From GlobeNewswire: 2025-05-04 12:45:00

Recursion announced preliminary results from a Phase 1b/2 TUPELO trial of REC-4881, an MEK1/2 inhibitor for Familial Adenomatous Polyposis (FAP). REC-4881 showed a median 43% reduction in polyp burden at Week 13, with 83% of patients experiencing reductions. Three out of six patients achieved a ≥1-point improvement in Spigelman stage. The safety profile was consistent with prior MEK1/2 inhibitors, with Grade 3 events in 16% of patients and no Grade ≥4 TRAEs. The trial is ongoing, with additional efficacy and safety analyses expected in the second half of 2025.

FAP is a rare disorder with no FDA-approved treatment, affecting 50,000 individuals in the US and EU5. REC-4881 has Fast Track and Orphan Drug designations. The Phase 2 study showed promising results with REC-4881 reducing polyp burden by a median of >43% in just three months of treatment, offering hope for FAP patients. REC-4881 is an MEK 1/2 inhibitor identified through Recursion’s AI-powered platform.

In the ongoing Phase 2 portion of the TUPELO trial, REC-4881 demonstrated a median 43% reduction in polyp burden at Week 13 among efficacy-evaluable patients. 50% of patients achieved a >50% reduction in polyp burden at Week 13, with some maintaining the reduction at Week 25. There were also improvements in Spigelman stage for some patients.

Safety data from the trial showed Grade 3 TRAEs in 16% of patients, with no Grade ≥4 events reported. Most TRAEs were Grade 1 or 2, with rash and diarrhea being common. The Phase 1b study included five patients on REC-4881, and the Phase 2 study enrolled patients aged ≥55 years.

Future steps for the TUPELO trial include ongoing patient enrollment, with additional analyses planned for the second half of 2025. REC-4881 is an MEK 1/2 inhibitor identified through Recursion’s platform, offering a potential treatment option for FAP patients.



Read more at GlobeNewswire: Preliminary Phase 1b/2 Data for REC-4881 in Familial