Endeavor BioMedicines Reports Positive Quantitative Imaging Results for Taladegib in Idiopathic Pulmonary Fibrosis
Endeavor BioMedicines, a clinical-stage biotechnology company focused on developing medicines with the potential to deliver transformational benefits to patients with life-threatening diseases, has announced new quantitative imaging findings from its Phase 2a clinical trial evaluating investigational therapy taladegib (ENV-101) in patients with idiopathic pulmonary fibrosis (IPF).
The post hoc analysis demonstrated significant improvements in lung volume among patients treated with taladegib, along with significant reductions in total disease extent and quantitative measures of fibrosis severity. The findings were presented during a poster session at the European Respiratory Society (ERS) Congress 2026 in Barcelona, Spain.
The analysis adds to the growing body of clinical and imaging evidence surrounding taladegib and its potential role in treating pulmonary fibrosis. By applying artificial intelligence (AI)-powered quantitative imaging technology to high-resolution computed tomography (HRCT) scans, researchers were able to assess structural changes in the lungs following treatment.
According to Endeavor, the findings are consistent with previously reported HRCT analyses conducted using other quantitative imaging platforms. The company believes the collective results provide further support for the potential of taladegib to influence lung function and structure while reducing measures associated with fibrosis in patients with IPF.
Quantitative Imaging Provides Additional Evidence
The post hoc analysis used Brainomix’s e-Lung AI-powered imaging platform to examine HRCT scans collected at baseline and following 12 weeks of treatment. The technology enabled researchers to quantify several imaging biomarkers associated with lung volume, interstitial lung disease (ILD) burden and fibrosis severity.
A total of 34 participants from the Phase 2a trial were included in the analysis. Of these participants, 15 received taladegib, while 19 received placebo.
The imaging assessment evaluated several quantitative measures, including lung volume, total disease extent (TDE), reticulovascular score (RVS) and weighted reticulovascular score (WRVS). These measurements are designed to provide objective information about the structural condition of the lungs and the extent and severity of fibrotic disease.
Quantitative CT imaging has become an increasingly important tool in pulmonary fibrosis research because conventional assessments may not fully capture subtle structural changes in the lungs. By analyzing CT images using standardized quantitative methods, researchers can potentially identify changes in disease extent and lung structure that may complement conventional clinical measurements such as forced vital capacity (FVC).
The new analysis provides additional information on how taladegib may affect the physical characteristics of diseased lung tissue.
Taladegib Associated With Increased Lung Volume
One of the most notable findings from the analysis was the difference in lung volume between participants treated with taladegib and those receiving placebo.
Patients in the taladegib group experienced a mean increase in lung volume of 204 milliliters from baseline after 12 weeks of treatment. In comparison, the placebo group experienced a mean decrease of 60 milliliters.
The difference between the treatment groups was statistically significant, with a p-value of 0.003.
The improvement in lung volume is particularly relevant in IPF, a chronic and progressive lung disease characterized by the development of scar tissue within the lungs. As fibrosis progresses, lung tissue can become increasingly stiff, potentially limiting the ability of the lungs to expand and exchange gases efficiently.
A measurable increase in lung volume may therefore provide an additional indicator of potential treatment-associated changes in lung structure. While quantitative imaging results alone cannot establish clinical benefit, the finding provides useful information when considered alongside other clinical and functional measures.
Endeavor noted that similar improvements in lung volume and ILD extent have previously been observed using other quantitative CT analysis platforms, adding consistency to the overall imaging evidence.
Reduction in Total Disease Extent
The analysis also showed a statistically significant reduction in total disease extent among patients receiving taladegib.
Total disease extent is a quantitative measure of the burden of interstitial lung disease identified through imaging. In the taladegib group, mean TDE decreased by 2.9% from baseline. In contrast, participants in the placebo group experienced a mean increase of 1.0%.
The difference between the two groups was statistically significant, with a p-value of 0.012.
The reduction in TDE suggests that patients treated with taladegib experienced a measurable decrease in the amount of lung affected by the disease over the 12-week treatment period, based on the quantitative imaging assessment.
This finding is notable because IPF is generally associated with progressive accumulation of fibrotic changes in lung tissue. Consequently, an imaging-based reduction in disease extent may provide an important signal for further investigation.
However, because the analysis was post hoc and involved a relatively small patient population, additional clinical studies will be needed to determine the reproducibility and significance of these observations.
Fibrosis Severity Measures Also Improved
In addition to lung volume and overall disease extent, the analysis evaluated measures intended to quantify the severity of fibrosis.
Patients receiving taladegib demonstrated a mean reduction of 0.7% in RVS from baseline, compared with a 0.5% increase in the placebo group. The difference was statistically significant, with a p-value of 0.039.
RVS is a quantitative imaging measurement used to assess the extent of fibrotic changes within the lungs. The reduction observed in the taladegib group suggests a potential decrease in the quantitative severity of fibrosis over the treatment period.
The analysis also showed a favorable numerical change in WRVS. Mean WRVS decreased by 0.5% from baseline in the taladegib group, compared with an increase of 0.6% in the placebo group.
WRVS provides an assessment of peripheral fibrosis severity and was also used to evaluate whether the treatment and placebo groups were appropriately balanced at baseline.
At the beginning of the study, mean WRVS was 15.5% in the taladegib group and 14.2% in the placebo group, indicating that the groups were generally well matched according to this measure.
A baseline WRVS of 15 or higher has been associated with an increased risk of FVC decline, according to the analysis presented by Endeavor.
AI Technology Supports More Detailed Assessment
Brainomix’s e-Lung platform played a central role in the post hoc analysis by applying AI-based image analysis to HRCT scans.
Quantitative imaging approaches can help researchers transform complex radiological images into measurable biomarkers. In diseases such as IPF, where structural changes can be distributed throughout the lungs, automated quantitative assessment may provide additional information beyond visual interpretation.
The use of e-Lung allowed investigators to assess changes in multiple imaging parameters simultaneously. This included the amount of lung affected by disease, overall lung volume and quantitative measures associated with fibrosis.
Peter George, M.B.B.S., Ph.D., Consultant Pulmonologist at Royal Brompton Hospital in the United Kingdom, Senior Medical Director at Brainomix and presenting author of the analysis, said the findings demonstrate the potential value of quantitative CT imaging in drug development.
“Our goal is to accelerate the clinical development of potentially transformational treatments, and taladegib is one of the most promising therapies for pulmonary fibrosis currently in development,” George said.
He added that the e-Lung analysis provided significant insights into the potential efficacy and mechanism of taladegib.
According to George, quantitative CT imaging can support earlier and more informed decisions during drug development by providing objective measurements of structural changes in diseased tissue.
Consistency Across Imaging Approaches
A key aspect of the latest findings is their consistency with earlier quantitative imaging analyses conducted using other platforms.
Endeavor believes that seeing similar changes across independent imaging approaches strengthens the overall evidence supporting taladegib’s potential biological effects.
Lisa Lancaster, M.D., Chief Medical Officer of Endeavor BioMedicines, emphasized the consistency between the imaging findings and previously observed lung-function results from the Phase 2a trial.
“We are encouraged by the consistency between the improvements previously observed in lung function from our Phase 2a trial and the favorable changes seen with quantitative CT assessments of lung volume and fibrosis,” Lancaster said.
She added that findings generated through multiple independent quantitative imaging approaches continue to support the potential of taladegib to address the underlying biology of IPF.
The combination of functional measurements and structural imaging may provide a more comprehensive understanding of how an investigational therapy affects progressive pulmonary disease.
Potential Significance for Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis is a serious and progressive respiratory condition in which scar tissue accumulates within the lungs. As fibrosis advances, normal lung architecture can become increasingly disrupted, potentially resulting in declining respiratory function.
The progressive nature of IPF creates a significant need for treatments that can slow disease progression and potentially influence the underlying fibrotic process.
For drug developers, demonstrating meaningful changes in both lung function and lung structure is an important component of evaluating potential therapies. The latest data from Endeavor provide additional evidence that taladegib may affect several measurable characteristics of pulmonary fibrosis.
The observed increase in lung volume, reduction in total disease extent and decrease in RVS collectively suggest favorable structural changes following taladegib treatment. Nevertheless, these results are based on a post hoc analysis of a relatively small group of participants and should be interpreted in the context of the broader clinical development program.
Supporting Further Development of Taladegib
The new data presented at ERS Congress 2026 add another layer to Endeavor’s evaluation of taladegib in IPF. The company is using multiple forms of evidence to investigate the potential effects of the investigational therapy, including clinical assessments, lung-function measurements and quantitative imaging.
The findings from the e-Lung analysis provide additional support for continued evaluation by showing measurable changes in lung structure after 12 weeks of treatment.
Importantly, the consistency of findings obtained through different quantitative CT platforms may help increase confidence in the reproducibility of the observed imaging signals. Continued research will be necessary to determine whether these structural changes persist over longer periods and whether they translate into meaningful improvements in patient outcomes.
The Phase 2a data and associated imaging analyses will also help inform the design and evaluation of future clinical studies.
The presentation of the quantitative imaging analysis at the ERS Congress represents an important development in Endeavor BioMedicines’ clinical program for taladegib.
Across the 34 participants included in the post hoc analysis, treatment with taladegib was associated with a statistically significant increase in lung volume compared with placebo, as well as a significant reduction in total disease extent. The therapy also produced a statistically significant reduction in RVS, while WRVS showed a favorable numerical trend.
The use of Brainomix’s AI-powered e-Lung platform enabled researchers to quantify these changes through detailed analysis of HRCT scans collected at baseline and after 12 weeks.
While further clinical investigation is required, the results contribute to an expanding set of findings suggesting that taladegib may have the potential to influence both lung function and structural manifestations of fibrosis.
For patients with IPF, new therapeutic approaches capable of addressing the underlying mechanisms of progressive fibrosis remain an important area of research. Endeavor intends to continue advancing taladegib while using clinical and quantitative imaging data to better understand its potential benefits.
The latest results underscore the growing role of AI-assisted quantitative imaging in pulmonary drug development and provide additional evidence supporting further study of taladegib as a potential treatment for idiopathic pulmonary fibrosis.
About Idiopathic Pulmonary Fibrosis
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 Taladegib
Endeavor BioMedicines’ investigational medicine taladegib (ENV-101) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, taladegib eliminates 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, taladegib (ENV-101), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis.