Rapport's RAP-219 squeaks past placebo in Phase 2 bipolar mania trial
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Rapport Therapeutics reported that its lead drug RAP-219 met the primary endpoint in a Phase 2 trial enrolling 253 patients with acute bipolar mania. The drug produced a 3.1-point placebo-adjusted improvement on the Young Mania Rating Scale, statistically significant at p=0.045. That effect size sits at the low end of the 3-4 point range that existing approved drugs achieve in this indication, raising questions about how competitive the asset can be if it moves forward. The company describes the result as just meeting its target. Larger late-stage trials would be needed to confirm the finding and establish the drug's place among current treatments.
Written by a model from the reports · updated 1 hour ago
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- BioPharma DivePickRapport’s epilepsy drug finds surprising success in bipolar trial
Rapport's RAP-219 met the primary endpoint in a Phase 2 trial in bipolar mania, improving scores by 3.1 points more than placebo at week 3 with statistical significance. The study enrolled about 250 adults with bipolar mania; the RAP-219 group improved an average of 15.4 points at week 3 on the primary scale versus 12.3 points for placebo. All 11 scale components and a secondary mania severity endpoint beat placebo, and adverse events were mild to moderate with similar incidence between groups.
- BioSpaceRapport ekes out bipolar mania win as lead asset ‘just hits’ in mid-stage trial
Rapport Therapeutics announced that its lead drug RAP-219 met the primary endpoint in a Phase 2 trial of 253 patients with acute bipolar mania, with a placebo-adjusted improvement of 3.1 points on the Young Mania Rating Scale (p=0.045), at the low end of the 3-4 point range considered competitive with existing drugs.
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