Enterome Bioscience’s EB8018, a potential new therapy for Crohn’s disease, was well-tolerated by healthy volunteers in a Phase 1 clinical trial.
EB8018 targets the gut microbiome (the gut includes the alimentary tract, stomach and intestines), which is now a focus of much research because the bacteria in the gut can affect the immune system, and potentially influence the course of many diseases, even those affecting organs outside the gut. Enterome’s EB8018 is intended to fight inflammation-causing bacteria that live in the intestines along with types of beneficial bacteria, collectively called the gut microbiome.
The Phase 1 clinical trial (NCT02998190) included healthy men only. It was designed to evaluate the safety of EB8018, its presence in the bloodstream of those treated, and to assess the effects of the treatment on the bacteria living in the in the human gut.
The results of the trial showed that EB8018 is safe. Furthermore, not much of the drug was found in the bloodstream of treated volunteers, appearing to remain largely in the gut. This would prevent it from interacting with other drugs a patient might be taking at the same time.
The results will be presented at an upcoming medical congress.
EB8018 is administered orally. It targets a protein present on the surface of bacteria that is abundant in patients with Crohn’s, called FimH adhesin. EB8018 has been shown to reduce or eliminate inflammation in the walls lining the gut caused by the microbiome. It is a new approach for treating Crohn’s that is not based on biologics, steroids, or drugs that modulate the immune system.
Enterome is planning a Phase 1b clinical trial of EB8018 in patients with Crohn’s disease. It is anticipated that the Phase 1 and 1b studies will support a Phase 2 trial to start in 2018. In parallel to these studies, Enterome is attempting to develop biomarkers, molecules produced in the body, in order to identify the patients whose Crohn’s is likely to respond to EB8018.
The company also is a leader in developing industry standards for the analysis of microbiomes, potentially opening up new fields of drug discovery related to them.
“The outcome of the first-in-human trial with EB8018 is an encouraging step toward demonstrating its clinical potential in patients with active Crohn’s Disease. … 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,” Jai Patel, Enterome’s chief medical ffficer, said in a press release.
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