Takeda Signs $50M Deal with Enterome for Crohn’s Disease Treatment

Enterome, a clinical-stage French biotech with its U.S. headquarters in Cambridge, has entered into a global licensing, co-development and co-promotion agreement with Takeda Pharmaceutical. Enterome is developing innovative therapies to treat microbiome-associated diseases with a focus on auto-immune disease and cancer. The agreement covers Enterome’s lead investigational drug candidate EB8018 in patients with Crohn’s disease, with the potential to expand to other gastrointestinal (GI) disorders and liver diseases.

EB8018 is a novel, first-in-class, orally administered, gut-restricted small molecule designed to selectively disarm virulent bacteria in the gut that can cause inflammation without disrupting the local microbiome. EB8018 was originally discovered by Vertex Pharmaceuticals, Inc.

EB8018 successfully completed a Phase 1a trial, where the study results demonstrated that administration of EB8018 in the dose range examined was safe and exhibited minimal blood absorption. A Phase 1b study to evaluate safety, tolerability, pharmacokinetic profile and preliminary efficacy signals of EB8018 when given to patient volunteers with active Crohn’s disease is underway.

Enterome will receive an upfront payment of $50 million and a commitment from Takeda to make a future equity investment in the Company. Enterome is also eligible to receive up to $640 million for achieving specified clinical development, regulatory and commercial milestones with EB8018. In addition, Enterome and Takeda will co-develop EB8018 under the joint agreement and, if approved, the product will be co-promoted in the US under a profit/cost sharing structure. Takeda will receive an exclusive license to commercialize EB8018 outside of the US, and Enterome will be eligible to receive royalties on net sales generated in these territories.

The global agreement is the second collaboration between Enterome and Takeda. In 2016, the two companies entered a strategic drug discovery collaboration focused on microbiome targets across multiple GI disorders, including inflammatory bowel disease and motility disorders. (Source: Enterome website, 23 October, 2018)