Relmada decimated as MDD candidate fails in Phase III trial

Late-stage US biotech Relmada Therapeutics’ (Nasdaq: RLMD) shares sank 78% to $7.00 by mid-morning, after it revealed that its RELIANCE III study (REL-1017-303), evaluating REL-1017 in the monotherapy setting for major depressive disorder (MDD), 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 (MADRS) on Day 28.

Relmada noted that, 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.

MDD is a challenging space for development (~50% of late-stage MDD trials fail), so this should not be unexpected, commented SVB Securities analyst Marc Goodman. And the RELIANCE I and II readouts probably have a better chance to work versus RELIANCE III given the placebo impact should be relatively more manageable, and that the previously reported positive Phase II POC study was also in the adjunctive setting, he noted.