Relmada Therapeutics Publishes Phase 3 REL-1017 Study Results in Clinical Psychiatry Journal

June 18, 2024-- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company focusing on central nervous system (CNS) disorders, has announced the publication of clinical data for REL-1017 from the Reliance I Study. The data has been featured in The Journal of Clinical Psychiatry under the title, "Efficacy and Safety of Esmethadone (REL-1017) in Patients with Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial."

Maurizio Fava, MD, Principal Investigator of Reliance I, commented that the results are consistent with previous phase 2 trials, showcasing the efficacy, safety, and tolerability of esmethadone as a promising antidepressant for major depressive disorder (MDD). He noted that esmethadone's side effects are favorable compared to other FDA-approved MDD treatments.

Reliance I was a 28-day, Phase 3, randomized, double-blind, placebo-controlled study. It tested REL-1017 (75 mg on day 1, then 25 mg daily for the next 27 days) against a placebo in patients with MDD. The study's intent-to-treat (ITT) population included 227 randomized patients, while the per protocol (PP) population included 198 patients who completed the treatment. The main efficacy measure was the mean difference (MD) between REL-1017 and placebo in change from baseline (CFB) through day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score.

Although the primary endpoint was not met in the ITT analysis, REL-1017 showed a statistically significant improvement in the response rate compared to placebo and an encouraging trend in remission rates. In the PP supportive analysis excluding protocol noncompliant patients, results were more favorable. Further post hoc analyses revealed significant improvement in severely depressed patients with baseline MADRS scores of 35 or higher.

The side effect profile of REL-1017 was aligned with previous studies, showing no treatment-related serious adverse events or signal for abuse potential. This profile compares positively to existing FDA-approved adjunctive treatments for MDD.

REL-1017 is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining normal glutamatergic neurotransmission. Currently in late-stage development, REL-1017 is being tested as an adjunctive treatment for MDD. Relmada's clinical research program aims to develop REL-1017 as a rapid-acting, oral, once-daily antidepressant.

The program includes two Phase 3 studies: Reliance II (Study 302) and Relight (Study 304), both featuring similar design parameters. Patient enrollment continues for both studies, with top-line data from Reliance II expected in the second half of 2024 and data from Relight anticipated approximately six months later.

Relmada Therapeutics, Inc. is dedicated to addressing CNS disorders, particularly major depressive disorder. Their experienced team strives to improve the lives of patients and their families. The lead program, REL-1017, focuses on being an adjunctive treatment for MDD in adults.

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