French pharmaceuticals and diagnostics company Enterome has initiated its Phase I clinical study of EB8018 to treat Crohn's disease.
Developed as non-biologic, non-steroidal, non-antibiotic, non-immunomodulatory and local approach for Crohn's disease, EB8018 is an orally administered, non-systemic, small molecule drug that blocks FimH adhesion.
Inhibition of FimH results in the prevention of local cytokine production and the entry of AIEC into the gut wall by specifically affecting the virulent bacteria, leaving the gut microbiome unharmed.
The Phase I clinical study will be conducted to test the safety and tolerability of single and multiple doses of EB8018 while treating healthy subjects.
It will also determine pharmacokinetic profile of single and multiple doses of EB8018 and its effect on the healthy gut microbiome.
Enterome CEO Pierre Belichard said: "We are delighted to have started the clinical development of our lead drug candidate EB8018.
“This represents an important milestone for Enterome and validation of our capability to identify novel targets derived from the microbiome that we can use to develop small molecule drug candidates originating either from our internal resources or via in-licensing, as is the case with EB8018.”
Enterome is expected to release the trial data this year and alongside the study, the company is also developing a non-invasive microbiome biomarker to identify the suitability of patients for treatment with EB8018.
Image: CT scan displaying Crohn's disease. Photo: courtesy of Samir.