Rapport Therapeutics Announces Positive Topline Results from its Phase 2 Trial of RAP-219 for the Treatment of Bipolar Mania
Key Highlights
- ➤RAP-219 cut YMRS scores 3.1 points versus placebo at Week 3 (p=0.045)
- ➤RAP-219 achieved 15.4-point mean YMRS reduction from baseline at Week 3
- ➤CGI-BP mania severity improved 0.4 points versus placebo at Week 3 (p=0.024)
- ➤Rapport expects two bipolar mania Phase 3 trials to begin in the second half of 2027
- ➤Rapport held $436.1 million in cash and investments as of June 30, 2026
Expert Statements
Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics
“For people with bipolar disorder, the challenge isn’t just finding a treatment that’s efficacious. It’s finding one they can tolerate and stay on”
Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics
“Side effects drive discontinuation, and discontinuation drives relapse. RAP-219 has the potential to break that cycle with the first new mechanism of action for bipolar mania in decades.”
Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics
“Together with our positive Phase 2 focal epilepsy data, these results strengthen RAP-219’s profile across each indication we are pursuing and show it delivering on its potential as a pipeline-in-a-product with two indications that both represent multibillion dollar market opportunities.”
Abraham N. Ceesay, Chief Executive Officer of Rapport Therapeutics
“We look forward to engaging with the FDA on Phase 3 in bipolar mania, alongside our ongoing Phase 3 epilepsy programs.”
Jeffrey Sevigny, M.D., Chief Medical Officer of Rapport Therapeutics
“In this proof-of-concept study, RAP-219 demonstrated statistically significant improvement across measures of mania symptoms as well as a favorable tolerability profile.”
Jeffrey Sevigny, M.D., Chief Medical Officer of Rapport Therapeutics
“This is important because tolerability issues lead many patients to discontinue their therapies.”
Jeffrey Sevigny, M.D., Chief Medical Officer of Rapport Therapeutics
“These results continue to build our confidence in the safety profile of RAP-219, and the insights learned from this study will guide us in optimizing the Phase 3 design in bipolar mania.”
Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital and Associate Clinical Professor of Psychiatry at Harvard Medical School
“There hasn’t been a new mechanism to treat bipolar mania in decades.”
Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital and Associate Clinical Professor of Psychiatry at Harvard Medical School
“In this study, RAP-219 achieved statistically significant improvement in manic symptoms with an encouraging tolerability profile, underscoring the promise of this novel mechanism.”
Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital and Associate Clinical Professor of Psychiatry at Harvard Medical School
“Importantly, clinical benefit was seen consistently across all measures, with the greatest improvements in symptoms that tend to drive hospitalization for acute mania patients.”
Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital and Associate Clinical Professor of Psychiatry at Harvard Medical School
“What is encouraging about the tolerability profile is what was not seen on RAP-219--the somnolence, akathisia, and extrapyramidal symptoms that often cause patients to discontinue treatment.”
Gary Sachs, M.D., Founding Director of the Bipolar Clinic and Research Program at Massachusetts General Hospital and Associate Clinical Professor of Psychiatry at Harvard Medical School
“Based on these results, RAP-219 has the potential to become a mainstay of treatment for acute mania.”
The trial met the primary and secondary endpoints with statistically significant placebo-adjusted improvements at Week 3 in the YMRS total score (3.1 points; p=0.045) and CGI-BP Severity of Mania score (0.4 points; p=0.024)
RAP-219–treated patients had a 15.4-point mean reduction in YMRS total score from baseline at Week 3
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