Evaluate REC-4881 in Patients With FAP

Inclusion Criteria:

1. Male or female and ≥ 55 years of age

2. Have provided written informed consent to participate in the study

3. Diagnosis of phenotypic classical FAP with disease involvement of the duodenum orthe residual colon/rectum/pouch as the primary disease site.

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

5. Has undergone colectomy or subtotal colectomy

6. Spigelman Classification Stage II or higher.

7. Investigator/Participant agrees to leave polyps ≤10 mm unresected during endoscopiesperformed at Screening and while on study

8. Have no significant cardiovascular abnormalities at Screening:

9. Left ventricular ejection fraction >50% as determined on screeningechocardiogram

10. A QT interval corrected for heart rate using the Fridericia formula (QTcF) < 450 msec in men and <470 msec in women.

11. Have no significant hematopoietic abnormalities at Screening:

12. White blood cell count (WBC) ≥ 3,000/mm3 (non-black populations); 2,700/mm3 (black populations)

13. Platelet count ≥ 120,000/mm3

14. Hemoglobin ≥ 10.0 g/dL

15. No history of clinical coagulopathy.

16. Have no significant hepatic abnormalities at Screening:

17. Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (individuals with Gilbertsyndrome may be enrolled)

18. AST, ALT, ALP ≤ 2.0 X ULN.

19. Have no significant renal abnormalities at Screening: serum creatinine ≤ 1.5 times XULN.

20. Female participants who are women of childbearing potential (WOCBP) must have anegative serum pregnancy test at screening and a negative urine pregnancy testwithin 24 hours before the first dose of study drug. If the urine test is positiveor cannot be confirmed negative, a serum pregnancy test will be required and must benegative for the participant to be eligible.

21. All participants must be willing to follow the contraceptive guidance in theprotocol and must not be lactating or planning to attempt to become pregnant duringthe study or for a further period of 4 months after the last dose of study drug orimpregnate someone during this study or for a further period of 14 weeks after thelast dose of study drug (Appendix 1).

22. Absence of gross blood in stool at Screening; red blood on toilet paper only isacceptable.

23. Participant must be willing to discontinue use of non-steroidal anti-inflammatoryagents (NSAIDs) 6 weeks prior to Study Day 1 and remain off NSAIDs throughout thetreatment period of the study (use of aspirin ≤ 700 mg week is allowed.)

Exclusion Criteria:

1. Has any clinically significant laboratory abnormality, medical or psychiatricillness which, in the opinion of the Investigator, could interfere with the conductor interpretation of the study or put the participant at risk.

2. Has had prior pelvic irradiation.

3. Has gastrointestinal disease or recent gastrointestinal procedure that couldinterfere with oral absorption of REC-4881, including difficulty swallowingcapsules.

4. Has received treatment with other investigational agents within the 4 weeks prior toStudy Day 1 or a period during which the investigational agent has not been clearedfrom the body (i.e., at least a period of 5 half-lives, if known), whichever islonger.

5. Treatment with other FAP-directed drug therapy within 8 weeks of screening endoscopy (Part 2 only) or had a Whipple procedure.

6. Is currently under treatment for desmoid tumors.

7. Use of omega-3 fatty acids or oral corticosteroids prior to Study Day 1

8. Use of strong CYP3A inhibitors or inducers prior to Study Day 1

9. History of an ongoing or newly diagnosed eye abnormality.

10. Retinal pathologies such as diabetic retinopathy, veno-occlusion, or macularedema

11. Corneal pathologies such as herpes keratitis, corneal dystrophy, cornealerosions, corneal degeneration, active or recurrent keratitis, or uveitis (intermittent, posterior, and/or panuveitis)

12. Other clinically significant ophthalmologic abnormalities (e.g., retinaldetachment) or has findings at Screening. [Participants with corrected myopiamay be enrolled.]

13. Has cancer at screening endoscopy in GI tract (including stomach, duodenum, andcolon/rectum/pouch) (Part 2 only).

14. Has a large polyp (>1 cm) not amenable to complete removal

15. Has active pancreatitis secondary to pancreatic duct obstruction

16. Has active gall bladder disease

17. Is pregnant, lactating or is planning to attempt to become pregnant during thisstudy or within 4 months after the last dose of study drug (women) or is planning toattempt to impregnate someone or donate sperm during the study or within 14 weeksafter the last dose of study drug (men).

18. Has had major surgery prior to Study Day 1

19. Has an active infection requiring systemic therapy.

20. Has known hypersensitivity to the study drug or its excipients.

21. Has a history of alcohol or substance abuse within 1 year prior to screening forstudy participation, or is currently using alcohol, drugs of abuse, or anyprescribed or over-the-counter medication in a manner which, in the opinion of theInvestigator, indicates abuse .

22. Received treatment with another MEK inhibitor 8 weeks prior to Screening andthroughout the treatment period of the study.

23. Any of the following known active infections:

24. HIV not optimally controlled or treated. Participants with HIV who are onsustained stable antiretrovirals (for >4 weeks) and have CD4+ counts ≥ 350cells/μL may be enrolled. No HIV testing is required unless clinicallyindicated or mandated by local health authority.

25. Chronic hepatitis B virus (HBV) infection with surface antigen positive:participants with a prior history of treated HBV infection who are hepatitis Bsurface antigen-negative may be enrolled. No testing is required for hepatitisB unless clinically indicated or mandated by local health authority

26. Chronic hepatitis C virus (HCV) infection: untreated or on active treatment.Participants with a prior history of treated HCV infection who are HCVRNA-undetectable may be enrolled. No testing is required for hepatitis C unlessclinically indicated or mandated by local health authority.

27. Has a severe or uncontrolled medical condition (e.g., dermatologic disease, etc.)that, in the opinion of the Investigator, would pose a significant clinical risk forthe participant.

28. Use of strong BCRP or MRP2 inhibitors within 14 days of Study Day 1 and throughoutthe treatment period of the study.

29. Clinically significant cardiovascular disease ≤ 6 months before first dose

30. Myocardial infarction or unstable angina

31. Clinically significant cardiac arrhythmias

32. Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mmHg, diastolicblood pressure (DBP) > 100 mmHg

33. Pulmonary embolism, symptomatic cerebrovascular events or any other seriouscardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy)

34. QTcF prolongation >450 msec in males and >470 msec in females at screening orhistory of long QTc syndrome

35. Congestive heart failure (New York Heart Association class III-IV)

36. Myocarditis / clinically significant pericarditis.