Results from phase 1 and 2 studies fuel the progression of REL-1017 to registration trials for major depressive disorder (MDD).
Our lead program, REL-1017, an NMDAR channel blocker with a preference for pathologically hyperactive channels, is in development for the adjunctive treatment of major depressive disorder. 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 has granted Fast Track designation for REL-1017 as an adjunctive treatment of major depressive disorder.
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 U.S. Food and Drug Administration on the primary components of its planned Phase 3 program of REL-1017 for adjunctive treatment of MDD and intends to initiate the first pivotal trial in the second half of 2020. Plans for a Phase 2 program for the clinical development of REL-1017 as a monotherapy agent 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.