Today, Seres Therapeutics, Inc., and Nestlé Health Science announced Vowst (SER-109; fecal microbiota spores, live-brpk) is now commercially available for the prevention of recurrent Clostridioides difficile infection (rCDI).
Vowst is the first and only orally administered microbiota-based therapeutic to be approved by the US Food and Drug Administration (FDA). Vowst is indicated to prevent rCDI in adults who have already received antibacterial treatment.
“The commercial availability of Vowst provides a new oral dosing option that has demonstrated efficacy in the prevention of further recurrences of rCDI, including those who have experienced a first recurrence,” said We look forward to helping patients who have this potentially life-threatening disease,” said Eric Shaff, president and CEO of Seres.
rCDI is a gastrointestinal infection caused by the C diff bacterium. C diff is present in the gut of most people, but dysbiosis, such as antibiotics wiping out healthy bacteria, enables C diff to flourish. C diff infection can be debilitating, if not fatal, causing diarrhea, stomach pain, fever, loss of appetite, and nausea.
Anywhere from 20-40% of CDI patients experience a recurrent infection, and with each recurrence, the infection become more deadly. Vowst is designed to compete metabolically with C diff and restore the gut microbiota’s colonization resistance. Each orally administered dose of Vowst contains a consortium of highly purified Firmicutes spores from screened and healthy doners, which works to repopulate a healthy and diverse gut microbiome.
In the phase 3 clinical trial ECOSPOR IV, 91.3% of study participants who received Vowst achieved a significant clinical response at week 8. Through week 24, 94.6% of participants maintained this response. The most common adverse reactions, reported in ≥ 5% of Vowst recipients, were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
Vowst was FDA approved on April 26, but as of today, it is available by prescription for adult patients who have received antibiotic treatment for rCDI. Seres Therapeutics and Nestlé Health Science have launched the Vowst Voyage Support Program to help eligible patients reduce out-of-pocket costs and initiate treatment.
