Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Phase 2 Completed 121 enrolled Pliant Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

Timeline

Start: 2020-07-27
Primary completion: 2024-02-26
Completion: 2024-03-18

Outcome

Met primary endpoint

release “The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period” pliantrx.com ↗

Publications

Hirschfield GM, Kowdley KV, Trivedi PJ, Eksteen B, Hameed B, Vincent C, Chen T, Goel A, Reddy KG, Orman E, Joshi D, Lefebvre EA, Schaub JR, An MC, Clark A, Barnes CN, Pencek R, Thorburn D, Montano-Loza AJ, Schramm C, Bowlus CL, Trauner M, Levy C. Phase II INTEGRIS-PSC trial of bexotegrast, an alphavbeta6/alphavbeta1 integrin inhibitor, in primary sclerosing cholangitis. J Hepatol. 2026 Jan;84(1):86-98. doi: 10.1016/j.jhep.2025.09.016. Epub 2025 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bexotegrast	Small molecule	40 mg	Oral
Subject	bexotegrast	Small molecule	80 mg	Oral
Subject	bexotegrast	Small molecule	160 mg	Oral
Subject	bexotegrast	Small molecule	320 mg	Oral