If you’re an investor anticipating the potential $100 million-plus IPO of microbiome company Seres Therapeutics, your wait should be over before the weekend comes. If you’re a patient with a terrible bacterial infection in your gut anticipating Seres’ lead product, you’ll probably have to wait at least a couple more years.
But that doesn’t mean you have to wait for a treatment. OpenBiome of Medford, MA, is already treating about 150 people a week for antibiotic-resistant Clostridium difficile infection, a nasty bug that is raising red flags around the world and kills as many as 29,000 people every year in the U.S. alone.
But OpenBiome is no hard-charging, venture-backed startup. It’s a nonprofit stool bank, a repository of public poop that its officials—although there’s little “official” in the demeanor of the young researchers and doctors from the U.S., Canada, and the U.K. who run it—say has two missions: to bring low-cost treatment to C. difficile patients who desperately need it, and to contribute to the fast-growing body of research on the human microbiome.
The microbiome, for those unfamiliar, is the collection of trillions of bacteria and other microbes on and in every human body. Its role in human health is a subject of intense research, and early returns already show a tight connection to a healthy gastrointestinal microbiome population and the ability to ward off things like C. diff, which takes over—sometimes with deadly effects—when the host’s regular microbial balance is thrown off by too many antibiotics, chemotherapy, or other disruption.
Startups such as Second Genome of South San Francisco, CA, and Vedanta Biosciences of Boston, MA (partnered with Johnson & Johnson) are testing ways to re-balance the microbiome in people with immune-related gut disorders. Research into the microbiome’s role in diabetes, obesity, heart disease, and other conditions is also well underway.
But Seres hopes to have the first FDA-sanctioned, rigorously developed microbiome product: a secret mix of bacterial spores derived from samples of human feces that, when swallowed, bloom into a healthy community in the gut and leave no room for C. difficile. Its early clinical data were excellent, with 26 of 30 people whose infection wasn’t responding to antibiotics showing no recurrence of the debilitating diarrhea that C. diff causes. Just recently the FDA gave Seres’ lead product SER-109 a “breakthrough” designation, which ensures a speedier review for the treatment than it would have otherwise.
Venture backers have been generous, too, with more than $130 million poured into the company—about half of it from international food giant Nestle.
But its Phase 3 plans, which the company said late last year would start in 2015, have been pushed back. Its regulatory documents now say a Phase 3 trial would likely begin in 2016. (An 87-person Phase 2 trial is currently underway.) That could put FDA approval roughly two years away, although the breakthrough designation might speed things up if all goes well.
Meanwhile, OpenBiome, fueled by charitable donations, has spent a fraction of what Seres has raised to build safety checks into its collection and distribution system. The treatment it provides—fecal microbial transplantation, or FMT—also relies on charitable donations: the poop of healthy volunteers, which OpenBiome minimally processes, stores in freezers (pictured), and ships to more than 300 hospitals and clinics around the country to give to people with infected guts.
Chief medical officer Zain Kassam says with OpenBiome’s stringent standards—30 tests from blood and stool, a waist measurement, body mass index, and a face to face interview—only three of 100 potential donors are allowed to, well, donate. “We have to be extremely conservative,” says Kassam.
The weight-related measurements, for example, are to rule out the speculative possibility that obesity and other metabolic problems could be passed from donor to recipient. (An oft-cited study showed the microbiome of obese people caused skinny mice to gain weight.)
OpenBiome’s typical donor, then, lives in the Boston area and is young and skinny, with a mean age of 26 and body mass index of 23.3. “It’s often people who really like going to the gym,” says the nonprofit’s executive director James Burgess—which, he acknowledges with a laugh, can influence one’s thoughts when seeing a fit person jogging down the street.
OpenBiome has already sent out about 4,500 treatments—sorted into different doses for administration either through a nasal tube or a colonoscopy—to hospitals, clinics, and other practitioners of FMT.