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Rapport Therapeutics (NasdaqGM:RAPP) 2025 Conference Transcript
2025-11-17 14:02
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.