Sosei Heptares Doses First Subject in Phase 1 Trial with HTL0033744, an EP4 Agonist for Inflammatory Bowel Disease

• HTL0033744 has been designed by Sosei Heptares to promote mucosal healing and resolve inflammation in people with IBD

Tokyo, Japan and Cambridge, UK, 21 March 2024 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) announces it has dosed the first subject in a Phase 1 trial evaluating its novel EP4 receptor agonist, HTL0033744 (HTL’744) for the treatment of Inflammatory Bowel Disease (IBD), a therapeutic area where there remains significant unmet need for millions of people worldwide.

HTL’744 is a potent, selective and gut-restricted prostaglandin EP4 receptor agonist that has been uniquely designed to bring clinical benefit by accelerating the healing of damaged epithelial mucosa and suppressing exaggerated gut inflammation, with minimal systemic exposure to avoid adverse events. This approach is widely recognized to promote deeper remission and offer better long-term clinical outcomes^1,2.

HTL’744 aims to address the significant unmet need of people with IBD that do not achieve satisfactory disease control. Current treatments for IBD typically achieve remission rates of less than 25%, and the safety profile of these drugs mean that they require careful monitoring.

The Phase 1 trial is a first-in-human randomized, double-blind study to assess the safety, pharmacokinetics and effects on pharmacodynamic biomarkers of single and multiple ascending doses of HTL’744 in adult healthy volunteers and people with Crohn’s disease to generate proof of mechanism. The trial will be conducted in the UK and initial data read-outs are anticipated from 2025.

Matt Barnes, President of Heptares Therapeutics and Head of UK R&D, said: “It’s great to see the progression of HTL’744, another of our wholly owned assets, into the clinic. EP4 agonists are a recognized and exciting class of drugs with a dual mechanism of action that can resolve inflammation and promote mucosal healing. We’ve utilized our StaR/SBDD platform to develop a potent, selective and gut-restricted molecule that has potential to change the lives of the millions of people with IBD worldwide who are not benefitting from the currently available treatments.”

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About Sosei Heptares
Sosei Heptares is a fully integrated, technology enabled pharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global pharmaceutical champions.