Rapport Therapeutics says Phase 2 RAP-219 trial in bipolar mania met primary, secondary endpoints (28.60)
- RAP-219 showed a statistically significant 3.1-point placebo-adjusted improvement in YMRS total score at Week 3 (p=0.045) in adults with acute bipolar mania.
- The pre-specified secondary endpoint was also met, with a 0.4-point improvement in CGI-BP mania severity score versus placebo (p=0.024).
- Rapport said RAP-219 was well tolerated, with no severe treatment-emergent adverse events or serious adverse events during the three-week treatment period.
- The company said the data support moving into Phase 3 trials in bipolar mania, which are expected to begin in 2H27, alongside ongoing Phase 3 epilepsy programs.