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Our lead program, REL-1017, an NCE and novel NMDAR channel blocker with a preference for hyperactive channels associated with MDD, has entered its Phase 3 registration program as an adjunctive treatment for MDD and a Phase 3 program as a monotherapy treatment for MDD. Data from the Phase 2 trial with REL-1017 suggest rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. Safety and tolerability results in the Phase 2 study were also consistent with those reported in previously reported Phase 1 studies. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for REL-1017 as an adjunctive treatment of MDD.
Relmada has reached alignment with the FDA on the primary components of its Phase 3 program of REL-1017 for adjunctive treatment of MDD: Two pivotal, randomized, placebo-controlled studies, Reliance I and Reliance II, and a long-term, open-label study, Reliance-OLS. Reliance I, the first pivotal trial, was initiated in December 2020, and Relmada announced that Reliance II and Reliance-OLS were underway in April 2021. Plans for the clinical development of REL-1017 as a monotherapy are also underway in Reliance III: A Phase 3, randomized, placebo-controlled study. If you are a physician or person living with depression who would like to learn more about the Reliance program, please contact: email@example.com
We believe there is a real potential for REL-1017, as a once-daily, oral option, to treat major depressive disorder safely, effectively, and more quickly than is currently possible, potentially changing the current the standard of care.
The clinical program with REL-1017 suggests a potentially differentiated profile in terms of safety, efficacy, tolerability and onset of action. Visit our Data and publications page to learn more about REL-1017 and the clinical data to date.