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Preliminary Phase 1b/2 Data for REC-4881 in Familial Adenomatous Polyposis (FAP) Demonstrates Reduced Polyp Burden
In the Phase 2 open-label study, REC-4881 (4 mg QD) led to a median 43% reduction (n=6 patients) in polyp burden at the Week 13 assessment at time of data
About this update from Recursion Pharmaceuticals, Inc.
[{"type":"text","content":"In the Phase 2 open-label study, REC-4881 (4 mg QD) led to a median 43% reduction (n=6 patients) in polyp burden at the Week 13 assessment at time of data cutoff.Five of six patients (83%) experienced reductions in polyp burden ranging from 31% to 82%, however, one patient showed a substantial increase from baseline.At Week 13, 50% of patients (3 out of 6) achieved ≥1-point improvement in Spigelman stage, a measure of upper GI disease severity.The early safety profile of REC-4881 was generally consistent with that of prior MEK1/2 inhibitors; among 19 patients across Phase 1b and 2, most treatment-related adverse events were Grade 1 or 2, with Grade 3 events in 16% of patients and no Grade ≥4 TRAEs reported to date. SALT LAKE CITY, May 04, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a clinical-stage TechBio company decoding biology to radically improve lives, today announced preliminary safety and efficacy results from its ongoing Phase 1b/2 TUPELO trial of REC-4881, an investigational, allosteric MEK1/2 inhibitor in development for Familial Adenomatous Polyposis (FAP). These data were presented in a late-breaking oral presentation at Digestive Disease Week (DDW) 2025 in San Diego, California. FAP is a rare, inherited disorder caused by mutations in the APC gene, leading to the growth of hundreds to thousands of gastrointestinal polyps and a near 100% lifetime risk of colorectal cancer if left untreated. Despite this significant burden, there are currently no FDA-approved treatments. FAP affects an estimated 50,000 individuals across the US and EU5 (France, Germany, Italy, Spain, and the UK). REC-4881 has received Fast Track and Orphan Drug designations from the U.S. FDA, as well as Orphan Drug designation from the European Commission. As of the March 17, 2025 data cutoff in the open-label Phase 2 portion of the TUPELO trial, treatment with REC-4881 (4 mg QD) led to a preliminary median 43% reduction to date in polyp burden at the Week 13 assessment among six efficacy-evaluable patients. Other investigational agents in separate studies have reported 20-30% polyp burden reduction in 6 months1. Five of the six patients (83%) experienced reductions in polyp burden ranging from 31% to 82%, while one patient (17%) showed a substantial increase of 595% from baseline. Additionally, three of six patients (50%) achieved a ≥1-point ...