BEN-8744 demonstrates the potential of the Benevolent Platform™️ to discover new targets not previously associated with a particular disease
The start of Phase I of the clinical trial is planned for the first half of 2023
LONDON, December 21, 2022—(BUSINESS WIRE)–BenevolentAI (Euronext Amsterdam: BAI), a leading AI-powered clinical-stage drug discovery company, announces that it has submitted a Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) for BEN-8744, an oral phosphodiesterase 10 (PDE10) inhibitor in development for the treatment of ulcerative colitis (UC). Subject to obtaining MHRA CTA approval, BenevolentAI plans to initiate a Phase I clinical trial of BEN-8744, which is expected to begin in the first half of 2023.
Anne Phelan, Chief Scientific Officer at BenevolentAI, commented: “We are pleased to submit the CTA for BEN-8744 in line with our development timeline as we continue to advance this exciting investigational drug toward the clinic. We believe BEN-8744 has the potential to be a novel treatment for UC: a complex multifactorial disease that remains underserved by current standard-of-care therapies. BEN-8744 demonstrates BenevolentAI’s unique ability to use vast amounts of multimodal data to discover new targets not previously associated with a particular disease and increases confidence in the early stages of drug discovery. Following the rapid delivery of this drug candidate within just two years from targeted validation, we look forward to starting the first human studies next year.”
BEN-8744 is an orally administered peripherally restricted small molecule PDE10 inhibitor being developed as a first-in-class treatment for ulcerative colitis with potential for other indications within inflammatory bowel disease. BEN-8744 is distinguished by its novel mechanism of action; there is the possibility of further differentiating BEN-8744 based on safety and efficacy.
PDE10 reduces intracellular levels of the signaling molecule cGMP. Restoration of cGMP levels by PDE10 inhibition is hypothesized to have direct anti-inflammatory and disease-modifying benefits.
BenevolentAI will try to show that BEN-8744 is effective in treating moderate to severe cases of UC with fewer side effects than the anti-TNF and JAK inhibitors that are currently the dominant form of treatment for this disease.
BenevolentAI has filed for other medical use and composition of matter patents related to BEN-8744. BEN-8744 is a wholly owned product in the BenevolentAI drug program.
About ulcerative colitis
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 patients with moderate to severe UC do not respond to anti-TNF, the main treatment approach, and currently available treatments can have serious side effects.
BenevolentAI (AMS: BAI) is a leading clinical AI-enabled drug discovery and development company listed on Euronext Amsterdam. Through the combined capabilities of its AI platform, scientific expertise and wet labs, BenevolentAI is well positioned to deliver new drug candidates with a higher likelihood of clinical success than those developed through traditional methods. The Benevolent Platform™ powers a growing internal pipeline of 13 named drug programs and over 10 research programs, and maintains successful collaborations with AstraZeneca as well as leading research and philanthropic institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.
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Rajin Kang – Vice President of Communications
Ben Atwell, Simon Conway, Victoria Foster Mitchell
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