French Biotech’s Crohn’s Candidate Glides Through Phase I

Enterome has completed a Phase I study testing its leading Crohn’s disease candidate, which could become one of the first microbiome therapies on the market.

French biotech, Enterome, has developed an oral, microbiome therapy to combat Crohn’s disease. Many researchers are turning to the microbiome, as they believe the field could hold the key to human health. The candidate, EB8018 has demonstrated good tolerability at a range of doses and that it remains in the gut during a Phase I study. The company is now in the process of initiating a Phase Ib trial to investigate the drug’s safety, pharmacokinetics and efficacy that would support a Phase II study planned for next year.

Crohn’s disease is a chronic inflammatory condition affecting the gastrointestinal tract, which affects around 700,000 people in the US. Evidence suggests that an imbalance of bacteria in the microbiome could play an important role in stimulating the abnormal immune response that characterises the condition.


EB8018 takes care of this by attacking and disarming virulent bacteria, without disrupting the microbiome. In particular, it targets bacteria that express the FimH adhesin, which induces inflammation when it binds to the gut wall. By blocking FimH, inflammation in the gut is reduced as the bacteria no longer induce the production of cytokines that stimulate an immune response. The fact that EB8018 targets dangerous bacteria while leaving ‘good’ bacteria untouched makes it a much better option than antibiotics.

The microbiome is crucial to our health, so when ‘bad’ bacteria break in and disrupt it, we experience nasty effects.

This is a good response from Enterome to the news that its competitor, TiGenix, received an orphan drug designation from the FDA for its candidate to treat complex perianal fistulas – a nasty complication of Crohn’s disease. In addition, Enterome has its own diagnostics spin-off, Microbiome Diagnostics Partners (MDP) – currently focused on finding biomarkers for NASH – which will complement its pipeline nicely.

The field is full of diverse approaches to treating the condition, including Boehringer Ingelheim’s adalimumab biosimilar, Cyltezo, and TxCell’s T cell therapy – possibly trying to take advantage of a market that is expected to be worth up to $4.2B (€3.6B) by 2022. From what I can see, Enterome is the only company in the clinic using the microbiome to fight Crohn’s, so it currently leads the pack in this particular field.

The realization that not all bacteria are harmful and that the microbiome is a powerful tool for researchers has opened up another avenue for fighting disease – let’s hope we see some more exciting products in the clinic soon!

Images – Kateryna Kon /; Anatomy Insider /

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