BenevolentAI has dosed the first patients in Phase I first-in-human studies of its oral phosphodiesterase 10 (PDE10) inhibitor, BEN-8744, intended for the treatment of ulcerative colitis (UC). The topline data readout from this study is expected in the first quarter of 2024.
UC is a chronic disease that causes inflammation and ulceration of the inner lining of the colon and rectum. UC affects 0.4% of the US population, and 31% of patients have moderate-to-severe disease. Twenty to forty percent of those patients with moderate-to-severe UC do not respond to anti-TNF, the main treatment approach, whilst currently available treatments may come with severe side effects.
As well as first-in-class treatment for UC, BEN-8744, administered orally, also has the potential to address other indications within inflammatory bowel disease. BEN-8744 constitutes a different mechanism of action for the treatment of UC, providing an opportunity for further differentiation based on safety and efficacy.
Dr Anne Phelan, Chief Scientific Officer of BenevolentAI, said: “UC is a disease with significant unmet patient needs, as rates of sustained remission remain disappointingly low. Initiation of this Phase I study marks a significant milestone in treating this complex disease and serves as the leading asset in our clinical development portfolio. BEN-8744 exemplifies our innovative approach targeting a novel pathway with the potential for meaningful differentiation from existing standard-of-care treatments.”
Joanna Shields, Chief Executive Officer of BenevolentAI, said: “Our AI powered drug discovery platform identified PDE10 as a novel target for UC, with no prior direct associations linking it in scientific literature. BEN-8744 demonstrates the capacity of our technology platform to uncover novel avenues in the treatment of disease.”