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Relmada Therapeutics Announces Top-line Results from Phase 3 RELIANCE III Trial for REL-1017 as a Monotherapy for the Treatment of Major Depressive Disorder
RELIANCE I and II Adjunctive MDD Trials Continue to Advance CORAL GABLES, Fla., Oct. 13, 2022 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"RELIANCE I and II Adjunctive MDD Trials Continue to Advance\nCORAL GABLES, Fla., Oct. 13, 2022 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD), did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) on Day 28. In the study, the REL-1017 treatment arm showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher than expected placebo response. Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017. Relmada is investigating the nature of these results.\n\n \n \n \n \n \n \n\n \nREL-1017, which was administered for 28 days to 232 subjects in RELIANCE III, demonstrated very favorable tolerability and safety, confirming the results of Phase 1 and Phase 2 studies (Fava et al, 2022)¹, with no opioid-like effects, no withdrawal effects, and no psychotomimetic effects. There were no adverse events related to QTcF prolongation.\n\"While these RELIANCE III results are disappointing for patients, the need for new, safe and effective treatments for MDD continues to exist. We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD.\" said Maurizio Fava, Psychiatrist-In-Chief, Massachusetts General Hospital and Slater Family Professor of Psychiatry, Harvard Medical School.\nTo better understand the paradoxical results, a post-hoc, exploratory analysis using the band-pass method (Merlo-Pich et al, 2010²) was conducted. The band-pass analysis excludes sites with implausibly high or low placebo responses (defined as a mean decrease from baseline in MADRS10 score greater than 14 and less than 3 points) and showed a meaningful difference between REL-1017 and placebo (>4.9 points on the MADRS, p","length":3086,"tagName":"div"}]