Brainomix's Phase III INBUILD® Study Insights
In a significant advancement for the treatment of progressive pulmonary fibrosis (PPF), Brainomix, a leader in AI-driven medical imaging, has published new findings in the
American Journal of Respiratory and Critical Care Medicine (AJRCCM). The study evaluated data from 474 patients included in Boehringer Ingelheim's Phase III INBUILD® HRCT sub-study, marking it as the largest prospective assessment of quantitative CT in PPF to date.
This groundbreaking research utilized Brainomix's cutting-edge e-Lung software to analyze quantitative CT measures, demonstrating how these metrics can effectively gauge the impact of treatment with nintedanib over time. Notably, the findings indicate that changes in quantitative CT were linked to a marked decline in Forced Vital Capacity (FVC) at 24 and 52 weeks, underscoring the role of quantitative CT as a potential biomarker in clinical trials.
Key Findings
The study provides valuable evidence backing the effectiveness of quantitative CT measures, which were sensitive to treatment effects. More specifically, the data revealed:
- - Sensitivity to Treatment: E-Lung Total Disease Extent (TDE) showed significant changes after 24 and 52 weeks of treatment, highlighting its responsiveness to nintedanib.
- - Correlating Factors: Higher baseline measures of TDE, Reticulovascular Score (RVS), and Weighted Reticulovascular Score (WRVS) correlated with accelerated rates of FVC decline over the study period.
- - Innovation in Clinical Assessments: This research aligns two innovative quantitative CT methodologies—the UCLA QLF/QILD research algorithms and Brainomix e-Lung software—confirming their applicability in the same dataset.
Professor Anand Devaraj, a Consultant Thoracic Radiologist and Medical Director at Brainomix, emphasized that these results reinforce the hypothesis that quantitative CT could serve as a critical complement to traditional measures like FVC. This capability is crucial for tracking disease progression in clinical practice.
Implications for Clinical Trials
These findings suggest that incorporating quantitative CT could significantly enhance clinical trial design by allowing for more nuanced evaluations of treatment efficacy and mechanistic measures of disease activity. By providing real-time insights into lung health, clinicians can better stratify patients and potentially streamline the development of new therapies.
Dr. Susanne Stowasser from Boehringer Ingelheim echoed this sentiment, noting the potential for quantitative CT to enrich the evidence surrounding antifibrotic treatments and improve the understanding of disease trajectories in PPF patients.
About Brainomix
Founded as a spinout from the University of Oxford, Brainomix is revolutionizing medical imaging with AI technology aimed at lung diseases and stroke management. With applications across more than 20 countries, their flagship imaging platforms, including Brainomix 360 Stroke and Brainomix 360 e-Lung, are pivotal in facilitating timely and informed treatment decisions.
For further details about Brainomix and their innovative solutions, visit
Brainomix's website or connect with them on LinkedIn.
This study, however, is not yet evaluated by the FDA, signifying the ongoing exploration into the efficacy of these methods.
In summary, Brainomix’s research paves the way for a transformative understanding of lung disease management, with quantitative CT poised to become a gold standard in clinical assessments of PPF.