Relmada Therapeutics, Inc. announced that its 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 Scaleon Day 28. In the 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.

Relmada is investigating the nature of these results. 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.