BEN-8744 / BenevolentAI - LARVOL DELTA

Development of BEN8744, a phase 2 ready, peripherally restricted PDE10 inhibitor targeting a new mechanism of action for the treatment of ulcerative colitis. (ECCO-IBD 2025) - P1 | "The Phase 1 study showed a favourable safety, tolerability, and PK profile for BEN8744, supporting its further development. We are now planning a study in patients with moderate to severely active ulcerative colitis."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CXCL8 • IL6 • TNFA

Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744. (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: BenevolentAI Bio | Recruiting ➔ Completed

Trial completion

BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers (Businesswire) - P1 | N=108 | NCT06118385 | "BenevolentAI...announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers....The Phase Ia study met its primary objective. BEN-8744 was safe and well tolerated, with no Serious Adverse Events (SAEs) reported in any dose cohorts. Importantly, given the liabilities associated with PDE10 inhibitors previously in clinical development for other central nervous system (CNS) indications, there was no evidence of CNS-associated adverse events; The pharmacokinetic profile of BEN-8744 generated in the study suggested that twice daily dosing should achieve the desired PDE10 target coverage to elicit a potential therapeutic effect in subsequent clinical studies in UC patients."

P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Phase I Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744. (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: BenevolentAI Bio

New P1 trial

BenevolentAI Doses First Participants in Clinical Trial of BEN-8744; Targets PDE10, an AI-derived Novel Target for the Treatment of Ulcerative Colitis (Businesswire) - "BenevolentAI...today announces 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 Q1 2024."

P1 data • Trial status • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

BenevolentAI Unaudited Preliminary Results for the Year Ended 31 December 2022 (Businesswire) - "BEN-2293...A topical potentially best-in-class PanTrk inhibitor in development to relieve inflammation and rapidly resolve the itch in patients with atopic dermatitis (AD). Completed a Phase IIa study and expect top-line data by the end of March 2023. BEN-8744...An oral peripherally-restricted small molecule PDE10 inhibitor under development as a first-in-class treatment for ulcerative colitis (UC) and with potential for other indications within inflammatory bowel diseases....expect to initiate a Phase I clinical trial in H1 2023. BEN-28010...An orally administered asset under development as a best-in-class treatment for glioblastoma multiforme (GBM). Declared as a clinical candidate in July 2022, with preparation for IND-enabling studies ongoing. The asset could be ready for Phase I studies in 2024."

New P1 trial • P2a data • Atopic Dermatitis • Glioblastoma • Glioma • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Solid Tumor • Ulcerative Colitis

BenevolentAI submits CTA for BEN-8744, an oral PDE10 inhibitor, as a first-in-class treatment for ulcerative colitis (Businesswire) - "BenevolentAI ​​(Euronext Amsterdam: BAI...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."

New P1 trial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

BenevolentAI Begins Trading On Euronext Amsterdam (Yahoo Finance) - "BenevolentAI (Euronext Amsterdam: BAI)...announces that trading in its shares is expected to begin today, following completion of the business combination of BenevolentAI Limited with Odyssey Acquisition S.A. ('Odyssey') on 22 April 2022 (the 'Business Combination')....as well as to complete the Phase I trial for BEN-8744 (ulcerative colitis) in 2023 before commencing a Phase II trial."

Commercial • Trial completion date • Inflammatory Bowel Disease • Ulcerative Colitis