transplantation that inspired Seres Health’s efforts. It’s pretty much what it sounds like: feces from a healthy person is transferred to a sick one. The field received more clinical validation from a study published in early 2013 that showed fecal transplants worked much better than the standard antibiotic, vancomycin. And the FDA said last summer it would be flexible in allowing fecal transplant testing for the treatment of C. difficile. (SER-109 is aimed at patients whose infections are resistant to vancomycin treatment.)
SER-109’s potential fast track to the market could provide commercial validation for other microbiome startups, and those looking to start new ones. But success in C diff, a relatively simple problem, won’t easily translate to more complicated diseases.
“FMT [fecal transplantation] and the Seres data have taught me we’re closer to the clinic with directed enteric microbial therapies than I thought a few years ago,” says Janssen’s Plevy, a trained gastroenterologist who treated patients with FMT in his time at the University of North Carolina medical center. “But we have a long way to go” in other areas where the microbiome is implicated. For example, Pleavy says, studies of FMT in irritable bowel disease, once the treatment is compared to placebo, have had disappointing results.
Only a handful of venture-backed startups are pursuing microbiome-based therapies. Vedanta Biosciences is developing a mix of Clostridia bacterial strains (not the difficile kind) to treat inflammatory bowel disease. Second Genome also wants to tackle inflammatory and other diseases, but with small molecules that change the way the patient’s gut tissue interacts with the bacteria.
Both companies have gained the backing of Johnson & Johnson (NYSE: [[ticker:JNJ]]), which so far has been the most aggressive pharma collaborator in the microbiome area, at least publicly. Second Genome is also studying the microbiome’s role in obesity and metabolic disease with Pfizer (NYSE: [[ticker:PFE]]).
Seres has no corporate partnerships yet, but Pomerantz said he’d like to find a partner to help bring SER-109 to market outside the U.S., or perhaps in the U.S. as well if the right deal comes along.
In addition to bringing SER-109 to market for C. diff patients with no other treatment options, the firm would like to produce a first-line treatment for the infection: a population about five times as large. To do so, Seres will need a new production system. Instead of using human feces as a source of spores, Pomerantz said Seres wants to produce them synthetically. Those first-line infections, while very serious, aren’t as grevious a medical problem as the recurrent infections, so the product would likely have to clear a higher regulatory bar, as well.
