Company Overview - Relmada Therapeutics, Inc. is a late-stage biotechnology company focused on diseases of the central nervous system (CNS), particularly major depressive disorder (MDD) [6] - The company's lead program, REL-1017, is a new chemical entity (NCE) and a novel NMDA receptor (NMDAR) channel blocker designed to target hyperactive channels while maintaining physiological glutamatergic neurotransmission [6] Clinical Trial Results - The Reliance I study was a 28-day, Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 (75 mg on day 1, followed by 25 mg daily on days 2 through 28) as an adjunctive treatment for MDD [10] - The intent-to-treat (ITT) population included 227 randomized patients, while the per protocol (PP) population comprised 198 patients who completed treatment [10] - Although the primary endpoint was not met in the ITT analysis, REL-1017 demonstrated a statistically significant improvement in response rate compared to placebo (P = .044) and a nonsignificant trend for improvement in remission rate (P = .076) [5] - In post hoc analyses of patients with severe depression (MADRS score ≥35 at baseline), significant improvements were observed with REL-1017 versus placebo in both ITT and PP populations (MD CFB 6.9 and 7.9; P = .0059 and P = .0015; ES = 0.57 and 0.68, respectively) [5] Future Developments - Relmada is currently conducting two Phase 3 randomized, double-blind, placebo-controlled studies for REL-1017: Reliance II (Study 302) and Relight (Study 304), which share the same key study design parameters [5] - Top-line data from Reliance II is anticipated in the second half of 2024, with data from Relight expected approximately six months after the completion of Study 302 [12] Publication and Recognition - Clinical data from the Reliance I study has been published in the peer-reviewed journal, The Journal of Clinical Psychiatry, highlighting the efficacy and safety of esmethadone (REL-1017) in patients with MDD who have inadequate responses to standard antidepressants [9]
Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry