Rapport Therapeutics Announces Positive Topline Results from its Phase 2 Trial of RAP-219 for the Treatment of Bipolar Mania
Rapport Therapeutics reported positive topline Phase 2 results for RAP-219 in acute bipolar mania, meeting the primary endpoint with a statistically significant 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045) and the CGI-BP secondary endpoint (0.4 points, p=0.024). RAP-219 was well tolerated, with TEAE rates similar to placebo (51.6% vs 52.8%), no severe TEAEs or SAEs, and an absence of somnolence, akathisia, and extrapyramidal symptoms common to existing mania therapies. The company plans an FDA End-of-Phase 2 meeting in Q1 2027 and initiation of two Phase 3 bipolar mania trials in 2H 2027, alongside ongoing Phase 3 epilepsy programs.
Key figures
- Drug Name
- RAP-219
- Phase Of Trial
- Phase 2
- Phase3 start
- second half of 2027
- Cash position
- $436.1 million as of June 30, 2026, funding operations into 2H 2029
- Primary endpoint
- YMRS total score placebo-adjusted LS mean improvement at Week 3: 3.1 points (p=0.045)
- Patients enrolled
- 253
- Secondary endpoint
- CGI-BP mania severity improvement: 0.4 points (p=0.024)
- Fda end of phase2 meeting
- Q1 2027
- Ymrs reduction from baseline
- 15.4 points (RAP-219) vs 12.3 points (placebo)
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