Changes to the human gut microbiota are linked to serious diseases such as ulcerative colitis and Crohn's disease. While evidence has implicated disruptions to the homeostasis of the gut microbiome as playing a role in inflammatory bowel diseases, treatments aimed at reshaping the microbial content have failed to induce stable, long-term improvements in bacterial diversity.

Enterome SA hopes to change that prognosis, starting with the development of biomarkers for gut microbiota-related diseases – disorders resulting from abnormal bacterial composition in the human intestine.

The Paris-based company was launched in July 2011 with seed financing of €1.5 million (US$2.0 million) from the French venture capital firm Seventure Partners and INRA Transfert, which manages the technology portfolio of the Institut National de la Recherche Agronomique, where Enterome's metagenomic platform was originally developed by Dusko Ehrlich, the company's scientific founder.

Enterome has a collaboration agreement with INRA, of Jouy-en-Josas, France, providing the company with exclusive access to discoveries made using the platform in selected human pathologies, including Type II diabetes, liver and bowel diseases.

The human intestine harbors an incredible number of bacteria – the gut microbiota – encoding 150-fold more genes than the human genome, explained Pierre Belichard, Enterome's CEO. Each individual has his or her own unique microbiota, with a large diversity occurring in any given population.

Over the last five years, physicians and researchers have proven the role of gut microbiota in the development of various diseases, especially metabolic disorders and inflammatory bowel diseases, which, together, affect one-fourth of the population in the developed world, according to Belichard. Non-alcoholic steatohepatitis, or NASH, the most dangerous form, is present in 2 percent to 3 percent of the global population.

"Measurement and modulation of the gut microbiota's role in health and disease present the opportunity to impact medicine in an entirely new and unexplored way," he said.

Initially, Enterome is focusing on validating its proprietary biomarkers, translating them into diagnostics and commercializing them as laboratory-developed test services in the U.S. and Europe.

Eventually, the company plans to seek partnerships with pharmaceutical companies to strengthen its drug development capabilities.

In March, Enterome attracted €5 million in a Series A round, with Seventure and Copenhagen's Lundbeckfond Ventures as co-lead investors. The financing gives Enterome – which derived its name by combining the "enterotypes" of the human gut with the importance of the human "genome" – sufficient cash through mid-2013, according to Belichard.

How much funding the company will seek in a Series B next year depends on whether Enterome confines its work to biomarkers for the time being or in-licenses a compound to match its lead program in non-alcoholic fatty liver disease (NAFLD). About 20 percent of patients with the condition, which is the liver's part of metabolic syndrome, develop NASH, a chronic inflammation of the liver that can lead to cirrhosis and liver cancer.

The pharma industry's growing interest in using biomarkers as companion diagnostics and as tools to stratify patients and to select and measure drug development endpoints also presents an opportunity for Enterome to leverage its technology, Belichard said.

Today's biomarkers are developed just like drugs, over a two- to four-year time frame at a cost of $20 million to $50 million, he pointed out. Provided they succeed and pass regulatory muster, biomarkers may then attract interest from a variety of pharmas, diagnostics firms and pharmacy benefit managers.

Enterome's mission is to develop biomarkers that can be used to stratify patients according to their bacterial gut composition and associated risk to develop a given disease – initially, metabolic diseases – to monitor diseases of the gut as they evolve and, eventually, to develop drugs with enhanced efficiency.

"We are using the power of the metagenomics of the bacteria in the gut as a tool to discriminate between patients with disease and healthy patients, and this has been demonstrated in a number of papers," Belichard told BioWorld Today.

Enterome's six-member management team includes scientists specializing in biomarker development and former founders and executives of ophthalmology drug developer Fovea Pharmaceuticals SA, acquired in 2009 by Sanofi Aventis Group, of Paris, in a $538 million deal. (See BioWorld Today, Oct. 2, 2009.)

Belichard was Fovea's co-founder and chief operating officer. Bernard Gilly, Enterome's chairman, was Fovea's co-founder and CEO.

Enterome's fast-track model is similar to that of Fovea, which generated and moved three compounds into the clinic in as many years, raising $69 million along the way in two financing rounds.

Enterome plans to have its first stratification biomarker for NAFLD on the market in 2014 – which will generate cash for additional development – followed by a test to predict NAFLD's evolution toward NASH as early as 2015.

The last step in developing its franchise would be in-licensing or partnering to develop a compound to prevent NASH. That decision will come at the end of this year.

"At that time, we'll have a lot of data on our NASH biomarker," Belichard said, noting that the company is already examining a portfolio of drugs and talking with potential pharma partners.

In addition to NAFLD and inflammatory bowel disease, Enterome's metagenomic platform offers potential applications in asthma, autoimmune diseases and central nervous system diseases, which could add value to a potential suitor, he added.