Core Insights - Rapport Therapeutics (RAPP) shares increased by 61.6% within a week following the announcement of positive top-line data from a mid-stage study of its lead candidate, RAP-219, for drug-resistant focal onset seizures (FOS) [1][6] Study Details - The phase IIa RAP-219-FOS-201 study evaluated the efficacy, safety, and tolerability of RAP-219 in adults with drug-resistant FOS, enrolling thirty patients who received escalating doses over an eight-week treatment period [2][3] - The study met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) associated with seizure activity compared to baseline [3] Efficacy Results - During the eight-week treatment, 85.2% of patients experienced a ≥30% reduction in LEs, 72% achieved a ≥50% reduction in clinical seizures, and 24% attained seizure freedom [4] - RAP-219 was well-tolerated, with most adverse events being mild to moderate in severity, supporting its potential as a new anti-seizure medication [4] Future Plans - The company plans to engage with the FDA in late 2025 to discuss the phase IIa study results and aims to initiate pivotal studies for RAP-219 in Q3 2026 [8] - A long-term safety study of RAP-219 is set to launch by the end of 2025, allowing patients from the initial study to continue treatment, with preliminary data expected in H2 2026 [9] Broader Development - Rapport Therapeutics is expanding RAP-219's clinical program to include additional indications, with a phase II study for bipolar mania currently underway and results anticipated in H1 2027 [10]
RAPP Stock Soars 62% in a Week on Meeting Phase II Epilepsy Study Goal