India Pharma Outlook Team | Wednesday, 10 December 2025
In a promising leap for rare disease care, Recursion Pharmaceuticals revealed that its investigational drug REC-4881 delivered strong polyp reduction in patients with Familial Adenomatous Polyposis (FAP), a rare hereditary condition that drastically increases colorectal cancer risk.
The December 8, 2025 update says 9 of 11 patients maintained a durable polyp burden reduction, with a median 53 % drop 12 weeks after therapy ended.
On the study’s earlier assessment, after 12 weeks of daily 4 mg dosing, 75 % of treated patients saw polyp reductions, with a median 43 % fall in total polyp burden. For many, the benefits lasted — underscoring REC-4881’s potential as a non-surgical alternative for FAP management.
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“This is the first clinical validation of Recursion’s AI platform, where we garnered unbiased insights to know that this molecule could work in this disease and now proving it in patients with this latest data,” said incoming CEO Najat Khan.
From a safety standpoint, the drug’s side-effect profile remained consistent with expectations for MEK1/2 inhibitors: most treatment-related adverse events were mild to moderate (Grade 1 or 2), with a minority experiencing Grade 3 events and no Grade 4 or higher reported.
From an industry lens, REC-4881’s results mark a milestone: it is among the first small-molecule therapies discovered through an AI-driven platform to show real, durable clinical benefit in a rare, high-risk disease with no approved medical therapies. As the company moves toward regulatory engagement in early 2026, REC-4881 could transform how FAP is treated — potentially sparing patients from costly, life-altering surgeries.
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