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FDA approves first oral faecal-based therapy

The US Food & Drug Administration (FDA) has given the nod to the first oral faecal microbiota product, named Vowst and developed by Seres Therapeutics, for preventing recurrent Clostridioides difficile infections in people over 18, the agency announced last week.

The therapy is for patients who have already received a course of antibiotics for recurrent C. difficile infections, reports MedPage Today.

The treatment, which involves four pills taken once a day for three consecutive days, contains live bacteria from donor faecal matter, with the donors and stool screened for a slew of pathogens. Despite that, the agency still warns that the product carries the potential risk of transmitting infectious agents or food allergens.

“The approval provides patients and healthcare providers with a new way to help prevent recurrent C. difficile infection,” said Dr Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research.

“The availability of a faecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for people who have had this disease that can be potentially life-threatening.”

Approval was supported by the randomised ECOSPOR III trial and an open-label study conducted in the US and Canada.

In ECOSPOR III, which involved 182 patients with recurrent infections but with symptoms under control after a course of antibiotics, patients assigned to the Vowst SER-109 treatment had significantly lower recurrence rates of C. difficile infection through eight weeks compared with those assigned to placebo (12.4% vs 39.8%, P<0.001).

Results were consistent across age groups and largely held up at 24 weeks, at 21.3% in the SER-109 group and 47.3% for the placebo group.

C. difficile infections can cause a host of symptoms (diarrhoea, abdominal pain, fever) and organ failure or death in severe cases.

One of the most common healthcare-associated infections, these infections are linked with anywhere from 15 000 to 30 000 deaths each year.

While standard treatment involves antibiotics, these can alter the microbiome and allow C. difficile to return, and few treatments exist for recurrent infections, which are more likely to affect immunocompromised individuals, people over 65, and those who are hospitalised or living in nursing homes.

“Recurrent C. difficile infection is a highly debilitating and life-threatening disease,” said Dr Carl Crawford of Weill Cornell Medical College, adding that antibiotics alone do not address the underlying cause of recurrent infections – “dysbiosis of the gut microbiome”.

Faecal microbiota products are thought to restore the gut flora, thereby helping prevent further infections.

In December, the FDA approved Rebyota as the first such product for preventing recurrence of C. difficile infections, though Rebyota needs to be administered rectally.

“The approval of Vowst provides an important new oral treatment option for this disease,” Crawford added.

In trials, the most commonly reported side effects with SER-109 that occurred at a rate higher than with placebo included abdominal bloating, fatigue, constipation, chills, and diarrhoea, the FDA noted.

The product is expected to be available by June.


NEJM article – SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection (Open access)


Clinical article – ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection (Open access)


MedPage Today article – FDA OKs First Poop-Based Oral Therapy (Open access)


See more from MedicalBrief archives:


Faecal transplantation beats antibiotics for CDI, pharmaceuticals company reports


FDA issues ‘serious risk’ alert on on faecal transplants


The war over faecal microbiota transplants


Therapeutic donor microbes remain long after faecal microbiota transplantation





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