Seres Therapeutics’ pill for C. difficile infections gains FDA approval in the US

USA — The United States Food and Drug Administration (U.S. FDA) has given approval to a new pill, made from healthy bacteria found in human waste, to combat dangerous gut infections in patients.

This new treatment, developed by Seres Therapeutics, is a simplified and rigorously tested version of stool-based procedures that medical specialists have been using for more than a decade to assist patients.

The Food and Drug Administration has authorized the use of capsules for adults over 18 years of age, who face the risk of recurring infections with the bacteria Clostridium difficile, which can cause severe nausea, cramping, and diarrhea.

Clostridium difficile (C. diff)is particularly dangerous when it reoccurs, leading to between 15,000 and 30,000 deaths per year.

While antibiotics can kill C. diff, they also destroy good bacteria that reside in the gut, making it more vulnerable to future infections.

The new capsules are approved for patients who have already undergone antibiotic treatment.

Over 10 years ago, some doctors began reporting successful results with fecal transplants, which involve the use of stool from a healthy donor to restore the gut’s healthy balance and prevent reinfections.

The FDA approved the first pharmaceutical-grade version of the treatment last year from a rival drugmaker, Ferring Pharmaceuticals.

However, Ferring’s product, like most of the original procedures, must be delivered through the rectum. Seres Therapeutics, 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 of the recent FDA approvals are the result of years of pharmaceutical industry research into the microbiome, which is the community of bacteria, viruses, and fungi that reside in the gut.

Most fecal transplants are currently provided by a network of stool banks that have popped up at medical institutions and hospitals across the country.

While the availability of new FDA-approved options is expected to decrease demand for donations from stool banks, some plan to stay open.

OpenBiome, the largest stool bank in the US, has supplied over 65,000 stool samples for C. diff patients since 2013 and plans to continue serving patients who are not eligible for FDA-approved products, such as children and adults with treatment-resistant cases.

Seres Therapeutics will co-market the treatment with Swiss food giant Nestle, which will also share the profits. In connection with the FDA approval, Seres will receive a US$125 million milestone payment from Nestle.

The fledgling industry of US stool banks has created regulatory headaches for the FDA, which does not traditionally police homemade products and procedures used in doctor’s offices.

In the early days of the trend, the FDA warned consumers about the risks of potential infections from fecal transplants, as some people sought out questionable “do it yourself” methods from videos and websites.

Seres executives assert that their manufacturing process relies on the same techniques and equipment used to purify blood products and other biologic therapies.

The company starts with stool provided by a small group of donors who are screened for various health risks and conditions.

Their stool is tested for dozens of potential viruses, infections, and parasites. The company then processes the samples to remove the waste, isolate the healthy bacteria, and kill any other lingering organisms.

Thousands of capsules can be made from each stool sample, making it a more efficient process than current fecal transplants, according to the company.

The FDA has warned in its approval announcement that the drug “may carry a risk of transmitting infectious agents.

It is also possible for Vowst to contain food allergens,” the agency noted. The FDA approved the treatment based on a 180-patient study in which nearly 88% of patients taking the capsules did not experience reinfection.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.