BenevolentAI Introduces CTA for BEN-8744, an Oral PDE10 Inhibitor, as a First-Class Treatment for Ulcerative Colitis

  • BEN-8744 demonstrates the potential of the Benevolent Platform™️ to discover new targets not previously linked to a given disease

  • The phase I clinical trial is scheduled to start in the first half of 2023

LONDON, 21 December 2022–(BUSINESS WIRE)–BenevolentAI (Euronext Amsterdam: BAI), a leader in clinical-stage AI-enabled drug discovery, announces that it has submitted a clinical trial application (CTA) to the agency Medicines and Healthcare products Regulatory Authority (MHRA) for BEN-8744, an oral phosphodiesterase 10 (PDE10) inhibitor under development for the treatment of ulcerative colitis (UC). Subject to obtaining MHRA approval on the CTA, 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 of BenevolentAI, commented: “We are pleased to present a CTA for BEN-8744 in line with our development timeline as we continue to bring this exciting investigational drug to the clinic. We believe BEN-8744 has the potential to be a novel treatment for UC: a multifactorial complex disease that remains underserved by current standard-of-care therapies BEN-8744 demonstrates BenevolentAI’s unique ability to use large amounts of multimodal data to discover new targets not previously linked to a given disease and increase confidence in the early stages of drug discovery by delivering rapidly develop this drug candidate within just two years of target validation, we look forward to starting the first human trials next year.”

About BEN-8744

BEN-8744 is an orally administered peripherally restricted small molecule PDE10 inhibitor in development as a first-in-class treatment for ulcerative colitis and with the potential for other indications within inflammatory bowel disease. BEN-8744 differs in its new mechanism of action; there is an opportunity to further differentiate BEN-8744 based on safety and efficacy.

PDE10 reduces intracellular levels of the signaling molecule cGMP. Restoration of cGMP levels by PDE10 inhibition is expected to have a direct anti-inflammatory and disease-modifying benefit.

BenevolentAI will seek to demonstrate that BEN-8744 is effective in treating moderate to severe cases of UC and with fewer side effects than anti-TNF and JAK inhibitors which are currently the dominant form of treatment for this disease.

BenevolentAI has filed for a second patent for medical use and composition of matter related to BEN-8744. BEN-8744 is a wholly owned asset in the pipeline of the BenevolentAI anti-drug program.

About ulcerative colitis

Ulcerative colitis is a chronic disease that causes inflammation and ulceration of the inner lining of the colon and rectum. Ulcerative colitis 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 fail to respond to anti-TNF, the main therapeutic approach, and currently available treatments can have serious side effects.

About BenevolentAI

BenevolentAI (AMS: BAI) is a leading clinical-stage AI-enabled drug discovery and development company, listed on the Euronext Amsterdam stock exchange. Thanks to the combined capabilities of its AI platform, scientific expertise, and wet lab facilities, BenevolentAI is well positioned to deliver new drug candidates with a higher likelihood of clinical success than those developed using traditional methods. The Benevolent Platform™ powers a growing internal pipeline of 13 named drug programs and over 10 exploratory programs and maintains successful partnerships with AstraZeneca, as well as leading research and charities. BenevolentAI is based in London, with a research facility in Cambridge (UK) and an additional office in New York.

Forward-Looking Statements

This 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”, “objectives”, “objectives”, “believes”, “expects”, “anticipates”, “intends”, “estimates”, “will”, “may”, “should” and similar expressions. Forward-looking statements include statements regarding goals, objectives, strategies, prospects and growth prospects; future plans, events or performance and potential for future growth; economic outlook and industry trends; developments in the BenevolentAI markets; the impact of regulatory initiatives; and/or the strength of BenevolentAI’s competitors. These forward-looking statements reflect BenevolentAI’s current beliefs, intentions and goals at the time. 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. The forward-looking statements in this release are based on various assumptions based on, without limitation, management’s examination of historical operating trends, data contained in BenevolentAI’s records, and data from third parties. While BenevolentAI believes these assumptions were reasonable when made, such 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 results and results of operations, financial condition and liquidity of BenevolentAI or the industry to differ materially from such expressed results or implied by such forward-looking statements. Forward-looking statements speak only as of the date of this release. No representations or warranties are made that any of these forward-looking statements or predictions will materialize or that any anticipated results will be achieved.

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Rajin Kang – Vice President of Communications
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Fleur Wood – Vice President Investor Relations
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FTI Consulting:
Ben Atwell, Simon Conway, Victoria Foster Mitchell
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