AI CT Tool for Early Pulmonary Fibrosis Detection Enters Phase 3, With Eric White, MD

Brainomix announced on January 20, 2026, that Boehringer Ingelheim has selected them to provide quantitative, automated high-resolution CT (HRCT) imaging biomarkers as a co-primary endpoint in the Phase 3 DROP-FPF study.

Early identification remains one of the most persistent challenges in interstitial lung disease and pulmonary fibrosis, where patients are often diagnosed after irreversible lung damage has already occurred. DROP-FPF aims to shift that paradigm by studying whether intervening earlier with nerandomilast, before symptoms and measurable lung function decline, can meaningfully alter the disease trajectory.

In an interview with HCPLive, Eric White, MD, global clinical development lead for rheumatology and pulmonology at Boehringer Ingelheim Pharmaceuticals, emphasized the unmet need this trial addresses.

“That there are no approved options for these individuals, and quite honestly, we're not entirely certain what to do with them,” White said. “When we see them, we tell them, ‘you might have something there, and it might turn into a disease later on,’ but we can't give them much more than that, and so this is one of the first studies to let us start to understand what that aspect of the disease, the very, very, very early disease, how that behaves, and whether intervention with a known, effective medication will improve their outcomes.”

DROP-FPF is a phase 3b randomized, placebo-controlled trial evaluating the safety and effectiveness of nerandomilast (Jascayd) in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis. A defining feature of DROP-FPF is its use of automated, quantitative high-resolution CT (HRCT) imaging biomarkers as a co-primary endpoint, which is the first phase 3 interstitial lung disease trial to do so.

White noted that imaging changes typically precede declines in forced vital capacity (FVC), the standard physiologic endpoint used in pulmonary fibrosis trials. As therapies improve and FVC decline becomes more modest, relying on lung function alone may no longer be sufficient to detect meaningful treatment effects.

“The nice thing about using a quantitative HRCT is that the computers can see changes in the images well before the human eye can,” White said.

The trial will use Brainomix’s FDA-cleared e-Lung platform to quantify metrics, including the reticular vascular score and total disease extent, providing a granular view of early structural changes. White pointed to growing evidence that quantitative CT changes predict lung function decline, mortality, and overall outcomes, supporting their clinical relevance.

DROP-FPF will enroll approximately 80 participants using a rolling enrollment design, with each individual followed for ≥ 2 years. Beyond imaging progression, investigators will track symptom development, including cough, dyspnea, and fatigue, to better define when early interstitial lung disease becomes clinically apparent. Although the study is not expected to change practice immediately, White said it could provide critical evidence supporting earlier identification, closer monitoring, and earlier intervention, laying the groundwork for a more proactive approach to pulmonary fibrosis care.

“We also think [using a quantitative HRCT is] important because, as more and more drugs come to market for treating patients with pulmonary fibrosis, our ability to [detect] the change over time in breathing tests and forced vital capacity is diminishing, so it's going to be harder to determine whether a drug is doing something for a patient purely based on the forced vital capacity,” White said. “The imaging study will show us what parts of the lungs are being destroyed before it impacts the amount of volume that comes out. Because of that, the imaging should give us quite a bit of information before we even get to the point where people are starting to lose lung volumes.”

References

Brainomix e-Lung AI Imaging Technology Selected as Co-Primary Endpoint in Boehringer Ingelheim Phase 3 Clinical Trial in Pulmonary Fibrosis. PR Newswire. Published on January 20, 2026. Accessed on February 5, 2026. https://www.prnewswire.com/news-releases/brainomix-e-lung-ai-imaging-technology-selected-as-co-primary-endpoint-in-boehringer-ingelheim-phase-3-clinical-trial-in-pulmonary-fibrosis-302664595.html