Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis
Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF.
'These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease,' said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. 'We are grateful to the Qureight team for partnering with us on this important analysis.'
The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18).
Key Results from the Post Hoc Analysis Presented at ATS 2025
Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87).
Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64).
Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28).
'We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8,' said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. 'Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight's deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine.'
About the ENV-101 Phase 2a Clinical Trial
Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile.
About the WHISTLE-PF Trial
Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (W ound-remodeling H edgehog-Inhibitor I LD S tudy T esting L ung Function E ndpoints- PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound's safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT.
About Idiopathic Pulmonary Fibrosis
IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis.
About ENV-101
Endeavor BioMedicines' investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function.
About Endeavor BioMedicines
Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at www.endeavorbiomedicines.com and on LinkedIn or X.
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