[Corrected 7/17/14, 10:46am. See below.] The first regulated therapy to emerge from the recent explosion of microbiome research is one step closer. And the company developing it, Seres Health, is stepping toward the first microbiome startup IPO, Xconomy has learned.
The Cambridge, MA startup announced today that its lead product, made from a mix of bacterial spores, has effectively cured 29 of 30 patients who suffered from recurring infection of the potentially deadly bacterium Clostridium difficile, or C. diff.
Seres already told us in January that 9 of the first 10 patients had no recurring infection.
But what makes the update newsworthy, other than the growing body of clinical data, is that Seres is now planning a much larger trial by the end of the year. It will also apply to the Food and Drug Administration for special “breakthrough” status that would help speed up development and regulatory timelines for the product.
If those plans hold steady, a regulated microbiome therapeutic could be available sooner than anyone might have expected a couple years ago.
“It’s fair to say that Seres is furthest along in trying to find defined microbial consortia to treat C. diff,” says Scott Plevy, a vice president at Janssen Research and Development who leads the inflammatory bowel disease group. Janssen, part of Johnson & Johnson, has been active in microbiome research and collaborations, but is not a partner of Seres Health.
The “drug” is remarkable itself: it uses the spores of bacteria, like the seeds of a plant, that can survive all kinds of inhospitable conditions, both inside and outside the body. Seres has identified 50 bacteria—that’s the “consortia” Plevy refers to—that help re-balance the microbial mix in a C. difficile-infected gut, and the spores of those bacteria, isolated from healthy human feces, are put into a pill. When they enter the gut, they grow into bacteria. [A previous version of this story misspelled Scott Plevy’s last name. We apologize for the error.]
Seres CEO Roger Pomerantz (pictured above) tells Xconomy that the company wants to start a trial in December that could be “pivotal”—industry-speak for the final step before asking the FDA for marketing approval. The company is negotiating that possibility with the FDA now, he says.
Pomerantz, an infectious disease specialist and former top dealmaker at Merck & Co., also says he’s working to take Seres public after only two rounds of venture funding totaling $20 million. He’s been chairman since November and was recently named CEO.
The IPO revelation for Seres comes just as public biotech markets have cooled off. A U.S. Federal Reserve report Tuesday said valuations for small companies in social media and biotechnology “appear substantially stretched.” The report accompanied Fed chairwoman Janet Yellen’s regular testimony before Congress, and the two major U.S. biotech indices have since dropped about 3.5 percent each.
Seres began as a project within the VentureLabs group at Flagship Ventures of Cambridge. Flagship supplied the first $10 million, then led a $10 million Series B round that included Enso Ventures, the Mayo Clinic, Alexandria Real Estate, and undisclosed private backers.
Every day, it seems, more is discovered about the links between our health and the state and composition of our microbes, without which we wouldn’t exist. But so far, relatively few targets have been explored enough to give drug developers confidence to invest in programs to alter the microbiome and make us healthier.
C. difficile is one of those targets. The bacteria often takes over when the normal, healthy mix of gut microbes has been blasted away by antibiotics and the immune system has been weakened, typically in patients already in hospitals and other health facilities. The terrible diarrhea that results kills 14,000 people in the U.S. alone each year, according to the Centers for Disease Control and Prevention.
Outside the FDA’s purview, doctors for decades have been using a treatment called fecal microbial 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: 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: 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.
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