Clinical TrialOct 20, 2026, 06:07 AM
Rapport Therapeutics: RAP-219 Phase 2 Bipolar Mania Trial Meets Primary Endpoint
AI Summary
Rapport Therapeutics announced positive topline results from its Phase 2 trial of RAP-219 for the treatment of bipolar mania. The trial met its primary endpoint, demonstrating a statistically significant 3.1-point placebo-adjusted improvement in the Young Mania Rating Scale (YMRS) total score at Week 3. RAP-219 was also well-tolerated, with a similar incidence of treatment-emergent adverse events (TEAEs) compared to placebo and no serious adverse events (SAEs) reported. The company plans to advance RAP-219 to Phase 3 trials, expected to commence in the second half of 2027, and has sufficient cash reserves to fund operations into the second half of 2029.
Key Highlights
- Rapport Therapeutics announces positive topline results from Phase 2 trial of RAP-219 for bipolar mania.
- Trial met primary endpoint: RAP-219 showed a 3.1-point placebo-adjusted improvement in YMRS total score at Week 3 (p=0.045).
- RAP-219 demonstrated a statistically significant improvement in mania severity (CGI-BP-S) vs placebo (p=0.024).
- RAP-219 was well-tolerated with mild or moderate treatment-emergent adverse events (TEAEs); incidence similar to placebo.
- No serious adverse events (SAEs) observed; low discontinuation rate due to TEAEs (3.2% vs 0.8% for placebo).
- Phase 3 trials for RAP-219 in bipolar mania are expected to begin in the second half of 2027.
- Company has $436.1 million in cash, expected to fund operations into the second half of 2029.
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