Enterome SA, a pioneer of innovative therapies for microbiome-related diseases, has announced the successful completion of the first phase 1 clinical study with its lead candidate EB8018, a small molecule designed to block FimH, as a potential new orally-administered treatment for Crohn’s disease.
EB8018 was found to be well tolerated in healthy volunteers across a wide range of doses tested. The compound also demonstrated a pharmacokinetic (PK) profile consistent with it being a gut-restricted molecule that is soluble in the gut and thereby able to act on its target in the gut microbiome. EB8018 also exhibited minimal absorption into the blood potentially limiting interactions with other drugs that are absorbed into the blood stream. The results from the study will be presented at an upcoming medical congress.
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.”