After a data monitoring committee found that one of Relmada Therapeutics' late-stage trials in major depressive disorder (MDD) would likely miss its main goal, the biotech has scrapped two phase 3 trials and is considering a range of strategic options.
The biotech is now exploring several different paths, including a merger or reverse merger, buying or selling assets, or selling the company entirely, according to a Dec. 9 release. Relmada hasn't set a timeline for when it might make a move if it chooses to do so, the company said.
Last week, the biotech revealed that its phase 3 trial, dubbed RELIANCE II, was unlikely to meet the study's primary endpoint assessing the efficacy of REL-1017 as an adjunctive treatment for patients with MDD. REL-101 is an oral tablet designed to block hyperactive NMDA receptor channels, which are linked to MDD and other central nervous system disorders. The compound is also called esmethadone and is part of methadone, the pain and substance use medication.
Relmada is now scrapping RELIANCE II, plus another phase 3 trial called Relight, which was assessing REL-1017 as an add-on treatment for patients with MDD who didn't respond to other antidepressant treatment. RELIANCE II and Relight have the same general design and have an estimated 340 patients enrolled in each.
The biotech's stock has remained largely unchanged today but has plummeted 85% since Dec. 4, when Relmada announced the likely phase 3 miss.
RELIANCE II is the third strike for REL-1017, which has already flamed out in two other phase 3 trials, RELIANCE I and RELIANCE III.
In October 2022, REL-1017 flopped as a monotherapy in RELIANCE III—a phase 3 MDD trial—failing to outperform placebo in reducing depression symptoms. When another flop followed several months later, this time as an adjunctive MDD treatment in RELIANCE I, Relmada blamed “a limited number of high enrolling sites with unplausible placebo response.”
Relmada tried to bounce back with 2023 open-label data that showed REL-1017 improved depression symptoms. That trial, called RELIANCE -OLS or Study 310, had no placebo control, however.
Relmada is still moving forward with its modified, low-dose form of psilocybin, REL-P11, in metabolic diseases. Phase 1 dosing began in mid-November, with the company planning on launching a phase 2 study in the first half of 2025.