Research
Rapport’s RAP-219 meets main goal in Phase 2 bipolar mania study
Rapport said RAP-219 improved mania symptoms more than placebo over three weeks, with a statistically significant difference on the study’s main measure.
Rapport Therapeutics said its experimental oral drug RAP-219 met the main goal in a Phase 2 study of adults with bipolar mania. BioPharma Dive reported that the study enrolled around 250 adults, who received the drug or placebo once a day for three weeks.
On a 0 to 60-point scale, with higher scores indicating more severe symptoms, patients taking RAP-219 improved an average of 15.4 points by the third week, compared with 12.3 points for placebo, according to Rapport. The 3.1-point difference was statistically significant. Rapport also reported improvements across all 11 components of the scale and on a secondary measure. Adverse events were mild to moderate, and their incidence was similar in both groups.
The reports differ on the timing of the next-stage studies. Endpoints News said registrational studies are slated to start next year. BioPharma Dive reported that Rapport plans to discuss the results and trial design with the FDA in the first three months of next year, and said two late-stage trials should start in the back half of 2027.
