When Roger Pomerantz, the CEO of Cambridge, MA-based Seres Health said last week that he’s preparing to take his company public off of a promising, early study, it wasn’t just the natural next step for a biotech startup. It also marked a key transition point for an entire field of scientific research. After a lot of hype, therapeutics targeting the human microbiome—a catch-all term for the trillions of little bacteria that populate our bodies—just might be finally becoming more than cool lab experiments.
Indeed, should Seres follow through by filing papers with the Securities and Exchange Commission, and pitching itself to public investors, it will become the first company with a microbiome treatment to do so. The company is already blazing new paths in this emerging field: it’s planning a large clinical study later this year that could serve as a pivotal study, the last required before FDA approval. It’s also planning to apply for a “breakthrough” designation from the FDA, which would speed up development and regulatory review of its product, SER-109.
“I think they’re going to have a lot of attention,” says Miguel Barbosa, the head of Janssen Research & Development’s immunology research and scientific partnering strategy, of Seres as it moves forward.
Barbosa and Janssen have good reason to be interested. Janssen is a division of the big New Brunswick, NJ, healthcare conglomerate Johnson & Johnson (NYSE: JNJ) which, while not involved with Seres, has perhaps been perhaps the most aggressive pharmaceutical investor in microbiome therapeutics. J&J’s VC arm has made early bets on Cambridge-based Vedanta BioSciences, which is developing a microbiome treatment for inflammatory bowel disease, and San Bruno, CA-based Second Genome, which is exploring the role of microbes in other autoimmune diseases like ulcerative colitis. (Pfizer, too, began collaborating with Second Genome in May.) Those investments, and other academic collaborations with the Icahn School of Medicine at Mount Sinai and a few others, are all part of a broader effort by J&J to find clues to biological triggers underlying IBD.
Still, the field of microbiome therapeutics faces skepticism and logistical hurdles. And J&J is actually one of the few large pharmaceutical companies to put real dollars behind the research. The reason is that microbiome drugs represent a whole new class of potential medicines, so there are a number of unanswered questions: Will such drugs actually work? Can researchers gauge the effectiveness with biomarkers in clinical trials? Can products that essentially are live microorganisms culled from stool samples and packed into a pill be manufactured at scale? And can those bacteria be protected with intellectual property?
Even with the supposed potential of microbiome therapies, only a handful of startups are pursuing therapies: aside from Seres, Vedanta, and Second Genome, there’s Broomfield, CO-based MicroBiome Therapeutics, Paris-based Enterome Biosciences, which is developing a microbiome diagnostic, and Chapel Hill, NC-based Symberix. (Recently-launched Synlogic borrows from both synthetic biology and microbiome research.) Only Seres and MicroBiome have completed a Phase 1 study as of yet. In Seres’ study, its drug candidate SER-109, a pill made from a mix of bacterial spores, was reported to effectively cure 29 of 30 patients suffering from recurring infection of the potentially deadly bacterium Clostridium difficile, or C. diff.
All of which explains why Barbosa and others are keeping a close eye on Seres. Its progress, or lack thereof, both scientifically and in attracting investors or partners, may set the tone for the promise, and future investment dollars, that flow into the field. With microbiome drug development at a key crossroads, I spoke with Barbosa about potential—and the challenges—of developing and commercializing microbiome therapy, and what it’ll likely take to get these drugs to the finish line, among other things. Here are edited excerpts from our conversation:
Xconomy: Microbiome research hasn’t really been adopted across Big Pharma as of yet. Why is Janssen pushing hard, and what is it looking for?
Miguel Barbosa: This is a rapidly emerging and expanding field of research. Our interest here is twofold: one has to do with insights into how [IBD] is triggered—we’re very interested in looking at what components of the microbiome may be playing a key role. It’s also suggested in studies, both in the respiratory field as well as the gastrointestinal field, that … Next Page »