Relmada Therapeutics (RLMD) has been working on a new MDD drug (major depressive disorder) known as REL-1017, an NMDA (NMDAR) channel blocker. The company released top-line results on Thursday October 13th. The top line results revealed that the drug showed to be effective (-14.9 reduction from baseline), but the placebo group also displayed a reduction in depressive symptoms (-13.9 from baseline) on the MADRS 10 Total Score. The .9 differential between the two groups at day 28 was deemed to be a clinical trial failure.
The company did a secondary clinical trial analysis, and determined that when excluding clinical sites with implausibly high or low placebo responses (4-5 of the total sites), showed a meaningful difference between REL-1017 and placebo to the effect of 4.9 points on the MADRS 10 versus placebo p=0.05.
Based on the results above, Relmada may have to run another phase 3 clinical trial for MDD to proceed to an NDA filing. The timeline to starting and completing would be around one year based on this just completed clinical trial, then filing an NDA would require additional time. Most likely to get REL-1017 approved for MDD, could take two years from the start of an additional clinical phase 3 MDD trial to FDA approval, if everything goes well. Note that Relmada does not have Breakthrough Therapy Designation (BTD) for REL-1017, MDD.
Axsome Therapeutics Auvelity, was just granted FDA approval for MDD in August 2022, with a planned launch early 4th quarter 2022. Auvelity, provides a fast-acting oral anti depressant therapy. REL-1017 would have competed directly with Axsome's Auvelity, as both provide a fast acting response, which is an unmet need to current MDD drugs on the market. Axsome's stock had an upward response after the Relmada results were revealed, while Relmada chart below, sold off.
