (FDA) Fast Track designation to REL-1017, the company’s novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment of major depressive disorder (MDD).
“The receipt of Fast Track Designation represents a significant milestone for our promising late-stage REL-1017 development program,” said Paolo Manfredi, the company’s chief scientific officer.
“This designation further supports the potential of REL-1017 as a paradigm shifting novel stand-alone treatment for MDD and highlights the significant unmet medical need in a therapeutic area where little has changed over the last several decades: available treatments remain inadequate for the majority of patients with MDD. We thank the FDA for this designation and we will continue to work closely with the Agency to bring this much needed potential new therapy to patients as expeditiously as possible.”
Relmada’s late-stage development program for REL-1017 includes Reliance III, an ongoing monotherapy registrational phase 3 trial. In addition, Reliance I and Reliance II are two ongoing phase 3 sister two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment for MDD.
The Reliance development program also includes Reliance-OLS, the long-term open-label safety study that is enrolling rollover participants from all three pivotal studies, as well as new participants.
REL-1017, a new chemical entity and NMDAR channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of MDD.
The ongoing Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment.
In a phase 2 trial, REL-1017 demonstrated rapid, robust, and sustained antidepressant effects with statistically significant improvements compared to placebo. The phase 2 study also showed a favorable pharmacokinetic, safety, and tolerability profile of REL-1017 consistent with results observed in previously completed phase 1 studies.