Microbiome therapeutics: Enterome seals €600m licensing and co-development deal with Takeda

By Nathan Gray

- Last updated on GMT

iStock / Artsanova
iStock / Artsanova
French microbiome biotechnology firm Enterome has signed a global licensing, co-development and co-promotion agreement with major pharmaceutical player Takeda.

The deal 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.

Takeda has paid €43.6 million ($50 million USD) upfront to co-develop the early-phase Crohn’s disease candidate EB8018 – with a commitment from Takeda to make a future equity investment in the Enterome.

The French clinical-stage biotech is also eligible to receive up to €558 million ($640m USD) in milestone payments for achieving specified clinical development, regulatory and commercial targets with EB8018.

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.

"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,"​ commented Pierre Belichard, CEO of Enterome.

Nutra notes: Microbiome partnerships

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.

Enterome's partners include Takeda, Bristol-Myers Squibb and Johnson & Johnson Innovation/Janssen Biotech.

The company is backed by leading venture capital investors including Seventure Partners, Lundbeckfonden Ventures, Health for Life Capital, Omnes Capital and Principia, in addition to a number of strategic investors including BMS, Nestlé Health Science, Shire and INRA Transfert.

What is EB8018?

EB8018 blocks the activity of FimH, an adhesion protein expressed by certain bacterial pathogens – including – including E. coli​. The EB8018 molecule is suggested to work by blocking FimH adhesion to the gut cell wall, so preventing the activation of inflammatory cascades that are involved in GI disorders including Crohn's disease.

FimH was validated as a novel microbiome-derived therapeutic target by Enterome through application of its proprietary metagenomics platform, while EB8018 was originally discovered by Vertex Pharmaceuticals, Inc.

EB8018 successfully completed a Phase 1a trial, with results showing that administration of the molecule 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 currently underway.

If the safety and PK data are comparable to the results of the earlier trial, Enterome and Takeda will move into a phase 2a.

"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,” ​said Belichard.

“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."

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