Rapport Therapeutics has announced that its oral treatment for acute bipolar mania, RAP-219, met its primary and secondary endpoints in a phase 2 trial, demonstrating a statistically-significant improvement compared to a placebo.
At week 3, patients in the treatment group had a mean reduction in Young Mania Rating Scale (YMRS) total score from baseline of 15.4 points, compared to 12.3 points with the placebo, with a numerical improvement to all 11 items measured. The drug was well tolerated with only mild or moderate treatment-emergent adverse events recorded during the treatment period.
The trial has established clinical proof-of-concept for RAP-219 and its novel mechanism in bipolar mania, which support progression to phase 3 trials in the second half of 2027. The TARPγ8-specific AMPAR negative allosteric modulator had already achieved clinical proof-of-concept to treat drug-resistant focal onset seizures, and it is currently being evaluated in phase 3 clinical trials for this indication.
If eventually approved, RAP-219 would be the first new mechanism to treat bipolar mania in decades.