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Relmada Therapeutics Announces Dosing of First Patient in Relight, a Phase 3 Trial of REL-1017 for the Adjunctive Treatment of Major Depressive Disorder
CORAL GABLES, Fla., Aug. 23, 2023 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"CORAL GABLES, Fla., Aug. 23, 2023 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the dosing of the first patient in the Relight (study 304) Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of Major Depressive Disorder (MDD).\n\n \n \n \n \n \n \n\n \n\"The dosing of the first patient in this important study represents a significant milestone in the ongoing late-stage development program of REL-1017 for the adjunctive treatment of MDD,\" said Cedric O'Gorman, Relmada's Chief Medical Officer. \"Relight has been designed to better control placebo response by reducing the time spent by patients at sites and to prioritize the quality of subject enrollment and overall data. Our recent investigator meetings with participating sites focused on providing intensive training on appropriate subject enrollment, data quality, strategies for controlling placebo response and rater training. We are confident that the optimized study protocol will enhance the potential for success in the Relight trial.\"\nThe Relight Phase 3 trial has a planned enrollment of approximately 300 patients. Relight is a randomized, double-blind, placebo-controlled, four-week trial, evaluating the efficacy and safety of REL-1017 as an adjunctive treatment of MDD in patients experiencing inadequate response to an ongoing background antidepressant treatment. The primary endpoint is the change in the MADRS total score from baseline to Day 28 for REL-1017 compared to placebo.\nThe Phase 3 development program for REL-1017 as an adjunctive treatment for MDD also includes the ongoing Reliance II (study 302) trial, which includes the same key study design parameters as Relight. Enrollment in the Reliance II study is expected to be completed in the first half of 2024. In addition, results from the recently completed Reliance-OLS (study 310), a long-term, open-label study of REL-1017 in MDD, are anticipated in the current quarter.\nThe Reliance and Relight Phase 3 clinical trials advance the clinical development of REL-1017 as an adjunctive treatment for MDD which, if approved, would be mechanistically different to treatments currently available for this indication.\nFurther information on the Relight Ph...