BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

Regulatory News:

BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

• BEN-8744 is an orally administered, peripherally-restricted PDE10 inhibitor being developed as a potential first-in-class treatment for patients with moderate to severe ulcerative colitis (UC)
• The Phase Ia study met its primary objective. BEN-8744 was safe and well tolerated, with no Serious Adverse Events (SAEs) reported in any dose cohorts. Importantly, given the liabilities associated with PDE10 inhibitors previously in clinical development for other central nervous system (CNS) indications, there was no evidence of CNS-associated adverse events
• The pharmacokinetic profile of BEN-8744 generated in the study suggested that twice daily dosing should achieve the desired PDE10 target coverage to elicit a potential therapeutic effect in subsequent clinical studies in UC patients
• PDE10 was identified using the Benevolent Platform^TM as a novel drug target for the treatment of UC with potential for meaningful differentiation versus existing standard-of-care treatments

BenevolentAI, using the Benevolent Platform^TM, identified PDE10 inhibition as a potential novel approach to treat UC, but was aware of CNS side effects with PDE10 inhibitors in development for CNS indications that limited their further clinical development. As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e. with very limited CNS penetration, to minimise the chances of these side effects occurring. The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level. It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date. Phase II-enabling extended regulatory toxicology studies and biomarker qualification studies are underway to permit the extended dosing envisaged for further drug development.