Key points:
- Relmada Therapeutics depression drug fails to meet late-staget study goal
- The drug did not show a statistical improvement
- Relmada shares plunged over 80%
Relmada Therapeutics (NASDAQ: RLMD) announced on Thursday that its therapy to treat major depressive disorder did not achieve its primary endpoint.
The biotechnology firm announced that its RELIANCE III study, which evaluates REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD), did not show a statistically significant improvement in depression symptoms compared with its placebo.
Shares of Relmamada plummeted 83% premarket to $5.31 per share at the time of writing following the announcement.
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The treatment arm showed a MADRS reduction of 14.8 points on Day 28 versus 13.9 points for the placebo arm, a higher-than-expected placebo response.
The company said the outcomes were observed in certain study sites, where the placebo significantly outperformed REL-1017. Therefore, Relmada is looking into the nature of these results.
REL-1017 showed extremely favorable tolerance and safety when administered to 232 subjects for 28 days in RELIANCE III. In addition, subjects reportedly faced no opioid-like effects, withdrawal effects and no psychotomimetic effects.
“While these RELIANCE III results are disappointing for patients, the need for new, safe and effective treatments for MDD continues to exist,” said Maurizio Fava, Psychiatrist-In-Chief, Massachusetts General Hospital, and Slater Family Professor of Psychiatry, Harvard Medical School.
The company stated that it continues to enroll patients in RELIANCE I and RELIANCE II, two ongoing Phase 3 studies, evaluating REL-1017 as a potential adjunctive treatment for MDD.