-+ 0.00%

Recursion Reports Phase 1b/2 TUPELO Results Showing REC-4881 Rapid And Durable Reductions In Polyp Burden In FAP, Supporting 1H26 FDA Engagement

Benzinga·12/08/2025 12:35:50

Listen to the news

REC-4881 (4 mg QD) achieved rapid clinical activity, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment (n=12)
After 12 weeks off therapy (week 25 of the study), 82% of evaluable patients (9 of 11) maintained a durable reduction in total polyp burden, with a 53% median reduction observed from baseline
Natural history analysis showed that 87% of untreated FAP patients - who resembled the inclusion criteria of TUPELO - had annualized polyp-burden increase, 10% remained stable, and 3% showed modest decrease—underscoring the disease's progressive trajectory (n=55)
40% of patients (4 out of 10) achieved a ≥1-point improvement in Spigelman stage—a clinically meaningful measure of upper GI disease severity to assess surveillance and clinical management
REC-4881 (4 mg QD) has a safety profile consistent with MEK1/2 inhibition, with the majority of treatment-related adverse events being Grade 1 or 2, Grade 3 events occurring in 15.8% of the safety-evaluable patients, and no Grade ≥4 TRAEs reported to date
First clinical validation of the Recursion OS, demonstrating how unbiased phenotypic and mechanistic insights—such as MEK1/2 rescue of APC loss-of-function—can translate to novel, differentiated therapeutics for diseases like FAP with no approved therapy and high prevalence of >50,000 patients in US and EU5
Next steps: Engage the FDA in the 1H26 to define a potential registration pathway, and in parallel, expand the population from ≥55 to ≥18 years old, and further optimize dosing schedule