Brainomix AI Imaging Technology to Serve as Co-Primary Endpoint in Boehringer Ingelheim's Phase 3 Lung Fibrosis Trial

Brainomix has announced that its AI-powered imaging platform, e-Lung, will be used as a co-primary endpoint in a new Phase 3b study led by Boehringer Ingelheim. The trial, known as DROP-FPF, is designed to assess the safety and effectiveness of nerandomilast (Jascayd®) in individuals with interstitial lung abnormalities (ILAs) and a family history of pulmonary fibrosis.

Scheduled to begin patient enrollment in January 2026, the randomized, placebo-controlled study represents a significant shift in the way interstitial lung disease (ILD) progression is measured. It will be the first Phase 3 ILD trial to use automated, quantitative high-resolution CT (HRCT) imaging biomarkers as a co-primary endpoint. Brainomix’s e-Lung software will analyze HRCT scans to provide objective measures of fibrosis extent and disease severity at baseline and during follow-up over a two-year period.

The trial builds on the recent FDA approval of Jascayd® for idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), offering new hope for patients facing these progressive and often fatal lung diseases. ILDs affect an estimated 3 to 4 million people globally, with few therapeutic options available for those at elevated risk who do not yet show symptoms.

Martin Beck, Senior Vice President and Head of the Inflammation Therapeutic Area at Boehringer Ingelheim, highlighted the importance of early intervention.

“IPF and PPF are serious, progressive lung diseases that can be more life-threatening than some forms of cancer,” Beck said. “They progress silently, with early symptoms often dismissed as aging or misdiagnosed. But in a progressive disease, there is no going back. Once fibrosis advances, the damage is irreversible. That's why this study is so important. Our goal is simple but profound: learn whether acting earlier can change outcomes for families facing these devastating diseases.”

The AI-driven biomarkers from Brainomix are expected to improve trial sensitivity by capturing subtle, physiologically relevant changes in lung structure before clinical symptoms or declines in lung function become apparent.

Professor Peter George, consultant pulmonologist at Royal Brompton Hospital and Brainomix’s Senior Medical Director, noted the role of imaging in advancing trial design.

“Accurate and reliable quantification of subtle but clinically meaningful features of disease progression is essential to achieving the objectives of this study,” George said. “Brainomix e-Lung enables this through validated, proprietary, AI-driven CT biomarkers. This information can reveal whether disease biology is changing, even when patients still appear clinically well and have normal lung function, allowing researchers to detect treatment effects far earlier than previously possible.”

The e-Lung platform is FDA-cleared and was previously validated in the INBUILD trial that led to the approval of nintedanib (Ofev®) for PPF. The DROP-FPF study will also involve Voiant, an AI-based clinical trial imaging solutions provider, to support centralized image management and analytics.

“AI-driven quantitative imaging analysis enables more confident detection of treatment effects while improving efficiency through smarter patient selection and optimized trial design,” said Jessica Ataharul, Vice President of Clinical Operations at Voiant. “By combining Brainomix’s advanced imaging biomarkers with Voiant’s independent analytics framework, the study will deliver higher-precision respiratory endpoints with greater speed and reliability.”