Relmada Therapeutics, Inc. (RLMD) announced Monday that it will discontinue the Reliance II and Relight Phase 3 studies in light of the recent data monitoring committee or DMC evaluation of the full dataset from the Reliance II Phase 3 study of the company's REL-1017 program.
Relmada further announced that it has commenced a process to explore strategic alternatives, including a sale, sale of company assets, and a merger or a reverse merger, among others. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such deals.
The company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study.
The Phase 3 Reliance II trial was designed to evaluate REL-1017 as an adjunctive treatment for major depressive disorder or MDD, to be used in combination with other approved anti-depressants.
DMC, which conducted the interim analysis, last week found that the trial was unlikely to meet the primary efficacy endpoint with statistical significance. Following the news, shares of Relmada had plunged sharply.
REL-1017 is a new chemical entity or NCE and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission.
Relmada acquired the development and commercial rights to a novel psilocybin and derivatives program in July of 2021.
The late-stage biotechnology company now said it is in the process of engaging a financial advisor to assist in the strategic review process.
In pre-market activity on the Nasdaq, the shares were gaining around 2.23%.
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