PhaseV, a pioneer in software and machine learning (ML) for clinical trial optimization, announced today it has entered a strategic partnership with Alimentiv Inc., a global GI (gastrointestinal) contract research organization (CRO), to support the optimal design and execution of advanced adaptive clinical trials for a range of GI conditions. These trials will focus on inflammatory bowel disease (IBD), celiac disease, eosinophilic gastrointestinal disease (EGID) and other related disorders.

The collaboration has the potential to accelerate the development of new GI therapies by leveraging adaptive trial methodologies that improve efficiency and outcomes for patients facing these challenging conditions.

"Gastrointestinal diseases are on the rise, contributing to hundreds of thousands of deaths and costing an estimated $136B annually in the U.S. alone," said Pierre Gaudreault, CEO of Alimentiv. "By combining our expertise in GI with PhaseV's advanced machine learning capabilities for trial simulation, design and execution, we intend to significantly improve clinical study efficiency and outcomes. This will accelerate success for our sponsors and help address the growing burden of GI diseases more effectively."

Designing and executing randomized control trials (RCTs) in the field of GI presents significant challenges. These include patient heterogeneity, high placebo response rates in conditions like inflammatory bowel disease, rising study costs, and lengthy trial timelines, all of which place strain on trial sponsors and hinder the discovery of new treatments. Advanced trial designs, such as adaptive designs, can help overcome these challenges by leveraging accumulating data throughout a trial to optimize design and execution.

The collaboration incorporates PhaseV's proprietary adaptive clinical trial technology with Alimentiv's full-service GI CRO service offerings. The solution enables the optimal design of adaptive trials to meet the needs of these studies with seamless execution, helping pharmaceutical and biotech companies overcome the inherent challenges of current designs.

"GI clinical trials have historically been limited by challenges such as patient variability, complex disease mechanisms and a lack of validated biomarkers. These challenges often complicate efficacy assessments of new treatments and lead to trial failure," said Raviv Pryluk, PhD, CEO and Co-founder of PhaseV. "Aligning our ML platform with Alimentiv's GI trial leadership will help trial sponsors overcome these challenges, enabling more robust trial designs and execution that increase the likelihood of success."