Brainomix e-Lung AI Imaging Technology Selected as Co-Primary Endpoint in Boehringer Ingelheim Phase 3 Clinical Trial in Pulmonary Fibrosis

• The DROP-FPF trial is the first Phase 3 trial in interstitial lung disease (ILD) to use automated, quantitative high-resolution CT scan (HRCT) imaging biomarkers as a co-primary endpoint

OXFORD, England and CHICAGO, Jan. 20, 2026 /PRNewswire/ -- Brainomix, a global leader and pioneer of AI-powered imaging tools in lung fibrosis and stroke, today announced it was selected by Boehringer Ingelheim, the leading biopharmaceutical company providing therapeutic options for interstitial lung disease (ILD), to provide objective, quantitative HRCT imaging biomarkers as a co-primary endpoint in the DROP-FPF Phase 3 study.

DROP-FPF is a Phase 3b double blind, randomized, placebo-controlled study investigating the safety and effectiveness of nerandomilast (Jascayd^®) in individuals with interstitial lung abnormalities (ILA's) and a family history of pulmonary fibrosis. Jascayd^® received FDA approval for both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in late 2025, ushering in a new therapeutic option to help manage these devastating forms of ILD.

The study, set to initiate patient enrollment in January and include a two-year follow-up period, will investigate whether early intervention with nerandomilast slows the progression of early signs of pulmonary fibrosis in people with a family history of the condition. Pulmonary fibrosis causes irreversible lung damage and impacts 3-4 million people worldwide¹. Yet individuals at elevated risk due to family history currently have no approved treatment options until symptoms emerge, often after substantial lung damage has already occurred.

This trial marks the first time that automated, quantitative high-resolution CT (HRCT) imaging biomarkers will serve as a co-primary endpoint in a Phase 3 ILD study. Brainomix's AI-powered e-Lung software will provide objective measurements of fibrosis extent and disease severity by analyzing HRCT scans at baseline and at follow-up timepoints.

Martin Beck, Senior VP and Head of Therapeutic Area Inflammation at Boehringer Ingelheim, commented: "IPF and PPF are serious, progressive lung diseases that can be more life-threatening than some forms of cancer. They progress silently, with early symptoms often dismissed as ageing 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. Using Brainomix's advanced HRCT algorithms to define meaningful progression, we aim to generate insights that could transform how and when to intervene."

Professor Peter George, Consultant Pulmonologist at the Royal Brompton Hospital, UK and Brainomix Senior Medical Director, added: "Accurate and reliable quantification of subtle but clinically meaningful features of disease progression is essential to achieving the objectives of this study. Brainomix e-Lung enables this through validated, proprietary, AI-driven CT biomarkers that accurately quantify physiologically meaningful features of interstitial lung disease. 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. This has the potential to significantly improve clinical trial design."

The AI-powered and FDA-cleared e-Lung software has been trained on large, diverse datasets of patients with various forms of ILD and has been validated in the Phase 3 INBUILD study that originally led to the approval of nintedanib (Ofev^®) in patients with progressive pulmonary fibrosis.

The DROP-FPF study will be delivered in partnership with Voiant – the industry leading AI-based clinical trial imaging solution provider – leveraging Brainomix's advanced imaging biomarkers alongside Voiant's centralized image management and analytics framework.

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

1.    Boehringer Ingelheim, Facts about IPF – Respiratory Disease

About Brainomix

Brainomix is a global pioneer in AI medical imaging, enabling precision medicine for better treatment decisions in stroke and lung fibrosis. Its flagship product, Brainomix 360 Stroke, is the world's first fully automated AI-imaging platform, designed for acute stroke assessment at all points of the patient pathway, facilitating more confident treatment and transfer decisions for patients in all hospitals, regardless of local resources or expertise. Brainomix 360 e-Lung technology applies AI-driven CT biomarkers to identify, monitor, and predict disease progression in pulmonary fibrosis. Founded as a spinout from the University of Oxford, Brainomix has offices in the UK, Ireland and the USA, and operations in more than 20 countries.

To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn, and Facebook.

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