Rapport Therapeutics Conference Call Summary Company Overview - Company: Rapport Therapeutics (NasdaqGM:RAPP) - Focus: Development of RAP-219 for focal onset seizures and other indications Key Industry Insights - Market Need: Despite over 30 approved anti-seizure medications, up to 40% of patients continue to experience seizures, indicating a significant unmet need in the focal epilepsy market [5][6] - Potential Market Size: RAP-219 is believed to represent a multi-billion dollar commercial opportunity, subject to approval [6][19] Core Findings from the Phase 2A Trial of RAP-219 - Efficacy Results: - 78% reduction in clinical seizure frequency [4][14] - 24% seizure freedom rate [4][23] - 71% median reduction in long episode frequency from baseline [12] - 85.2% of patients achieved a 30% or greater reduction in long episodes [13] - 72% of patients achieved a 50% or greater reduction in clinical seizures [15] - Safety Profile: RAP-219 was generally well tolerated, with common treatment-emergent adverse events (TEAEs) being dizziness, headache, and fatigue [16] - Dosing Convenience: Once-daily dosing and low risk of drug-drug interactions enhance the potential for widespread adoption among healthcare providers [6][18] Development Plans and Future Steps - Next Steps: Plans to meet with the FDA for an end-of-Phase 2 meeting in Q4 2025 and initiate Phase 3 trials in Q3 2026 [17][19] - Long-Acting Injectable (LAI): Development of an LAI formulation is ongoing, which could improve patient adherence and expand clinical utility [18] - Bipolar Mania Trials: Ongoing Phase 2 trial in bipolar mania, with expectations for data in early 2027 [52] Additional Insights - Physician Feedback: Positive reception from physicians regarding RAP-219's profile, with expectations for it to be used in both refractory settings and earlier in treatment algorithms [64][66] - Translatability to Phase 3: Confidence in the translatability of Phase 2 results to Phase 3 trials, with a baseline seizure frequency of 10 being representative of typical disease burden [22][24] - Market Dynamics: The competitive context and the drug's profile are expected to facilitate efficient patient recruitment for Phase 3 trials [41][42] Conclusion - RAP-219 demonstrates promising efficacy and safety profiles, positioning it as a potential best-in-class treatment for focal onset seizures and possibly other indications. The company is well-prepared to advance its development plans and capitalize on the significant market opportunity.
Rapport Therapeutics (NasdaqGM:RAPP) Update / Briefing Transcript