Relmada phase 3 RELIANCE I trial for REL-1017 fails primary endpoint; post-hoc analysis shows significance

RELMADA THERAPEUTICS, INC.

RELIANCE I did not achieve statistical significance on MADRS at Day 28: REL-1017 -15.1 vs placebo -12.9 (2.2-point difference).
Response rate statistically significant: 39.8% REL-1017 vs 27.2% placebo (p<0.05).
Post-hoc analysis excluding two high-enrolling centers with implausible placebo response showed 4.1-point MADRS difference (p=0.02).
Safety profile favorable: no opioid-like, withdrawal, or psychotomimetic effects; no QTcF prolongation.
Company is applying protocol and operational changes to the ongoing RELIANCE II trial.

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