Brainomix E-Lung Analysis Detects Treatment Effects in Phase 2a IPF Trial

Brainomix and Endeavor BioMedicines presented positive results on September 8, 2026, from an AI-driven quantitative analysis of CT imaging data collected in Endeavor’s Phase 2a trial of taladegib in idiopathic pulmonary fibrosis, with the findings shown at the European Respiratory Society Congress in Barcelona. According to the joint announcement, the analysis detected significant treatment effects across multiple measures of lung structure and fibrosis.

The underlying study, designated ENV-IPF-101, was a randomized, double-blind, placebo-controlled 12-week trial evaluating taladegib, a hedgehog pathway inhibitor, in patients with IPF. The trial previously demonstrated that treatment with taladegib improved lung function from baseline as measured by forced vital capacity, increased total lung capacity, and reversed measures of interstitial lung disease from baseline at week 12.

The E-Lung Post-Hoc Analysis

Brainomix 360 e-Lung is an FDA-cleared, CE-marked AI-powered image analysis tool that provides automatic quantifications and visualizations of radiographic features in lung CT scans. Clinicians can use these outputs to aid their diagnostic assessment of lung disease. The two companies entered into a collaboration to conduct a post-hoc analysis evaluating whether Brainomix’s AI-powered quantitative imaging outputs could support clinical trials. In the analysis of the 12-week ENV-IPF-101 trial, the companies reported that e-Lung detected significant positive differences in favor of taladegib in lung volume, overall interstitial lung disease burden, and total fibrosis extent.

According to the companies, the findings highlight the potential of AI-powered quantitative imaging outputs to support the detection of meaningful treatment effects in small, relatively short clinical studies, supporting more efficient and informed clinical development. They also framed the results as evidence of the value of reliable, objective AI-derived endpoints in pulmonary fibrosis development programs. While forced vital capacity remains an established clinical endpoint, the announcement states that it may not fully capture meaningful biological changes or provide mechanistic insights into treatment response. As background therapies reduce measurable declines in lung function, the companies said, increasingly sensitive CT quantification may help detect subtle treatment effects and support more data-informed drug development.

The results have catalyzed further collaboration between Brainomix and Endeavor, with the companies aiming to incorporate quantitative image analysis into the continued clinical development of taladegib for pulmonary fibrosis.

Dr Lisa Lancaster, Chief Medical Officer at Endeavor BioMedicines, said the analysis continues to support taladegib’s potential to improve lung structure, reduce fibrosis, and improve lung function in patients with IPF. “We are impressed with the technology’s ability to detect statistically significant changes in a small cohort and over a short treatment duration,” she said, describing the results as a testament to the value of objective, sensitive, and reliable endpoints for de-risking clinical development.

Trial Design and Conference Details

The presentation, titled “Treatment with taladegib results in increased lung volume and regression of markers of ILD: A Phase 2a post hoc CT analysis using Brainomix e-Lung,” was accepted as a late-breaking abstract for the congress, which ran September 5–9, 2026. Peter George, a consultant pulmonologist at the Royal Brompton Hospital in the UK and Senior Medical Director at Brainomix, was the presenting author, according to Endeavor’s presentation announcement.

Endeavor describes IPF as a chronic, progressive lung disease affecting more than 150,000 adults in the United States, with an average life expectancy of three to five years after diagnosis. Taladegib, Endeavor’s lead candidate, is designed to bind to and inhibit a key receptor in the hedgehog signaling pathway, a mechanism the company says eliminates the myofibroblasts that drive fibrosis and may resolve the excessive wound-healing process seen in pulmonary fibrosis.

George said the e-Lung analysis provided key insights into the efficacy and mechanism of taladegib, which he described as one of the most promising therapies for pulmonary fibrosis currently in development. “Quantitative CT imaging offers a powerful approach to support earlier, faster, and more informed development decisions, ultimately helping promising therapies reach patients sooner,” he said.

Broader ERS Presence

Brainomix said it trained e-Lung on diverse datasets and that the platform has already been employed in several Phase 2 and Phase 3 trials. According to the company, e-Lung became the first quantitative CT imaging platform selected as a co-primary endpoint in a Phase 3b pulmonary fibrosis trial.

Alongside the taladegib analysis, Brainomix is presenting four additional studies at ERS 2026 on the potential of quantitative CT to provide objective insights in assessing pulmonary CT scans. Those studies explored assessing interstitial lung disease treatment responses, detecting early disease progression, stratifying mortality risk, and identifying patients at risk of pulmonary hypertension.

Brainomix, founded as a spinout from the University of Oxford, develops AI-powered imaging tools for lung disease and stroke and operates in more than 20 countries, with offices in the UK, Ireland, and the United States.