BenevolentAI announced that the first participants have been dosed 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 First Quarter 2024. BEN-8744 is a peripherally restricted small molecule PDE10 inhibitor in development as a potential first-in-class treatment for Ulcerative Colitis (UC).

Administered orally, it also has the potential for addressing 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. PDE10 reduces intracellular levels of the signalling molecule cGMP.

Restoration of cGMP levels by PDE10 inhibition is anticipated to have a direct anti-inflammatory and disease-modifying benefit. BEN-8744 is a wholly owned asset in the BenevolentAI drug programme pipeline. 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. 20-40% 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.