|Seres CEO Roger Pomerantz|
Cambridge, MA's Seres Therapeutics won the FDA's coveted breakthrough-therapy designation for its lead microbiome treatment, promising the company a speedy regulatory review as it prepares to go public.
Seres' lead asset is SER-109, a Tylenol-sized capsule designed to treat recurrent Clostridium difficile infections by essentially changing the weather in the gut. Inside each person is an ecosystem of more than 100 trillion microorganisms, making up what scientists have termed the microbiome, and Seres has crafted a treatment made up of spores that can alter the state of that ecosystem to combat disease.
With the FDA's breakthrough nod, Seres is guaranteed access to top agency officials as it pushes SER-109 through clinical development and is eligible for a truncated review process once the company submits its candidate. The pill is in the midst of a Phase II study slated to wrap up in the middle of next year, and Seres plans to kick off Phase III development thereafter.
Meanwhile, the Flagship Ventures-founded company is gearing up for a $100 million IPO, filing in May to hit the Nasdaq and raise cash for its pipeline of microbiome treatments. Seres plans to trade under the symbol "MCBM" and is yet to spell out how many shares it intends to offer or at what price.
Behind SER-109, the biotech is working a preclinical C. diff. treatment called SER-262 and a handful of early-stage candidates for inflammatory bowel diseases and bacterial infections.
Key to each of Seres' projects is its internal R&D engine, through which the company contrasts the gut compositions of healthy people with those suffering from a targeted disease. Using proprietary algorithms, Seres works to identify what in the former gut is missing from the latter, growing the necessary spores and packaging them in a pill.
Microbiomics is a fast-growing field in biotech, including Second Genome, Vedanta Biosciences and Enterome Biosciences.
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Special Report: FierceBiotech's 2014 Fierce 15 - Seres Health