This daily pill may boost lung function in IPF patients, trial shows

An experimental oral treatment called taladegib helped expand lung volume and reduce scarring in people with idiopathic pulmonary fibrosis (IPF), according to a new imaging analysis from a clinical trial.

Data from the Phase 2a trial (NCT04968574), generated using artificial intelligence (AI) to evaluate high-resolution chest scans, were presented recently at the European Respiratory Society Congress in Barcelona, Spain. These imaging results build on earlier data showing that the investigational drug may improve overall lung function.

“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,” Lisa Lancaster, MD, chief medical officer of developer Endeavor Biomedicines, said in a company press release.

IPF is a progressive lung disease of unknown cause marked by scar tissue buildup in the lungs. As scar tissue accumulates, the lungs grow stiffer, making it harder for them to expand and deliver oxygen into the bloodstream. This damage leads to chronic symptoms such as shortness of breath, a persistent cough, and fatigue.

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How taladegib targets lung scarring

This scarring is driven in part by overactive myofibroblasts — specialized cells that normally help heal wounds but produce excess scar tissue when hyperactive. Their activity is regulated by the Hedgehog molecular signaling pathway, which plays a role in tissue repair.

Taladegib (ENV-101) is a daily pill designed to block this Hedgehog signaling to clear out scar-producing myofibroblasts.

The Phase 2a trial included 41 adults with IPF, 40 and older, who were not taking other IPF medications. Participants received either 200 mg of taladegib or a placebo daily for 12 weeks.

Earlier results from the study found that taladegib was generally well tolerated and associated with improvements in lung function and reductions in fibrosis measures compared with the placebo.

The new analysis utilized Brainomix’s e-Lung AI platform, an automated imaging tool that processes high-resolution CT scans, comparing patient lungs before treatment and after 12 weeks. This analysis evaluated 15 participants on taladegib and 19 on the placebo.

After 12 weeks, average lung volume increased by 204 mL in the taladegib group, compared to a 60 mL decrease in the placebo group — a statistically significant difference.

Taladegib treatment also led to a 2.9% reduction in total disease extent, a measure tracking the overall percentage of damaged lung tissue. Meanwhile, placebo recipients experienced a 1% increase. Additionally, the reticulovascular score, which measures overall fibrosis severity, dropped by 0.7% with taladegib while rising by 0.5% with the placebo. These differences were also statistically significant.

“Taken together, findings generated across multiple independent quantitative imaging approaches continue to support taladegib’s potential to help patients with IPF by addressing the underlying biology of disease,” Lancaster said.

Next steps for taladegib in IPF

The analysis stems from a partnership between Brainomix and Endeavor to integrate quantitative imaging analysis into the clinical development of taladegib.

“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,” Peter George, PhD, senior medical director at Brainomix, said in another press release. “Quantitative CT imaging offers a powerful approach to support earlier, faster, and more informed development decisions, ultimately helping promising therapies reach patients sooner.”

An ongoing Phase 2b study called WHISTLE-PF (NCT06422884) is now testing taladegib in 213 adults with IPF across 78 international sites. Unlike the earlier trial, participants taking standard-of-care IPF treatments may join.

Participants will receive one of three taladegib doses or a placebo daily for about six months. The trial’s primary goal is to evaluate the effect of treatment on percent predicted forced vital capacity, a measure of lung function that reflects the maximum amount of air a person can exhale in a single forceful breath.

Secondary outcomes will evaluate other lung function metrics, symptom changes using the Living with Pulmonary Fibrosis Symptoms Questionnaire, and high-resolution CT imaging to track ongoing changes in lung function and fibrosis.