Enterome is in the process of initiating a phase 1b trial of EB8018 in patients with Crohn’s Disease who have active inflammation of the gut. This study will investigate the safety, PK and preliminary signals of efficacy of EB8018. The results from these studies are expected to provide information that will support the design of a Phase 2 clinical proof-of-concept trial with EB8018 that is planned to start in 2018.
The Phase 1 study was designed to determine the safety and tolerability profile of single and multiple doses of EB8018 in healthy subjects. The study also assessed the pharmacokinetic profile of single and multiple doses of EB8018 and the effects of EB8018 on the healthy gut microbiome. In parallel with the Phase 1 study, Enterome is developing a potential non-invasive microbiome biomarker to identify patients that may benefit from treatment with EB8018.
Jai Patel, Enterome’s chief medical officer, said: “The outcome of the first-in-human trial with EB8018 is an encouraging step towards demonstrating its clinical potential in patients with active Crohn’s Disease. EB8018 is a first-in-class, orally-administered investigational medicine that is targeted at disarming specific bacteria in the gut that cause inflammation, without disrupting the microbiome. It represents a novel, non-biologic, non-steroidal, non-immunomodulatory approach for the treatment of Crohn’s Disease. We are now preparing to test EB8018 in Crohn’s patients with a view to a larger scale clinical proof-of-concept trial next year.”
Enterome completes, treat crohn’s disease