Imaging Biomarkers Detect Nintedanib Effect in INBUILD
New Phase III substudy data show CT-derived markers can track antifibrotic treatment response in patients with lung disease.
Updated on Nov. 2, 2026 in Asthma
Brainomix presented new data from a Phase III INBUILD substudy showing that CT-derived imaging biomarkers detected the treatment effect of nintedanib. The trial was run by Boehringer Ingelheim.
Why it matters
Forced vital capacity is the regulator's primary endpoint, so a imaging-based marker that can identify patients at risk of progression and detect antifibrotic response could offer an additional way to assess treatment in interstitial lung disease.
The evidence comes from a Phase III substudy of the INBUILD trial, with two independent quantitative CT platforms detecting nintedanib's effect. The reticulovascular score from e-Lung alone predicted later mortality, while the study does not report specific effect sizes or sample sizes.
The players
Brainomix
A company that develops AI software for analyzing CT lung imaging, whose e-Lung system is designed to identify interstitial lung diseases and is FDA-cleared.
Boehringer Ingelheim
A German pharmaceutical company that sponsored the Phase III INBUILD trial of nintedanib.
Peter George
A consultant pulmonologist at London's Royal Brompton Hospital who co-authored the INBUILD paper and serves as Brainomix's senior medical director.
The details
Brainomix's Brainomix 360 e-Lung system examines CT scans to quantify pulmonary features in patients with interstitial lung diseases. Peter George, a consultant pulmonologist at London's Royal Brompton Hospital who co-authored the INBUILD paper, is also Brainomix's senior medical director.
Timeline
November 2, 2026: Article reporting the INBUILD biomarker results was published.
Big Picture
The findings sit within the ongoing effort to qualify quantitative imaging as an endpoint for fibrosing lung disease, where FVC has long served as the primary regulatory measure. Biomarker qualification is the next step for Brainomix's FDA-cleared lung AI software, as the field tests whether imaging can complement spirometry.
For people living with interstitial lung disease, the findings suggest that CT-based measures may eventually help clinicians track whether antifibrotic therapy is working alongside standard lung function tests. Any change to routine care would depend on regulatory acceptance of these imaging markers, which has not yet been reported.
The takeaway
Imaging biomarkers may offer a complementary way to measure antifibrotic response beyond FVC, though their role in regulatory decisions still needs to be established.
Further reading
For related context on respiratory conditions, see the Asthma section.
Source note: This article includes information reported by Insights.
