SAFETY PROFILE OF
VOWST
THROUGH 8 WEEKS
VOWST WAS GENERALLY WELL TOLERATED
Incidence of most common adverse reactions compared
to antibiotics alone through 8 weeks1
- The majority of adverse reactions were mild or moderate in severity1
-
Most adverse reactions occurred within 10 days of starting VOWST1
- The median duration of these events was ≤5 days1
- No serious adverse events were considered related to the use of VOWST1
* Safety population consisted of randomized participants who received a dose of study medication and were analyzed according to the treatmentreceived. Data were rounded to the nearest whole number for presentation.
† Solicited adverse events were recorded by participants in a diary for 7 days after completion of the 3-day regimen of VOWST or antibiotics alone.
INCIDENCE OF THE MOST COMMON ADVERSE REACTIONS IN THE OPEN-LABEL STUDY1
The ECOSPOR IV open-label, single-arm trial primary endpoint evaluated the safety and tolerability of VOWST up to 24 weeks2
- All adverse events collected in ECOSPOR IV were unsolicited1
- The majority of adverse reactions were mild to moderate in severity1
* Study population comprised of two cohorts. Cohort 1: 29 participants previously in ECOSPOR III with C. diff recurrence within 8 weeks after VOWST or antibiotics alone. Cohort 2: 234 new participants receiving VOWST with at least 1 C. diff recurrence and responded to C. diff antibiotic therapy. Data were rounded to the nearest whole number for presentation.
REFERENCES: 1. VOWST [Prescribing Information]. Cambridge, MA: Seres Therapeutics, Inc. and Nestlé Health Science. 04/2023. 2. Sims MD, Khanna S, Feuerstadt P, et al. JAMA Network Open. 2023;6(2):e2255758. doi:10.1001/jamanetworkopen.2022.55758.
