Efficacy and Safety of REC-4881 in Participants With Familial Adenomatous Polyposis (FAP)

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate efficacy, safety, and pharmacokinetics of REC-4881 in participants with Familial Adenomatous Polyposis (FAP).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Recursion Pharmaceuticals Inc.

Criteria

Inclusion Criteria:

1. ≥ 18 years of age

2. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or residual colon/rectum/pouch

3. Genetic diagnosis of FAP with APC gene mutation (Part 2 only)

4. Has undergone colectomy or subtotal colectomy; individual may not have an intact colon

Exclusion Criteria:

1. Prior pelvic irradiation

2. Gastrointestinal disease or recent gastrointestinal procedure that could interfere with oral absorption of REC-4881, including difficulty swallowing capsules

3. Received treatment with other investigational agents within the 4 weeks prior to initial dosing with study drug

4. Treatment with other FAP-directed drug therapy (including celecoxib, sulindac or fish oil) within 8 weeks of study screening

5. Regularly using aspirin in excess of 700 mg per week or NSAIDs at any dose.

6. Use of omega-3 fatty acids or oral corticosteroids within 30 days of initial dosing with study drug.

7. Currently taking any strong CYP3A inhibitors or inducers [Participants may discontinue use of these agents at least 14 days prior to screening and be eligible]

8. History of an ongoing or newly diagnosed eye abnormality

9. Cancer on biopsy at screening in GI tract (including stomach, duodenum, and colon/rectum/pouch)

10. Received treatment with another MEK inhibitor within 2 months of Screening.