close

Clinical Trials

Date: 2017-10-27

Type of information: Completion of the trial

phase: 1

Announcement: completion of the trial

Company: Enterome Bioscience (France)

Product: EB8018

Action mechanism:

  • FimH antagonist.  Enterome has identified the FimH adhesin from overabundant E. coli species as a potential novel target to block inflammation in Crohn’s disease through application of its metagenomics platform to the microbiomes of patients suffering from Crohn’s disease. Independent studies have also demonstrated an imbalance of the microbiomes of such patients with a significant increase of E. coli with invasive properties, termed adherent-invasive E. coli (AIEC). These AIEC bacteria attach to the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently trigger inflammation by inducing local production of cytokines and invasion of the gut wall through activation of TLR4 and CEACAM6 receptors which are strongly upregulated in the ileum of Crohn’s disease patients. In April 2016, Enterome has signed an exclusive worldwide license agreement with Vertex Pharmaceuticals to research, develop and commercialize novel small molecule FimH antagonists, including EB 8018. This compound represents a novel, non-biologic, non-steroidal, non-antibiotic, non-immunomodulatory and local approach for the treatment of Crohn’s disease.

Disease: Crohn's disease

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Country: UK

Trial details:

  • 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. (NCT02998190)

Latest news:

  • • On October 27, 2017, Enterome  announce 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 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.
  • • On January 5, 2017, Enterome announced the launch of a Phase 1 clinical study with its lead small molecule drug candidate EB8018, a small molecule designed to block FimH, as a potential new treatment for Crohn’s disease. The phase 1 clinical study is designed to determine the safety and tolerability profile of single and multiple doses of EB8018 in healthy subjects. The study will also assess 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 non-invasive microbiome biomarker to identify patients that may benefit from treatment with EB8018. Enterome looks forward to reporting the results from the phase 1 study later in 2017

Is general: Yes