Rapport Therapeutics announced positive topline results from its Phase 2a clinical trial of RAP-219 in patients with drug-resistant focal onset seizures. The trial met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs), an objective electrographic biomarker for clinical seizure reduction, compared with baseline over the 8-week treatment period.
Key efficacy findings showed that 85.2% of patients achieved a 30% or greater reduction in LEs from baseline (p<0.0001). Furthermore, RAP-219 demonstrated a statistically significant and clinically meaningful reduction in clinical seizures, with 72.0% of patients achieving a 50% or greater reduction from baseline (p<0.0001), and 24% of patients achieving seizure freedom (p<0.0001).
RAP-219 was generally well tolerated in the trial, with the majority of treatment-emergent adverse events being mild and a low discontinuation rate. Based on these strong results, Rapport plans to advance RAP-219 into two Phase 3 pivotal trials in the third quarter of 2026, following an end-of-Phase 2 meeting with the FDA in the fourth quarter of 2025.
The company also plans to initiate an open-label long-term safety trial by the end of 2025 and continues development of a long-acting injectable formulation of RAP-219. These developments underscore the potential for RAP-219 to address a significant unmet need in drug-resistant focal onset seizures and support broad adoption among neurologists.
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