Relmada Therapeutics will halt two Phase III trials of a major depressive disorder drug after a futility assessment and explore strategic alternatives including a potential sale to maximize shareholder value.
News foreshadowed by Relmada last week came to fruition Monday as the company announced it would discontinue studies of depression drug REL-1017 after an independent Data Monitoring Committee determined it was unlikely to succeed.
Relmada announced on Dec. 4 that a preplanned interim analysis of the Phase III Reliance II study indicated it was futile and unlikely to meet the primary efficacy endpoint with statistical significance. The biotech has also halted the Phase III Relight study of REL-1017 in major depressive disorder (MDD).
The news hit Relmada hard. Its stock crashed more than 70% in premarket trading on Dec. 4, according to Endpoints News. And on Monday, the company said in a press release it would explore strategic alternatives to maximize shareholder value. These could include “the sale of company assets, a sale of the company, a merger or a reverse merger, the acquisition of assets or rights for the development of other products, or other strategic transaction(s).”
REL-1017, an NMDA receptor channel blocker designed to be given in combination with other antidepressants, previously missed the primary endpoint in the Phase III RELIANCE III study in October 2022. The candidate was unable to show a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale.
Relmada will continue to advance REL-P11, a novel modified release psilocybin formulation currently in a Phase I study, for metabolic disease, according to Monday’s press release.
The failure of REL-1017 is more bad news for MDD patients and drug developers as it comes on the heels of Alto Neuroscience’s Phase II miss with ALTO-100, which failed to improve symptoms of MDD in October. This news came just nine months after Alto’s $128.6 million IPO in February and caused the biotech’s stock to plummet 60%—another example of just how difficult drug development in this space can be.
