BenevolentAI (OTC:BAIVF) chief scientific officer Dr Anne Phelan joins Proactive's Stephen Gunnion with positive safety data from the Phase 1a, first-in-human, clinical study of BEN-8744 in healthy volunteers.
Phelan explained that BEN-8744 is a potent, selective PD10 inhibitor, uniquely designed to be peripherally restricted to mitigate CNS-mediated side effects associated with previous PD10 inhibitors. This design aims to ensure safety and tolerability, a primary goal in this phase of clinical research. She said 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 detailed 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.
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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