A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Completed 41 enrolled Endeavor Biomedicines, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 2, randomized, placebo controlled, multi-center study in subjects with mild to moderate IPF. Eligible subjects will be randomized to receive placebo or ENV-101 as a daily oral dose for 12 consecutive weeks of treatment. Following treatment, subjects will be observed for an additional 6 weeks.

Timeline

Start: 2021-08-26
Primary completion: 2023-11-30
Completion: 2023-11-30

Outcome

Met primary endpoint

paper Between-group differences in change from baseline to week 12 favoured taladegib for the efficacy measures of percent predicted FVC (3·95% [95% CI 0·31-7·60]; p=0·035 PMID 41043447 ↗

Publications

Maher TM, Goldin JG, Hood J, Pitman J, de Los Rios M, Hobbs BP, Yu-Lin AB, Buendia-Roldan I, Thien F, Song JW, Perea PC, Ramirez-Rivera A, DiFrancesco A. Taladegib for the treatment of idiopathic pulmonary fibrosis (ENV-IPF-101): a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Respir Med. 2025 Nov;13(11):1001-1010. doi: 10.1016/S2213-2600(25)00239-5. Epub 2025 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Taladegib	Unknown	200 mg	Oral