Relmada Exploring ‘Strategic Options’ Following Setback with Depression Treatment Asset

Relmada Therapeutics confirmed on Monday what many had anticipated after a previous announcement: the discontinuation of their depression medication REL-1017. This decision follows an independent Data Monitoring Committee’s assessment, which expressed that the trials were unlikely to succeed.

On December 4, Relmada revealed that a scheduled interim analysis of the Phase III Reliance II study revealed it to be futile, with concerns raised about its potential to meet primary efficacy endpoints with statistical significance. They also decided to cease the Phase III Relight study of REL-1017 aimed at treating major depressive disorder (MDD).

The news caused a drastic decline for Relmada, with its stock plummeting over 70% in premarket trading on December 4, as reported by Endpoints News. In light of these developments, the company communicated in a press release that it would pursue strategic alternatives to enhance shareholder value. These options may consist of “the sale of company assets, a complete company sale, a merger or reverse merger, acquisition of assets or rights for further product development, or other strategic transactions.”

REL-1017, which functions as an NMDA receptor channel blocker and is intended to be combined with other antidepressants, had previously missed the primary endpoint in the Phase III RELIANCE III trial back in October 2022. It failed to demonstrate a statistically significant benefit in alleviating depression symptoms when compared to a placebo, based on the Montgomery-Asberg Depression Rating Scale.

Despite the setback with REL-1017, Relmada intends to move forward with REL-P11, a new modified release psilocybin formulation that is currently undergoing a Phase I trial targeting metabolic disorders, as per the latest press release.

This failure of REL-1017 adds to the woes of both patients suffering from MDD and companies in this sector, particularly in light of Alto Neuroscience’s Phase II miss with ALTO-100, which did not yield improvements for MDD patients in October. This setback came just nine months following Alto’s impressive 8.6 million IPO in February, leading to a massive 60% drop in the company’s stock—emphasizing the challenging landscape of drug development in this field.