Brainomix AI Imaging Detects Significant Antifibrotic Effects of Taladegib in Phase 2a IPF Trial
核心洞察
Brainomix (搜索) and Endeavor BioMedicines (搜索) presented post-hoc AI quantitative CT imaging results from the 12-week Phase 2a ENV-IPF-101 trial of taladegib in idiopathic pulmonary fibrosis (搜索) at the ERS Congress in Barcelona.
Taladegib-treated patients gained an average of 204 mL in lung volume versus a 60 mL decrease with placebo (P = 0.003), alongside significant reductions in total disease extent and fibrosis severity.
The Brainomix (搜索) 360 e-Lung platform detected statistically significant treatment effects in a small 34-patient cohort over a short treatment duration, supporting AI-derived endpoints for pulmonary fibrosis (搜索) drug development.
A post-hoc quantitative imaging analysis has detected statistically significant improvements in lung structure among patients with idiopathic pulmonary fibrosis (搜索) (IPF) treated with Endeavor BioMedicines (搜索)' investigational hedgehog pathway inhibitor taladegib, according to results presented at the 2026 European Respiratory Society (ERS) Congress in Barcelona.
The analysis, conducted under a collaboration between Endeavor BioMedicines (搜索) and AI imaging developer Brainomix (搜索), applied the Brainomix 360 e-Lung platform to high-resolution computed tomography (HRCT) data from the 12-week, randomized, double-blind, placebo-controlled Phase 2a ENV-IPF-101 trial. The study enrolled 34 participants, with 15 patients receiving taladegib (ENV-101) and 19 receiving placebo.
Quantitative Imaging Outcomes
The e-Lung analysis identified significant positive differences in favor of taladegib across three radiographic measures: lung volume, overall interstitial lung disease (ILD) burden, and total fibrosis extent.
Patients treated with taladegib demonstrated an average lung volume increase of 204 mL, compared with a 60 mL decrease in the placebo group (P = 0.003). Total disease extent (TDE) fell by a mean of 2.9% in the taladegib group versus a 1% increase with placebo (P = 0.012). The mean change in the reticulovascular score (RVS), a measure of fibrosis severity, decreased by 0.7% in taladegib-treated patients, while the placebo group recorded a 0.5% increase (P = 0.039).
The trial had previously shown that taladegib improved lung function from baseline as measured by forced vital capacity (FVC), increased total lung capacity, and reversed measures of ILD from baseline at Week 12.
Rationale for AI-Derived Endpoints
According to the investigators, the findings highlight the potential of AI-powered quantitative imaging to support detection of meaningful treatment effects in small, relatively short clinical studies, enabling more efficient and informed clinical development. While FVC remains an established clinical endpoint, the authors note it may not fully capture meaningful biological changes or provide mechanistic insight into treatment response. As background therapies reduce measurable declines in lung function, increasingly sensitive CT quantification may help detect subtle treatment effects.
Brainomix (搜索) 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 to aid clinicians in diagnostic assessment of lung disease. Trained on diverse datasets, the platform has been employed in several Phase 2 and Phase 3 trials and became the first quantitative CT imaging platform selected as a co-primary endpoint in a Phase 3b pulmonary fibrosis (搜索) trial.
Investigator Commentary
"The results of Brainomix (搜索)'s post hoc quantitative imaging analysis continue to support taladegib's potential to improve lung structure, reduce fibrosis and improve lung function in patients with IPF," said Dr. Lisa Lancaster, Chief Medical Officer at Endeavor BioMedicines (搜索). "We are impressed with the technology's ability to detect statistically significant changes in a small cohort and over a short treatment duration. These results are a testament to the value of objective, sensitive and reliable endpoints for the de-risking of clinical development, and we look forward to future collaboration opportunities with Brainomix."
Professor Peter George, consultant pulmonologist at the Royal Brompton Hospital, UK, and Senior Medical Director at Brainomix (搜索), who presented the analysis, added: "Our goal is to accelerate the clinical development of potentially transformational treatments, and taladegib is one of the most promising therapies for pulmonary fibrosis (搜索) currently in development. We are very pleased to see that our analysis with e-Lung was able to provide key insights into the efficacy and mechanism of taladegib. Quantitative CT imaging offers a powerful approach to support earlier, faster, and more informed development decisions, ultimately helping promising therapies reach patients sooner."
Disease Context and Mechanism
IPF is a progressive lung disease affecting more than 150,000 individuals in the United States, with limited treatment options and poor prognosis. Taladegib works by inhibiting the Hedgehog signaling pathway (搜索), which may help resolve the excessive wound-healing processes that lead to fibrosis.
The positive imaging results have catalyzed further collaboration between Brainomix (搜索) and Endeavor BioMedicines (搜索), with the aim of incorporating quantitative image analysis into the continued clinical development of taladegib for pulmonary fibrosis (搜索).