On April 26, 2023, a groundbreaking milestone was achieved as the U.S. Food and Drug Administration (FDA) granted approval for the very first pill designed to replicate the effects of fecal transplants. Named “Vowst,” this innovative treatment is crafted using healthy bacteria to combat the recurrence of Clostridium difficile (C. diff) infection in adults who have undergone antibacterial therapy for recurrent C. diff infections.
In the FDA statement, Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research, said, “Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection.”
“The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening,” said Dr. Marks.
- Diff Infection Causes Between 15K to 30K Deaths Annually
- diff infection stands as one of the most prevalent healthcare-associated infections. It inflicts severe symptoms including persistent nausea, excruciating cramping, and debilitating diarrhea.Professor of pathology and infectious diseases at Stanford Medicine in Palo Alto, California, Niaz Banaei, MD, who was not involved in the development of Vowst, said, “When the community of microorganisms inhabiting the gut and supporting our health is disturbed with antibiotics — usually prescribed for the treatment of unrelated medical issues — C. difficilecan expand in numbers and produce toxins that can damage the lining of the large gut.”
If not managed properly, this condition can lead to dangerous complications, including gut inflammation and, in some traffic cases, death, explains Dr. Banaei. He goes on to say that approximately 15,000 to 30,000 people die of C. diff every year.
He also goes on to say that sadly, this disease process can recur due to particular members of the gut microbial community having vanished. Aside from taking antibiotics, other risk factors for recurrent CDI include the following:
- Being older than 65
- Being hospitalized
- Living in an assisted care facility
- Being immunocompromised
- A previous history of CDI
Revolutionary Treatment to Restore Gut Health
Dr. Banaei also says, “Fecal microbiota transplant restores the gut microbial community back to a healthy state and reverses the pathologic state that occurred as a result of the disruption.”
Over 10 years ago, doctors were successful at treating recurrent CDI using fecal transplants, which happens to be a procedure that involves taking healthy bacteria from the feces of screened donors and transferring them to the colon of the recipient. This was usually done through a colonoscopy.
“Fecal microbiota transplant has been shown to be highly effective in restoring the gut microbiota and preventing recurrence of CDI,” says Dr. Banaei.
The Vowst treatment is hoping to be able to offer the same benefits, which is to restore the gut flora to prevent recurrent CDI episodes, except using oral capsules rather than having to undergo a whole procedure.
Again, carefully screened donors – plus meticulous manufacturing and quality control – are all a part of producing the capsules, says Carlo Tanzi, PhD, head of investor relations and corporate communications for Seres Therapeutics, the company that makes Vowst.
Once stool samples are collected and tested, they’re then processed to remove the waste, isolating the healthy bacteria and killing any other remaining organisms. From each stool sample, thousands of capsules can be manufactured, making it a more efficient process than the current fecal transplants being used, explains Seren Therapeutics.
Almost 9 in 10 People Using Vowst Didn’t Have Reinfection Within 8 Weeks
The FDA approval of Vowst was based on the phase 3 study published on January 20, 2022 in the New England Journal of Medicine.
Out of the 182 participants, 88 percent of those whom took the capsules didn’t experience reinfection after eight weeks. This was compared to 60 percent of those who were given placebo. At six months post treatment, 79 percent of the Vowst group were also recurrence-free, as compared with the 53 percent of the placebo group.
“The FDA approval of fecal capsules will simplify restoration of the gut microbiota and will make the intervention more accessible,” says Dr. Banaei.
Meanwhile, Dr. Tanzi explains that ‘this is an important advancement for those who suffer from the estimated nearly 156,000 episodes of recurrent CDI in the United States each year.’
“These patients often suffer debilitating symptoms, like frequent diarrhea up to 15 times a day, which prevent them from participating in their normal daily activities. Patients often are unable to leave the house, go to work, and spend uninterrupted time with loved ones,” he says.
Is Vowst Safe?
During the clinical trials, participants experienced some side effects acutely, such as fatigue, constipation, abdominal bloating, chills, and diarrhea. However, overall, the medication didn’t raise safety concerns, explains Dr. Banaei.
But, according to the FDA statement, the agency did note that Vowst “may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens.”
Availability, Dosing and Price of Vowst
When it comes to the proper dosing regimen of Vowst, it’s said to be four capsules taken orally once a day, for three consecutive days. According to the product website, this therapy was already made available at the beginning of June 2023.
The list price of Vowst is $17,500, according to a company presentation. However, the actual cost of the medication to consumers will depend on their insurance coverage.
Looking At More Treatments That Work Through the Microbiome
Experts share that it will also be interesting to see what other patient populations with disrupted gut microbiota, but non-C. diff diarrhea, may also benefit from the Vowst medication, says Dr. Banaei.
The manufacturers of this treatment also believe that there could be many more opportunities that will arise to create new treatment modalities through the microbiome, and not just to treat recurrent CDI, but really other areas where the microbiome has a direct connection to human health.
As explained by Dr. Tanzi, the company is continuing to look at new products, like the investigational therapy created to reduce the incidence of gastrointestinal antibiotic-resistant infections, bacteremia, and graft-versus-host disease (GvHD) in patients who are immunocompromised, which includes patients that are getting allogeneic hematopoietic stem cell transplantation (HSCT).
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