Sosei Group Corporation announced 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.

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.