London, UK – March 25, 2024
Clinical Milestone Achieved
BenevolentAI has announced positive safety results from its Phase Ia, first-in-human clinical trial of BEN-8744, a novel PDE10 inhibitor developed for the treatment of moderate to severe ulcerative colitis (UC). The study confirmed BEN-8744’s favorable safety profile, with no serious adverse events (SAEs) or central nervous system (CNS)-related side effects observed.
Promising Pharmacokinetics for Future Development
Pharmacokinetic data from the study supports a twice-daily dosing regimen, optimizing PDE10 target engagement. These results reinforce BEN-8744’s potential to become a first-in-class treatment. Phase II-enabling studies are currently underway.
AI-Driven Discovery and Differentiation
Using its proprietary AI platform, BenevolentAI identified PDE10 inhibition as a novel therapeutic approach for UC. BEN-8744 was engineered to avoid CNS penetration while retaining anti-inflammatory properties, thus overcoming safety issues seen with previous PDE10 inhibitors.
Phase Ia Study Details
The Phase Ia trial
(NCT06118385)
was a randomized, double-blind, placebo-controlled, single-center study assessing both single and multiple ascending doses (SAD/MAD) of BEN-8744 in healthy volunteers aged 18–65.
Key highlights:
- The primary objectives were to evaluate safety, tolerability, and pharmacokinetics
- In the MAD portion, participants received twice-daily doses for 14 days
- The study enrolled 54 participants, with:
- 36 receiving BEN-8744 in the SAD phase
- 12 in the MAD phase
- 6 in a food-effect study
Executive Perspective
Dr. Anne Phelan, Chief Scientific Officer, stated:
“BEN-8744’s strong safety profile supports its potential as a differentiated UC treatment, addressing a critical unmet need in achieving sustained remission.”
Dr. Joerg Moeller, Chief Executive Officer, added:
“These results align with our strategic vision to develop safe, effective treatments. As we finalize Phase II preparations, we remain committed to advancing BEN-8744’s potential.”
About BenevolentAI
BenevolentAI is a leader in AI-driven biomedical research. The company uses artificial intelligence to unlock complex biological insights, accelerate drug discovery, and build a portfolio of innovative drug candidates. Headquartered in London, BenevolentAI also operates a research center in Cambridge, UK, and maintains an office in New York.
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