Rapport Therapeutics Conference Call Summary Company Overview - Company: Rapport Therapeutics - Focus: Precision neuroscience, specifically through receptor-associated proteins - Lead Program: RAP-219, a TARP8 AMPA modulator targeting focal onset seizures and bipolar mania [4][5] Key Points and Arguments Product Development and Milestones - RAP-219: Demonstrated a best-in-class profile in focal onset seizures with a robust efficacy and tolerability profile [5][8] - Phase Two Results: Showed over 70% reduction in seizures over an eight-week period, with 24% of patients achieving complete seizure freedom [9][11] - FDA Meeting: Scheduled for Q4 2025 to discuss end of phase two results and path forward for pivotal studies in 2026 [18][19] - Bipolar Mania Study: Ongoing evaluation of RAP-219 with expected data in 2027 [5][6] Market Opportunity - Focal Onset Seizures: Approximately 1.8 million patients in the U.S. with 30-40% being treatment-resistant, representing a $10 billion-$15 billion market [11][12] - Polypharmacy Management: RAP-219 aims to provide a novel mechanism of action with better tolerability compared to existing treatments [12][13] - Long-Acting Injectable (LAI): Development underway, expected to be transformational for patients, with potential for once-monthly or quarterly dosing [15][33][34] Safety and Efficacy - Tolerability Profile: RAP-219 showed no severe adverse events, with most being mild or moderate, even among patients on multiple background anti-seizure medications [9][10] - Long Half-Life: RAP-219 has a half-life of over 18 days, which may help prevent breakthrough seizures if doses are missed [13][28] Future Data and Expectations - Upcoming Data Releases: Full trial results from phase two and open-label extension study expected in 2026 [6][27] - Phase Three Design: Standard design anticipated, focusing on seizure reduction and responder analysis [20][21] - Bipolar Program Read-Through: Positive implications for RAP-219's efficacy in treating acute mania due to its mechanism targeting glutamate pathways [37][38] Additional Important Insights - Market Research: Indicated that RAP-219 will be utilized by both epileptologists and general neurologists across various treatment lines [14] - Patient Population: Phase two study included heavily treated patients, suggesting robust efficacy in difficult-to-treat populations [24] - Regulatory Strategy: Ongoing discussions with the FDA to align on NDA submission requirements [19][36] This summary encapsulates the critical aspects of Rapport Therapeutics' conference call, highlighting the company's strategic direction, product development, market potential, and future expectations.
Rapport Therapeutics (NasdaqGM:RAPP) 2025 Conference Transcript