RLMD - Relmada stock crashes 78% as depression therapy REL-1017 fails phase 3 trial

Relmada Therapeutics ( NASDAQ: RLMD ) said its drug REL-1017 did not meet the main goal of showing statistically significant improvement in depression symptoms compared to placebo in a phase 3 trial to treat patients with major depressive disorder.

In the late stage study, dubbed RELIANCE III  (REL-1017-303), REL-1017 as a standalone therapy, was administered for 28 days to 232 people.

The REL-1017 treatment group showed a reduction of 14.8 points on the diagnostic questionnaire called MADRS (Montgomery-Asberg Depression Rating Scale) at Day 28, compared to 13.9 points for the placebo arm, a higher than expected placebo response, the company said in an Oct. 13 press release.

Relmada added that paradoxical results were seen in certain study sites, where placebo dramatically outperformed REL-1017.

The company noted that it also conducted another analysis in which sites with implausibly high or low placebo responses were excluded. This showed a meaningful difference between REL-1017 and placebo.

REL-1017 showed a favorable tolerability and safety profile in the study.

Relmada said RELIANCE I and II trials of REL-1017 as adjunctive treatment of MDD continue to advance.

RLMD -77.91% to $7.00 premarket Oct. 13

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