US health officials have approved the first pill made from healthy bacteria found in human waste to fight dangerous gut infections – an easier way of performing so-called fecal transplants.
The treatment from Seres Therapeutics provides a simpler, rigorously tested version of stool-based procedures that some specialists have used for more than a decade.
The US Food and Drug Administration cleared the capsules for adults over 18 who face risks from repeat infections with Clostridium difficile (C diff), a bacteria that can cause nausea, cramping and diarrhea.
C diff is particularly dangerous when it reoccurs, leading to 15,000-30,000 deaths a year. It can be killed with antibiotics but they also destroy good bacteria in the gut, leaving it more susceptible to infection. The new capsules are approved for patients who have received antibiotic treatment.
More than 10 years ago, some doctors began reporting success with fecal transplants – using stool from a healthy donor – to restore the gut’s healthy balance and prevent reinfection.
The FDA approved the first pharmaceutical-grade version of the treatment last year, from Ferring Pharmaceuticals. That company’s product, like most of the original procedures, must be delivered via the rectum.
Series, based in Cambridge, Massachusetts, will market its drug as a less invasive option. The treatment will be sold under the brand name Vowst and comes as a regimen of four daily capsules taken for three consecutive days.
Both the recent FDA approvals are the product of years of research into the microbiome, the community of bacteria, viruses and fungi that live in the gut.
Currently most fecal transplants are provided by a network of stool banks. While the availability of new FDA-approved options is expected to decrease demand, some plan to stay open.
OpenBiome, the largest stool bank in the US, said it will keep serving patients not eligible for the FDA-approved products, such as children and adults with treatment-resistant cases. It has supplied more than 65,000 stool samples for C diff patients since 2013.
“OpenBiome is committed to maintaining safe access to ‘fecal transplantation’ for these patients as a vital last line of defense,” said Dr Majdi Osman, the group’s medical chief.
OpenBiome’s standard stool treatment costs less than $1,700 and is typically delivered as a frozen solution. Seres did not disclose the price it will charge for its capsules.
“We want to make the commercial experience for physicians and patients as easy as possible,” said Eric Shaff, the Seres chief executive. “Ease of administration – in our view – is one of the aspects of the value we’re delivering.”
Seres will co-market the treatment with the Swiss food giant Nestle, which will split the profits. Seres will receive a $125m milestone payment from Nestle in connection with the FDA approval.
Overseeing the stool bank industry has created regulatory headaches for the FDA. In the early days of the trend, the FDA warned consumers about the risk of infection from fecal transplants, as some people sought out “do it yourself” methods.
Seres executives say their manufacturing process relies on techniques and equipment used to purify blood products and other biologic therapies. The company starts with stool provided by donors screened for health risks and conditions. Their stool is likewise tested for dozens of viruses, infections and parasites.
The company then processes samples to remove waste, isolate healthy bacteria and kill other organisms. Thousands of capsules can be made from each sample, making it a more efficient process than current fecal transplants.
The FDA warned in its approval announcement the drug “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens”.
The FDA approved the treatment based on a 180-patient study in which nearly 88% taking the capsules did not experience reinfection after eight weeks, compared with 60% who received dummy pills.
Common side effects included abdominal swelling, constipation and diarrhea.
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