WASHINGTON – On Wednesday, US health officials approved the first pill to combat dangerous intestinal infections made from healthy bacteria found in human waste. This is a simpler way of performing the so-called fecal transplant.
Seres Therapeutics’ new treatment offers a simpler, rigorously tested version of the fecal-based procedure that some medical professionals have used for over a decade to help their patients.
The Food and Drug Administration has cleared capsules for adults 18 and older who face the risk of repeated infections with Clostridium difficile, a bacterium that can cause severe nausea, cramps and diarrhea.
Recurrences of C. diff are particularly dangerous, causing 15,000 to 30,000 deaths annually. Antibiotics can kill them, but they also destroy the good bacteria that live in your gut, making them more susceptible to future infections. Approved.
Over a decade ago, some doctors began reporting successful fecal transplants using faeces from healthy donors to restore a healthy balance in the gut and prevent reinfection.
Last year, the FDA approved the first pharmaceutical-grade treatment from rival pharmaceutical company Ferring Pharmaceuticals. However, that company’s products, like most of the original procedures, must be delivered via the rectum.
Based in Cambridge, Massachusetts, Seres plans to market its drug as a less invasive option. The treatment is marketed under his Vowst brand name and comes as a regimen of four capsules a day taken for three consecutive days.
Both recent FDA approvals are the result of years of pharmaceutical industry 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 that have emerged in medical institutions and hospitals across the country.
As new FDA-approved options become available, demand for donations from fecal banks is expected to decrease, but some will remain open.
OpenBiome, the largest flight bank in the United States, said it will continue to serve patients who are not eligible for FDA-approved products, such as children and adults with refractory cases. Since 2013, he has provided over 65,000 stool samples for C. diff patients.
“OpenBiome is committed to maintaining safe access to ‘fecal transplants’ for these patients as a critical last line of defense,” said Dr. Majidi Osman, medical director of the group. I’m here.
OpenBiome’s standard stool processing costs less than $1,700 and is typically delivered as a frozen solution within days of ordering. Seres did not disclose the price it will charge for the capsules in a statement Wednesday night.
The company’s chief executive, Eric Shaff, said in an interview prior to the announcement: “From our point of view, ease of management is one aspect of the value we offer.”
Ceres will co-market the treatment with Swiss food giant Nestlé, which will share profits. Seres will receive a $125 million milestone payment from Nestle in connection with the FDA approval.
Overseeing the emerging industry of US flight banks is a regulatory headache for the FDA, which has not cracked down on homemade products and procedures traditionally used in doctors’ offices. Early in this trend, the FDA warned consumers about the potential risk of infection from fecal transplants, as some people sought questionable “do-it-yourself” methods from videos and websites.
Seres executives say their manufacturing process relies on the same technology and equipment used to purify blood products and other biological therapies.
The company will start with flights provided by a small group of donors who have been screened for various health risks and conditions. Their stool is similarly tested for dozens of potential viruses, infections and parasites.
The sample is then processed to remove waste, isolate healthy bacteria, and kill remaining organisms. According to the company, thousands of capsules can be made from each fecal sample, making it a more efficient process than current fecal transplants.
In its approval announcement, the FDA said the drug “may carry the risk of transmitting infectious agents. Vowst may also contain food allergens,” the agency noted.
The FDA approved this treatment based on a study of 180 patients. In this study, nearly 88% of the patients who took the capsules experienced no reinfection after her eight weeks, compared to 60% of those who took the dummy pill.
Common side effects include abdominal swelling, constipation, and diarrhea.
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This story has been corrected, Eric Shaff is the Chief Executive Officer of Seres Therapeutics, not the Chief Financial Officer.
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The Associated Press’ Health Sciences Division is supported by the Scientific and Educational Media Group at the Howard Hughes Medical Institute. AP is solely responsible for all content.
