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- Relmada Therapeutics Inc's (NASDAQ:RLMD) RELIANCE III study (REL-1017-303) of REL-1017 in the monotherapy setting for Major Depressive Disorder (MDD) did not achieve its primary endpoint.
- The product candidate failed to achieve a statistically significant improvement in depression symptoms compared to the placebo.
- The REL-1017 treatment arm showed a symptom score reduction of 14.8 points at Day 28 versus 13.9 points for the placebo arm, a higher-than-expected placebo response.
- In August, the FDA granted Fast Track designation to REL-1017 for major depressive disorder.
- Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017. Relmada is investigating the nature of these results.
- REL-1017, administered for 28 days to 232 subjects in RELIANCE 3, demonstrated favorable tolerability and safety, confirming the results of Phase 1 and Phase 2 studies, with no opioid-like effects, withdrawal effects, and psychotomimetic effects.
- There were no adverse events related to QTcF prolongation.
- Relmada continues to enroll patients in RELIANCE I and RELIANCE II, two ongoing Phase 3 studies evaluating REL-1017 as a potential adjunctive treatment for MDD.
- Price Action: RLMD shares are down 78.1% at $6.94 during the premarket session on the last check Thursday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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