Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target

Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at week 3.

The trial recorded a 3.1-point placebo-adjusted gain, which is below the 4-point improvement the company had described as the clinically meaningful threshold and lower than the 4-to-7-point gains seen with existing therapies.

Despite the modest effect size, CEO Abe Ceesay called the data positive and said the company will move forward with phase 3 trials planned for next year, while analysts note the result leaves uncertainty about the drug's commercial potential.