BenevolentAI’s Novel Ulcerative Colitis Treatment Advances to Phase 1a Trial

BenevolentAI, a pioneering artificial intelligence (AI) company, has made significant progress in developing a novel treatment for ulcerative colitis, a chronic inflammatory bowel disease. The company’s chief scientific officer, Dr. Anne Phelan, recently shared positive safety data from the Phase 1a, first-in-human clinical study of BEN-8744 in healthy volunteers.

BEN-8744 is a potent and selective PDE10 inhibitor uniquely designed to be peripherally restricted, mitigating the central nervous system (CNS) side effects associated with previous PDE10 inhibitors. This innovative design aims to ensure safety and tolerability, a primary goal in this phase of clinical research. According to Phelan, the study successfully met its objectives, proving the hypothesis that peripheral restriction could eliminate adverse side effects, although it was not positioned to assess therapeutic value directly.

Phelan further elaborated on the study’s methodology, highlighting its role in estimating the pharmacologically relevant exposure and understanding the drug’s exposure profile, which is critical for determining the efficacious dose for future patient trials. The interview also shed light on BenevolentAI’s innovative platform that integrates diverse data types, including genomics and transcriptomics, through advanced AI and machine learning models.

Remarkably, this platform identified PDE10 inhibition as a novel approach for treating ulcerative colitis, despite the lack of direct literature linking PDE10 to the condition, demonstrating the company’s proprietary method in target discovery.

Looking ahead, Phelan mentioned ongoing Biomarker Qualification studies and extended toxicology studies to pave the way for phase 1b and phase 2 studies, with an emphasis on ensuring longer dosing durations are safe for patients. This step is pivotal for moving BEN-8744 towards clinical efficacy trials, underlining BenevolentAI’s commitment to advancing drug development through AI-enabled insights.

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