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Relmada Therapeutics Announces Initiation of Second Pivotal Phase 3 Study of REL-1017 as Adjunctive Treatment for Patients with Major Depressive Disorder
Long-Term Safety Study Also Underway Top-line Data from Both Pivotal Studies Expected in First Half of 2022 NEW YORK, April 1, 2021 /PRNewswire/ -- Relmada
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"Long-Term Safety Study Also Underway\n Top-line Data from Both Pivotal Studies Expected in First Half of 2022\n\n\nNEW YORK, April 1, 2021 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the initiation of the second of the two sister pivotal Phase 3 clinical trials (RELIANCE I and RELIANCE II) for the Company's lead product candidate, REL-1017, as an adjunctive treatment for major depressive disorder (MDD).\n\n \n \n \n \n \n \n\n \n\"We are pleased to begin enrolling patients into the second Phase 3 clinical trial of REL-1017 in MDD, a condition impacting more than 17 million individuals in the U.S., with limited safe and effective therapeutic options currently available,\" said Sergio Traversa, Relmada's Chief Executive Officer. \"The first Phase 3 trial, RELIANCE I, which was initiated in December 2020, continues to enroll patients as planned, and additional sites are coming online. Importantly, the pivotal Phase 3 studies in the RELIANCE program are optimized to reduce the risk of placebo effect associated with depression trials due to the two-arm design, strong focus on site selection and training as well as the multiple levels of screening to ensure accurate patient diagnosis. We continue to anticipate the availability of top-line data from RELIANCE I and RELIANCE II in the first half of 2022.\"\nThe company also confirmed that RELIANCE-OLS, the long-term, open-label safety study for REL-1017, is underway. RELIANCE-OLS will include both patients continuing from the pivotal studies as well as de novo patients. \nKey Aspects of the RELIANCE Clinical Studies Program for REL-1017 in MDD: \nThe Phase 3 program consists of two sister, two-arm, placebo-controlled clinical trials, RELIANCE I and RELIANCE II. Each trial will be conducted at up to 55 clinical sites in the United States and will include 364 MDD patients with inadequate response to one up to three standard antidepressants in their current depression episode. Patients will add either a 25 mg oral dose of REL-1017 or placebo once per day to their ongoing antidepressant treatment. The primary endpoint is the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) score, a well-established measure of the severity of depression, a...