Rapport’s bipolar-mania study meets its primary endpoint in Phase 2

Rapport Therapeutics ($RAPP) reported positive topline results from a randomized, double-blind Phase 2 trial of RAP-219 in 253 adults with acute mania associated with bipolar I disorder. After three weeks, the treatment group improved by 15.4 points on the Young Mania Rating Scale, compared with 12.3 points on placebo. The 3.1-point difference met the primary endpoint, with a reported p-value of 0.045.

Adverse events occurred in 51.6% of treated participants and 52.8% of placebo recipients. Treatment discontinuations were 3.2% and 0.8%, respectively, with no serious or severe adverse events reported during the short study. Rapport plans two Phase 3 trials in the second half of 2027 following FDA discussions. The findings support further development, but a three-week Phase 2 result does not establish long-term effectiveness, long-term safety or regulatory approval.

Sources:

• Rapport — issuer clinical-results release