- Preliminary Phase 1b/2 data shows a >30% median reduction in polyp burden for FAP patients treated with REC-4881 after 12 weeks.
- 84.6% of patients experienced at least one mild to moderate treatment-related adverse event.
- REC-4881 has gained Fast Track and Orphan Drug designations from the FDA and European Commission.
Recursion (RXRX, Financial), a clinical-stage TechBio company, is set to present the preliminary clinical data from its Phase 1b/2 TUPELO trial of REC-4881 at the Digestive Disease Week on May 4, 2025, in San Diego. The trial focuses on the potential treatment of familial adenomatous polyposis (FAP), a rare genetic disorder affecting approximately 50,000 people across the United States and Europe, with no current FDA-approved therapies.
Key preliminary findings as of February 7, 2025, indicate that of the 13 patients receiving 4 mg of REC-4881 daily, 84.6% experienced at least one treatment-related adverse event. The most common side effect was a mild to moderate rash or dermatitis acneiform (Grade 1 or 2). Notably, in 5 efficacy-evaluable patients, there was a greater than 30% median reduction in total polyp burden after 12 weeks.
REC-4881, discovered through Recursion's AI-powered platform, acts as a non-ATP-competitive allosteric MEK 1/2 inhibitor targeting the cellular effects of APC gene loss, which is the root cause of FAP. The significance of REC-4881's regulatory approvals is underscored by its Fast Track and Orphan Drug designations by the FDA and the European Commission, reflecting the pressing medical need in FAP therapy.
The upcoming presentation at DDW will offer updated data from a more recent cutoff, potentially providing deeper insights into the treatment's efficacy and safety. Recursion's AI-driven discovery method not only offers hope for FAP patients but also stands as a proof-of-concept for developing novel therapeutic solutions through advanced technologies.
