Relmada Therapeutics Halts REL-1017 Depression Trials, Explores Strategic Alternatives
Key Insights
Relmada Therapeutics discontinues Phase 3 trials (RELIANCE II and RELIGHT) of REL-1017 for depression (search) after unfavorable data monitoring committee evaluation.
The company will continue Phase 1 study of REL-P11, a psilocybin derivative, for treating metabolic diseases (search), shifting focus from CNS to metabolic disorders.
Relmada initiates strategic review, considering options like asset sales, mergers, or acquisitions to maximize shareholder value amid financial pressures.
Relmada Therapeutics Inc. (Nasdaq: RLMD) has announced the discontinuation of its RELIANCE II and RELIGHT Phase 3 studies of REL-1017, a treatment for depression (search). This decision follows an evaluation by the data monitoring committee (DMC) of the full dataset from the RELIANCE II study.
Strategic Shift
In light of this development, Relmada will now focus on advancing the Phase 1 study of REL-P11, an investigational agent for metabolic diseases (search). REL-P11 is a low-dose, modified-release formulation of psilocybin. The company acquired the development and commercial rights to the psilocybin program in July 2021, identifying its potential for treating metabolic disorders, with data presented at AASLD 2023.
Exploring Strategic Alternatives
Relmada has commenced a process to explore strategic alternatives to maximize shareholder value. These options include the potential sale of company assets, a sale of the company, a merger or reverse merger, the acquisition of assets or rights for the development of other products, or other strategic transactions. The company is engaging a financial advisor to assist in this process.
About REL-1017
REL-1017 is described as a new chemical entity (NCE) and a novel NMDA receptor (search) (NMDAR) channel blocker. It is designed to preferentially target hyperactive channels while maintaining physiological glutamatergic neurotransmission.
Financial Context
The decision to discontinue the Phase 3 trials comes amid financial pressures. As of September 30, Relmada reported an accumulated deficit of $622.2 million with $54.1 million in cash remaining, with warnings of insufficient liquidity to sustain operations through one year.
Relmada has not set a timetable for the completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless it is determined that further disclosure is appropriate or necessary.