BenevolentAI Submits CTA for BEN-8744, Oral PDE10 Inhibitor, as First-in-Class Treatment for Ulcerative Colitis

  • 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.”

About BEN-8744

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.

About BenevolentAI

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.

Forward-looking statements

This press release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and can be identified by words such as “plans,” “goals,” “targets,” “believes,” “expects,” “anticipates,” “intends,” “estimates “, “will”, “can”, “should” and similar expressions. Forward-looking statements include statements regarding goals, strategies, prospects and growth prospects; future plans, events or performance and potential for future growth; economic outlook and industry trends; developments in BenevolentAI’s markets; impact of regulatory initiatives; and/or the strength of BenevolentAI’s competitors. These forward-looking statements reflect, at the time, the beliefs, intentions and current goals/objectives of BenevolentAI. Forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements in this release are based on various assumptions based on, without limitation, management’s examination of historical operating trends, information contained in BenevolentAI’s records and information from third parties. Although BenevolentAI believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors that are difficult or impossible to predict and are beyond BenevolentAI’s control. Forward-looking statements are not guarantees of future performance, and such risks, uncertainties, contingencies and other important factors could cause actual outcomes and results of operations, financial condition and liquidity of BenevolentAI or the industry to differ materially from those results expressed or implied. such forward-looking statements. Forward-looking statements speak only as of the date of this release. There is no representation or warranty that any of these statements or predictions will materialize or that any anticipated result will be achieved.

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Rajin Kang – Vice President of Communications
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Fleur Wood – Vice President of Investor Relations
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FTI consulting:
Ben Atwell, Simon Conway, Victoria Foster Mitchell
[email protected]
+44 (0) 20 3727 1000

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