Benzinga -
- Relmada Therapeutics Inc (NASDAQ: RLMD) announced the results of the RELIANCE I REL-1017-301 study evaluating REL-1017 as an adjunctive treatment for Major Depressive Disorder (MDD).
- The company says that the same factors that negatively affected the RELIANCE III study results resulted in this study not meeting its primary endpoint of statistically significant improvement in depression symptoms compared to the placebo.
- A limited number of high enrolling sites with unplausible placebo responses impacted the RELIANCE III study.
- In the study, the REL-1017 treatment arm showed a MADRS reduction of 15.1 points versus 12.9 points for the placebo arm and a statistically significant difference in the response rate (39.8% vs. 27.2%).
- In a post-hoc analysis of RELIANCE 1 (301 Study) that excluded the same two high enrolling centers that showed implausible placebo response in both REL-1017 studies, the REL-1017 treatment arm showed a MADRS reduction of 16.7 points versus 12.6 points for the placebo arm, a 4.1 point difference.
- Relmada continues to enroll patients in RELIANCE II, the second ongoing Phase 3 study evaluating REL-1017 as a potential adjunctive treatment for MDD.
- Based on the results of RELIANCE I and RELIANCE III, Relmada is applying several protocols and operational changes to RELIANCE II.
- Price Action: RLMD shares closed 39.40% lower at $2.52 during the premarket session on the last check Thursday.