BenevolentAI submits CTA for BEN-8744, an oral PDE10 inhibitor, as a first-in-class treatment for ulcerative colitis

  • BEN-8744 demonstrates the potential of the Benevolent Platform™️ to uncover novel targets not previously linked to a given disease
  • Initiation of Phase I clinical trial is planned for H1 2023

London, 21 December, 2022: BenevolentAI ​​(Euronext Amsterdam: BAI), a leading clinical-stage AI-enabled drug discovery company, announces it has submitted a Clinical Trial Application (CTA) to the UK 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 approval on the CTA, BenevolentAI plans to initiate a Phase I clinical trial of BEN-8744, anticipated to commence in the first half of 2023.

Anne Phelan, Chief Scientific Officer at BenevolentAI, commented: “We are pleased to submit a CTA for BEN-8744 in line with our development timeline as we continue to progress this exciting investigational drug towards 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 the Benevolent Platform™'s unique ability to use vast quantities of multimodal data to uncover novel targets not previously linked to a given disease and increase confidence in the early phases of drug discovery. After rapidly delivering this drug candidate within just two years of target validation, we look forward to commencing first-in-human studies next year.”

About BEN-8744
BEN-8744 is an orally administered, peripherally restricted small molecule PDE10 inhibitor under development as a first-in-class treatment for ulcerative colitis and with the potential for other indications within inflammatory bowel disease. BEN-8744 is differentiated by its novel mechanism of action; there is an opportunity to further differentiate BEN-8744 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. 

BenevolentAI will look to demonstrate that BEN-8744 is effective in treating moderate-to-severe cases of UC and 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 second medical use and composition of matter patents in respect of BEN-8744. BEN-8744 is a wholly owned asset in the BenevolentAI drug programme pipeline.

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 those patients with moderate-to-severe UC do not respond to anti-TNF, the main treatment approach, and currently available treatments can have severe 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. Through the combined capabilities of its AI platform, scientific expertise, and wet-lab facilities, BenevolentAI is well-positioned to deliver novel drug candidates with a higher probability of clinical success than those developed using traditional methods. The Benevolent Platform™ powers a growing in-house pipeline of 13 named drug programmes and over 10 exploratory programmes, and it maintains successful collaborations with AstraZeneca, as well as leading research and charitable institutions. BenevolentAI is headquartered in London, with a research facility in Cambridge (UK) and a further 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 may be identified by words such as "plans", "targets", "aims", "believes", "expects", "anticipates", "intends", "estimates", "will", "may", "should" and similar expressions. Forward-looking statements include statements regarding objectives, goals, strategies, outlook and growth prospects; future plans, events or performance and potential for future growth; economic outlook and industry trends; developments in BenevolentAI’s markets; the impact of regulatory initiatives; and/or the strength of BenevolentAI’s competitors. These forward-looking statements reflect, at the time made, BenevolentAI’s beliefs, intentions and current targets/aims. 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 upon various assumptions based on, without limitation, management's examination of historical operating trends, data contained in BenevolentAI’s records, and third-party data. Although BenevolentAI believes these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which 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 the actual outcomes and the results of operations, financial condition and liquidity of BenevolentAI or the industry to differ materially from those results expressed or implied by such forward-looking statements. The forward-looking statements speak only as of the date of this release. No representation or warranty is made that any of these forward-looking statements or forecasts will come to pass or that any forecast result will be achieved.


Rajin Kang - VP Communications 


Fleur Wood – VP Investor Relations 

FTI Consulting:

Ben Atwell, Simon Conway, Victoria Foster Mitchell 

+44 (0) 20 3727 1000

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