AI-enabled drug discovery and development company BenevolentAI (Euronext Amsterdam:BAI) on Monday reported positive safety data from the Phase Ia clinical trial of BEN-8744 in healthy volunteers.

BEN-8744, an orally administered PDE10 inhibitor, demonstrated safety and tolerability with no serious adverse events reported across all dose cohorts. Importantly, the study showed no evidence of central nervous system (CNS)-related adverse events, addressing concerns seen in previous PDE10 inhibitors.

Pharmacokinetic data suggested that twice daily dosing achieves the desired PDE10 target coverage, indicating potential efficacy for patients with moderate to severe ulcerative colitis (UC). Identified through the Benevolent Platform, PDE10 inhibition presents a novel approach for UC treatment with possible differentiation from standard-of-care options. BEN-8744's design as a peripherally-restricted molecule minimises CNS penetration, further mitigating potential side effects.

Future developments include presenting full study results in a peer-reviewed forum and conducting Phase II-enabling toxicology studies and biomarker qualification.

With its unique mechanism of action, BEN-8744 holds promise for broader inflammatory bowel disease indications, supported by preclinical data indicating significant anti-inflammatory effects in Crohn's disease.