Relmada : Phase 3 Study Of REL-1017 In Major Depressive Disorder Fails To Meet Main Goal; Stock Down

(RTTNews) - Relmada Therapeutics Inc. (RLMD) said Thursday that its Phase 3 RELIANCE III study, evaluating REL-1017 in the monotherapy setting for Major Depressive Disorder, did not achieve its primary endpoint, which was a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale or MADRS on Day 28.

In Thursday pre-market trade, RLMD was trading at $6.39 down $25.30 or 79.84%.

In the Phase 3 RELIANCE III study, the REL-1017 treatment arm showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher than expected placebo response. Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017.

REL-1017, which was administered for 28 days to 232 subjects in RELIANCE III, demonstrated very favorable tolerability and safety, confirming the results of Phase 1 and Phase 2 studies, with no opioid-like effects, no withdrawal effects, and no psychotomimetic effects. There were no adverse events related to QTcF prolongation.

Relmada noted that it continues to enroll patients in RELIANCE I and RELIANCE II, two ongoing Phase 3, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment for Major Depressive Disorder.