Advancements in Early Detection of Pulmonary Fibrosis
On January 20, 2026, Brainomix announced an exciting partnership with Boehringer Ingelheim to utilize advanced quantitative, automated high-resolution CT (HRCT) imaging biomarkers as a co-primary endpoint in the Phase 3 DROP-FPF study. This collaboration marks a crucial step in addressing the longstanding challenges in the early detection of interstitial lung disease, specifically pulmonary fibrosis.
Detecting this condition early is crucial, as patients are often diagnosed only after significant, irreversible lung damage has occurred. The DROP-FPF study aims to change this trajectory by investigating whether early intervention with nerandomilast can positively influence the disease before symptoms and measurable lung function decline manifest.
Addressing Unmet Needs
In a recent interview with HCPLive, Dr. Eric White, global clinical development lead for rheumatology and pulmonology at Boehringer Ingelheim, highlighted the pressing need for this trial. “Currently, there are no approved treatments for these patients, and unfortunately, we lack clear guidance on how to manage their condition,” he stated. “When we encounter them, we can only say, ‘You might have something, and it could develop into a disease,’ but we are limited in our response. This study is among the first to deepen our understanding of the very early stages of the disease and whether treatment with a proven medication can improve outcomes.”
The Trial and Its Innovative Approach
DROP-FPF is a Phase 3b randomized, placebo-controlled trial examining the safety and efficacy of nerandomilast (Jascayd) in patients exhibiting interstitial lung abnormalities and having a family history of pulmonary fibrosis. Notably, it is the first Phase 3 trial in the field of interstitial lung disease to incorporate quantitative HRCT imaging biomarkers as a co-primary endpoint.
Dr. White noted that changes observed through imaging often occur prior to any decline in forced vital capacity (FVC), the standard physiological endpoint in pulmonary fibrosis trials. “As new therapies evolve and FVC declines become less pronounced, relying solely on lung function may not suffice to detect significant treatment impacts,” he emphasized.
Using quantitative HRCT imaging enables computers to detect subtle changes in lung images long before they become apparent to the human eye. This capability can provide a more definitive assessment of disease progression.
The DROP-FPF trial will leverage Brainomix’s FDA-cleared e-Lung platform, which will quantify various metrics, including the reticular vascular score and total disease extent, yielding a detailed overview of early structural changes in the lungs. Dr. White pointed to accumulating evidence that such quantitative CT changes can predict lung function decline, mortality, and overall patient outcomes, substantiating their clinical relevance.
Study Design and Future Implications
The trial plans to enroll around 80 participants using a rolling enrollment design, with each individual being monitored for at least two years. Alongside tracking imaging progression, researchers will also assess symptom development, including cough, dyspnea, and fatigue, to better delineate when early interstitial lung disease becomes clinically evident. Although immediate practice changes are not anticipated, Dr. White believes this trial could pave the way for earlier identification, closer monitoring, and prompt intervention in pulmonary fibrosis treatment.
“Utilizing quantitative HRCT is essential, especially as more treatments emerge for pulmonary fibrosis. The ability to detect changes over time in breathing tests and forced vital capacity is diminishing, making it increasingly challenging to determine the efficacy of medication based solely on those measurements,” Dr. White explained. “Imaging will reveal which parts of the lungs are deteriorating before any noticeable decline in lung volume occurs. Thus, imaging should provide valuable insights long before patients experience a loss of lung function.”
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