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The P-II trial in adults, met its 1EP, where RAP-219 achieved a 3.1-point LS mean improvement over PBO in the YMRS total score at Wk. 3, with a 15.4-point LS mean reduction from baseline of 36.9, supporting 2 P-III trials (expected to begin in H2’27)
All 11 YMRS items improved, with 4 reaching nominal significance. PBO-adjusted improvements progressed from 0.9 at Wk. 1 to 2.2 at Wk. 2 & 3.1 at Wk. 3. The 2EP also showed significant improvement in CGI-BP mania severity
Rapport plans an FDA meeting in Q1’27 to discuss RAP-219’s P-II data & P-III design. P-III (FOCUS 1 & 2) trials in focal onset seizures (FOS) are enrolling, OLE P-IIa data in FOS are expected in Q4’26, P-III trials for PGTCS are planned for H1’27, & LAI formulation P-I PK data are expected in Q3’27
Ref: Rapport | Image: Rapport | Press Release
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Rapport Therapeutics Reports Topline P-II Trial Results on RAP-219 in Bipolar Mania | PharmaVoice