AI-generated from publicly available materials.Brainomix is advancing its FDA-cleared e-Lung software towards biomarker qualification, following promising results from Boehringer Ingelheim’s Phase III INBUILD trial.
Recent findings from a substudy involving 474 patients indicate that CT-derived imaging biomarkers can effectively identify individuals at risk of disease progression and assess the efficacy of antifibrotic treatments. The study highlighted that both the e-Lung system from Brainomix and a research algorithm from UCLA successfully detected the benefits of nintedanib over a placebo at multiple time points, specifically at 24 and 52 weeks. Additionally, it established that baseline CT scores could predict a quicker decline in forced vital capacity (FVC), a critical measure used by regulators.
Notably, the e-Lung system uniquely identified that a reticulovascular score at week 24 could forecast later mortality, with scores of 15% or higher correlating with significantly increased risk. The findings underscore the importance of FVC as a primary endpoint in regulatory assessments, reinforcing the potential utility of these biomarkers in clinical settings.
This development is significant as it positions Brainomix to pursue biomarker qualification, a step that could enhance the clinical applicability of its AI software in managing interstitial lung diseases. As the industry moves towards more personalized treatment approaches, the integration of such biomarkers could lead to improved patient outcomes and more informed therapeutic decisions.