Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis

Summary

A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.

Timeline

Start

2020-03-03

Primary completion

2023-02-01

Completion

2023-02-15

Outcome

Met primary endpoint

release “The trial met its primary and secondary endpoints demonstrating that PLN-74809 was well tolerated over a 12-week treatment period” pliantrx.com ↗

release “positive safety and efficacy data from the INTEGRIS-IPF Phase 2a trial. The trial met its primary endpoint demonstrating that PLN-74809 was well tolerated” pliantrx.com ↗

Publications

• Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.

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

Indications