New partnership between PhaseV and Crohn’s & Colitis Foundation leverages AI and RWD to transform IBD trials

The Crohn’s & Colitis Foundation and PhaseV have announced a new partnership to enhance clinical trial design and execution for inflammatory bowel disease (IBD) through the use of advanced AI and real-world data (RWD) analytics. The collaboration is intended to support more flexible, data-driven approaches that better reflect the complexity of IBD and improve treatment development.

The initiative combines PhaseV’s artificial intelligence and machine learning (AI/ML) platform with the Foundation’s IBD Plexus® research accelerator, which houses one of the most comprehensive collections of IBD patient data and biosamples worldwide. By integrating these capabilities, the partnership aims to advance more efficient trial methodologies and enable tailored therapeutic strategies for people living with IBD.

IBD, which includes Crohn’s disease and ulcerative colitis, affects approximately 1 in 100 Americans and presents with significant variability in disease presentation, severity, and treatment response. Traditional trial designs often struggle to address this complexity, leading to high failure rates, delayed development timelines, and less effective treatments. According to PhaseV CEO and Co-founder Raviv Pryluk, PhD:

“IBD is a complex disease that demands new approaches to research and development. We are proud to partner with the Crohn's & Colitis Foundation, reflecting our commitment to addressing the most pressing challenges in IBD therapy development to deliver more effective treatments for patients. Together, we aim to create a more efficient path toward safe and effective IBD treatments.”

Designing effective trials for IBD therapies often requires addressing multiple factors, including disease subtype, severity, location, immune response, and genetic background. Fixed trial designs based on initial assumptions may struggle to accommodate this complexity, potentially leading to missed signals, delays, and lower success rates.

Through this collaboration, the Crohn’s & Colitis Foundation and PhaseV will apply a data-driven approach that supports adaptive trial design. Using IBD Plexus’ longitudinal data and biosamples alongside PhaseV’s AI/ML tools, sponsors can assess accumulating data in real time and adjust trials accordingly. This approach aims to enhance trial efficiency and improve the likelihood of identifying treatments that are better aligned with patient needs.

Angela Dobes, Senior Vice President of IBD Plexus at the Crohn’s & Colitis Foundation, emphasized the significance of the partnership:

“We are committed to breaking down barriers in clinical development to drive transformative progress for the IBD community. By leveraging the unparalleled breadth of IBD Plexus' data alongside PhaseV's cutting-edge AI and machine learning platform, we aim to transform trial design and patient recruitment, expediting timelines and advancing more tailored solutions to improve outcomes for IBD patients.”

In addition to supporting adaptive trial execution, PhaseV’s platform includes tools for causal disease modeling, enabling the identification of biomarker-outcome relationships. The company reports that its technology has been used to reduce clinical trial costs by 50%, decrease trial size and duration by 40%, and increase the probability of success by over 30%.