Results from Phase 1 and 2 studies fueled the progression of REL-1017 to registration
trials for major depressive disorder (MDD).
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. 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.
We are rapidly advancing programs for both adjunctive and monotherapy treatment of MDD because of the unmet need that remains and the promise of this potential therapy.
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.
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.