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Relmada Therapeutics Announces Completion of Treatment in Company's Registrational Phase 3 RELIANCE III Trial for REL-1017 as a Monotherapy for Major Depressive Disorder
CORAL GABLES, Fla., Sept. 20, 2022 /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., Sept. 20, 2022 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the completion of patient treatment in RELIANCE III, a monotherapy registrational Phase 3 trial evaluating REL-1017, the Company's novel NMDA receptor (NMDAR) channel blocker, for major depressive disorder (MDD). Relmada expects to report top-line data from the RELIANCE III trial early next quarter. \n\n \n \n \n \n \n \n\n \n\"We are pleased to continue to expeditiously advance our late-stage REL-1017 development program with the completion of treatment in RELIANCE III,\" said Sergio Traversa, Relmada's Chief Executive Officer. \"We have multiple significant catalysts anticipated over the next few quarters, beginning with top-line data from RELIANCE III, which is expected early next quarter. Based on REL-1017's product profile and the data generated from the Phase 2 study, we believe that REL-1017 has the potential to help address the substantial unmet need in MDD, a therapeutic area in which new treatment options are beginning to emerge after several decades of little innovation.\" The FDA has recently granted Fast Track Designation for REL-1017 as a monotherapy for the treatment of major depressive disorder.\nRelmada's late-stage development program for REL-1017 includes RELIANCE III, the Phase 3 two-arm, placebo-controlled registrational study for REL-1017 as a potential monotherapy treatment of MDD, as well as RELIANCE I and RELIANCE II, two ongoing Phase 3, two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment for MDD. The RELIANCE development program also includes Reliance-OLS, a long-term open-label safety study that is enrolling rollover participants from all three pivotal studies, as well as de novo participants.\nAbout REL-1017\nREL-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 treatment of major depressive disorder (MDD). The ongoing Reliance Clinical Research Program is designed to evaluate the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. ...