Clinical Trials

Sosei Heptares has announced that it has dosed the first patient in its phase 1 trial assessing a novel EP4 receptor agonist, HTL0033744 (HTL’744) for the treatment of inflammatory bowel disease (IBD).

According to the company’s press release, the candidate 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’.

It is intended that this candidate will address the unmet need of patients with IBD that do not achieve satisfactory disease control, as current standard-of-care treatments typically lead to remission rates of less than 25%.

Matt Barnes, president of Heptares Therapeutic and head of UK R&D, commented: “It’s great to see the progression of HTL’744, another of our wholly owned assets, into the clinic. EP4 agonists are a recognised and exciting class of drugs with a dual mechanism of action that can resolve inflammation and promote mucosal healing. We’ve utilised 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 benefiting from the currently available treatments.”

The trial is a first-in-human randomised, double-blind study, which will evaluate the safety, pharmacokinetics and effects on pharmacodynamic biomarkers of single and multiple ascending doses of the drug in health adult volunteers as well as patients with Crohn’s disease.