Brainomix’s e-Lung artificial intelligence (AI) imaging technology has been selected by Boehringer Ingelheim as a co-primary endpoint in a pivotal Phase III pulmonary fibrosis trial.

The UK-headquartered company boasted that the DROP-FPF study (NCT07201922) is the first Phase III interstitial lung disease (ILD) trial to utilize automated, quantitative high-resolution CT (HR-CT) imaging biomarkers in this primary role.

The Phase III trial will investigate Boehringer Ingelheim’s Jascayd (nerandomilast) in individuals with early lung abnormalities and a family history of pulmonary fibrosis, a condition causing irreversible lung damage in millions worldwide.

A key objective of the study is to determine if early intervention can slow disease progression in high-risk patients before significant symptoms or lung damage occur. Currently, such at-risk individuals have no approved treatment options until after symptoms emerge.

“The goal is simple but profound: learn whether acting earlier can change outcomes. Using Brainomix’s advanced HRCT algorithms to define meaningful progression, we aim to generate insights that could transform how and when to intervene,” said Martin Beck of Boehringer Ingelheim.

Quantifying Subtle Disease Changes

Brainomix’s US Food and Drug Administration (FDA) cleared e-Lung software uses AI to analyze HR-CT scans, providing objective measurements of fibrosis extent and severity. This allows detection of subtle disease progression even when patients appear clinically well.

“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,” said Professor Peter George Consultant Pulmonologist at the Royal Brompton Hospital, UK, and Brainomix Senior Medical Director.

The trial will be delivered in partnership with AI imaging specialist Voiant. The collaboration combines Brainomix’s biomarkers with Voiant’s centralized image management, aiming to deliver higher-precision respiratory endpoints with greater speed and reliability.

The DROP-FPF study

Jascayd is approved by the US FDA for treating both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).

The placebo-controlled, exploratory Phase III DROP-FPF study is expected to enroll about 80 participants who are first-degree relatives (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis [IPF], idiopathic nonspecific interstitial pneumonia [NSIP], and/or pulmonary fibrosis due to a known genetic cause.

The trial’s primary endpoint is time to physiologic or radiologic worsening of ILA/ILD over the whole trial. It is measured as a relative decline in forced vital capacity (FVC) percentage predicted of more than ten percent from baseline. Alternatively, it is an absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted of more than 10% from baseline or an absolute increase in weighted reticulovascular score (wRVS) of more than two percent and total disease extent (TDE) of more than 2.5% on chest high-resolution computed tomography (HR-CT), as measured by e-Lung Quantitative HRCT scoring, from baseline.

Participants in the study will be involved for approximately 2 to 3 years. They would visit the study site multiple times, with more frequent visits during the first two years (roughly every three months), and then every six months afterward. In the third year, participants also have phone calls with the site staff every three months.

Doctors will regularly conduct lung function tests and perform chest scans to monitor the effectiveness of the treatment. The results from the two groups are compared to determine if nerandomilast is beneficial.