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NCT05552755 (REC-4881 in Familial Adenomatous Polyposis): BVCT ex-ante prediction vs. reported outcome

On 3 Nov 2024, BioinvestGPT's BVCT predicted technical partial success and commercial success for this trial. The 4 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically probably significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT05552755
Acronym
TUPELO
Drug Name
REC-4881
Drug MoA
oral non-ATP-competitive MEK1/MEK2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Familial Adenomatous Polyposis (FAP)
Human Patients
67
Sponsor
Recursion Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1818

Prospective Prediction
Prediction Index
1818
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in polyp burden at week 24 superior to celecoxib)
Technical Prediction
partial SUCCESS (statistically maybe significant yet moderate clinical benefit in polyp burden at week 12 against placebo with a positive duration-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
182 days in advance
Readout Data Interpretation
REC4881 achieved a median 43% reduction in polyp burden at week 13; superior to celecoxib’s 28% reduction in polyp burden at week 24 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 1b-2, Multicenter, Trial to Evaluate the Efficacy, Safety, Pharmacokintetics, and Pharmacodynamics of REC-4881 in Patients With Familial Adenomatous Polyposis (FAP)
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
67
Lead sponsor
Recursion Pharmaceuticals Inc.
Conditions
Familial Adenomatous Polyposis
Interventions
DRUG: REC-4881; DRUG: Placebo
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-07-10
Primary completion
2027-06
Completion
2027-09
Primary outcomes
  • Part 1: Maximum (Peak) Plasma Drug Concentration (Cmax) of REC-4881 (Day 1 through Day 43)
  • Part 1: Time to Reach Cmax (Tmax) of REC-4881 (Day 1 through Day 43)
  • Part 1: Area Under the Plasma Concentration-time Curve (AUC) of REC-4881 (Day 1 through Day 43)
  • Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 through up to Week 37)
  • Part 2: Number of Participants With Dose-limiting Toxicities (DLTs) (First 28 days of treatment)

NCT05552755 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials