Cooperating on Crohn's disease

PARIS & CAMBRIDGE, Mass.—As October comes to an end, a new agreement is getting off the ground between Enterome SA and Takeda Pharmaceutical Co. Ltd. The companies have inked a global licensing, co-development and co-promotion agreement centered on EB8018, Enterome's lead investigational drug candidate. The agreement is focused on EB8018 in the indication of Crohn's disease, but it could be expanded to include additional gastrointestinal disorders and liver diseases.

Per the terms of the agreement, Takeda will pay Enterome $50 million up front, with a commitment to make a future equity investment as well. Enterome stands to receive up to $640 million in milestone payments if certain clinical development, regulatory and commercial milestones are met. The partners will co-develop EB8018 under this joint agreement, and should it gain regulatory approval, they will co-promote the drug under a profit/cost-sharing structure. Takeda will hold an exclusive license to commercialize EB8018 outside of the United States, with Enterome standing to receive royalties on net sales generated in those non-U.S. territories.

“We are delighted to sign this agreement for EB8018, our most advanced candidate that represents a non-antibiotic, non-steroidal, non-immunomodulatory approach for the treatment of GI disorders including Crohn’s disease,” Pierre Belichard, CEO of Enterome, said in a press release. “We believe we have a world-class partner in Takeda to deliver the best development and commercialization strategy for EB8018 based on their extensive expertise and focus in Crohn’s disease and GI disorders. We are very excited about the potential of EB8018 and look forward to deepening our relationship with Takeda as we advance this novel candidate through clinical development.”

Enterome's EB8018 is a novel, first-in-class, orally administered, gut-restricted small molecule. It selectively disarms virulent gut bacteria tied to inflammation, but importantly, does so without unbalancing the gut microbiome. By inhibiting FimH-mediated inflammation, which results when pathogenic pro-inflammatory bacteria interact with receptors in the gut wall, it can help to reduce the influx of inflammatory cytokines. EB8018 has completed a Phase 1a trial, in which its dose range was found to be safe with minimal blood absorption. The compound is now undergoing evaluation in a Phase 1b study focused on safety, tolerability, pharmacokinetic profile and preliminary efficacy in patients with active Crohn's disease.

“At Takeda, we are continually exploring diverse modalities with the hope to deliver medicines that break the loop of unpredictable disruption that people living with GI disorders experience every day,” commented Dr. Asit Parikh, head of the Gastroenterology Therapeutic Area Unit at Takeda. “We are excited to partner again with Enterome on such a novel approach and work together to advance EB8018 through clinical development.”

The aforementioned first instance of partnering between Takeda and Enterome occurred two years ago. In January 2016, the companies struck up a strategic drug discovery collaboration focused on researching and developing new therapeutics against microbiome targets implicated in GI disorders such as ulcerative colitis and irritable bowel syndrome.

The agreement stated that Enterome would apply its proprietary metagenomic platform to discover small molecules or biologics derived from gut bacteria. Though specific financial details were not released, the agreement called for Enterome to receive an upfront payment, R&D funding for three years and potentially milestone payments tied to option exercise, development, regulatory and commercial milestones for each molecule discovered under the agreement. Enterome also stands to receive tiered royalties on net sales of any products Takeda elects to commercialize. Takeda holds an option to license select agents on an exclusive global basis under the deal, and in turn will assume responsibility for the regulatory and clinical development and commercialization of said agents.