CORAL GABLES, Fla., June 18, 2024 /PRNewswire/ — Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the publication of REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, The Journal of Clinical Psychiatry. The article is titled, “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“, and is available online at Link To Title.
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“The overall results from this trial are clearly consistent with the evidence, produced by the prior phase 2 trial, for the efficacy, safety, and tolerability of esmethadone as a promising antidepressant for the adjunctive treatment of major depressive disorder. The side-effect profile of esmethadone compares quite favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.,” said Maurizio Fava, MD, the Principal Investigator of Reliance I.
Reliance I was a 28-day, Phase 3, randomized, double-blind, placebo-controlled study to evaluate REL-1017 (75 mg on day 1, followed by 25 mg daily on days 2 through 28) compared to placebo as adjunctive treatment in patients with major depressive disorder (MDD). The intent-to-treat (ITT) population comprised 227 randomized patients; the per protocol (PP) population comprised 198 patients completing treatment. The primary efficacy measure was 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.
As reported in December 2022, Reliance I did not meet the primary endpoint in the ITT analysis, yet, REL-1017 showed a statistically significant improvement in response rate compared to placebo (P = .044) and an encouraging nonsignificant trend for improvement in remission rate (P = .076). In the PP prespecified supportive analysis that excluded protocol noncompliant patients for reasons unrelated to REL-1017 adverse events (AE), results trended toward a more favorable outcome (MD CFB = 3.1; P =.051, ES = 0.29). Further, in post hoc analyses of patients with severe depression (MADRS score ≥35 at baseline), significant improvement as measured occurred with REL-1017 vs. placebo in both the ITT and PP populations (MD CFB 6.9 and 7.9; P =.0059 and P = .0015; ES = 0.57 and 0.68, respectively)
The side effect profile of REL-1017 was consistent with previous phase 1 and phase 2 studies of REL-1017, with no observations of treatment-related serious AEs and no observed signal for abuse potential and compares favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.
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). Relmada’s ongoing clinical research program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. The development program for REL-1017 as an adjunctive treatment for MDD includes two Phase 3 randomized, double-blind, placebo-controlled studies, Reliance II (Study 302) and Relight (Study 304). Reliance II and Relight have the same key study design parameters.
Relmada continues to enroll patients in both ongoing REL-1017 trials including Reliance II (Study 302), with top-line data anticipated in the second half of 2024, and Relight (Study 304) with top-line data anticipated approximately six months after the completion of Study 302.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada’s experienced and dedicated team is committed to making a difference in the lives of patients and their families. Relmada’s lead program, REL-1017, is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Learn more at www.relmada.com.