A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients with Lung Fibrosis (WHISTLE-PF Trial)

The purpose of this study is to learn more about the medication ENV-101 by studying the safety and efficacy of ENV-101 tablets for the treatment of Idiopathic Pulmonary Fibrosis (IPF) when the tablet is taken orally as a daily dose for 24 weeks.ENV-101 is an investigational drug that was originally developed as a treatment for patients with advanced cancer. Endeavor Biomedicines (Sponsor of the study) is repurposing the molecule for use in the treatment of IPF. IPF is a form of interstitial lung disease (ILD), which are progressive fibrotic lung scarring diseases that result in loss of lung elasticity, capacity, and function. Current therapeutic options for these diseases are limited to drugs that modestly slow the rate of lung function decrease. Significant advances are urgently needed for patients. This is a randomized, double-blind trial (study doctor and participants won’t know if a participant is receiving ENV-101 or placebo). Participants will be assigned to one of three dose levels of ENV-101 or placebo and will have a 25% chance of receiving placebo.Participants will be required to undergo a HRCT (High Resolution Computed Tomography) scan to examine their lungs. The risk posed by radiation exposure from the scan is considered low. Blood sampling and ECG (electrocardiogram; a recording of heart electrical activity) will also be performed.Approximately 200 patients will take part in the study across 16 countries at approximately 100 sites worldwide. The study duration is approximately 18 months, with participant duration of approximately 7 months.