Recursion(US:RXRX)2025-12-08 14:02Recursion Pharmaceuticals (NasdaqGS:RXRX) Update Summary Company Overview - Company: Recursion Pharmaceuticals - Focus: Development of REC-4881 for Familial Adenomatous Polyposis (FAP) - Key Personnel: Najat Khan (Chief R&D and Commercial Officer, incoming CEO), Dr. Beth Bruckheimer (FAP clinical lead), Dr. David Mauro (Chief Medical Officer) Industry Context - Disease: Familial Adenomatous Polyposis (FAP) - Patient Population: Over 50,000 patients in the U.S. and EU5 affected by FAP - Current Treatment Landscape: No approved pharmacotherapies for FAP; patients undergo frequent surgeries and interventions Core Findings and Insights 1. Unmet Need: FAP is a progressive disease with no approved treatments, leading to severe interventions and surgeries, including the Whipple procedure [2][15][18] 2. Mechanism of Action: REC-4881 is a selective MEK1/2 inhibitor that targets the underlying biology of FAP by addressing the loss of APC gene function [3][20] 3. Clinical Study Results: - Phase 1b/2 TUPELO study shows that 75% of patients experienced a reduction in polyp burden by week 13, with a median reduction of 43% [25][31] - Durable effects observed, with 82% of patients maintaining a response at week 25, showing a median reduction of 53% [27][29][32] 4. Safety Profile: Consistent with MEK inhibitor class expectations; primarily grade 1-2 adverse events, with no grade 4-5 events reported [4][25][31] Additional Insights 1. Real-World Evidence: The ClinTECH platform analyzed over 1,000 FAP patients, revealing the relentless progression of polyp growth and the need for effective therapies [10][11][17] 2. Regulatory Engagement: Plans to engage with the FDA in the first half of 2026 to discuss a potential registrational pathway for REC-4881 [5][33] 3. Partnerships and Financials: Over $500 million generated from collaborations, indicating strong partnership momentum [7][8] Future Directions - Expansion of Patient Population: Broadening eligibility from patients over 55 to those over 18 years old [5][33] - Dosing Optimization: Exploring alternative dosing regimens to enhance the benefit-risk profile of REC-4881 [33] - Long-term Goals: Aim to provide a much-needed therapeutic option that can significantly improve the quality of life for FAP patients [15][33] Conclusion - REC-4881 represents a significant advancement in the treatment of FAP, with promising efficacy and safety data, addressing a critical unmet need in a patient population that currently lacks effective pharmacotherapy options [31][33]