– Data from Phase 3 open-label single-arm study of VOWST found nearly 95% of individuals with a clinical response at 8 weeks remained free of CDI through Week 24, regardless of number of prior C. difficile infections (CDI) –
– Results from ECOSPOR IV add to data from ECOSPOR III Phase 3 study and together supported the recent VOWST FDA approval –
CAMBRIDGE, Mass. & HOBOKEN, N.J.--(BUSINESS WIRE)-- Seres Therapeutics, Inc. (Nasdaq: MCRB), and Nestlé Health Science today announced the presentation of data from the Phase 3 open-label ECOSPOR IV study evaluating VOWST (fecal microbiota spores, live-brpk) – the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic for the prevention of recurrence in adults with recurrent C. difficile (rCDI) following antibacterial treatment. VOWST is not indicated for the treatment of CDI. These data are shared as oral and poster presentations at the 2023 Digestive Disease Week® (DDW 2023) Annual Meeting being held in Chicago, Ill. on May 6-9.
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“In the ECOSPOR IV Phase 3 open-label single-arm study, high clinical response rates were achieved at week 8 and continued into week 24 following VOWST treatment, regardless of the number of prior CDI infections,” said Lisa von Moltke, M.D., Chief Medical Officer at Seres. “These results add to previous positive data from the randomized, placebo-controlled ECOSPOR III Phase 3 study. We are excited that VOWST is now approved by the FDA for the prevention of recurrent CDI following antibacterial treatment for rCDI, including in first recurrence patients.”
On April 26, VOWST was approved by the FDA for the prevention of recurrence of C. difficile infection in adults with rCDI following antibacterial treatment. The FDA approval of VOWST was supported by a robust Phase 3 development program that included the ECOSPOR III (NCT03183128) and ECOSPOR IV (NCT03183141) studies. VOWST was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA.
The data being presented at DDW include safety and efficacy data from the ECOSPOR IV study, an open-label extension study of ECOSPOR III and an open-label program evaluating VOWST in 263 adults with rCDI. ECOSPOR IV study enrolled participants with characteristics commonly seen in routine clinical practice. ECOSPOR IV results were published in JAMA Network Open1 in February 2023. Results from ECOSPOR III were published in the New England Journal of Medicine2 in January 2022.
Presentation Titles and Summaries:
Durability of the Clinical Response to SER-109, an Investigational Oral Microbiome Therapeutic, in a Phase 3 Open-Label Trial (ECOSPOR IV) in Patients with Recurrent Clostridioides Difficile Infection (Oral Presentation #694)
In the overall population of the ECOSPOR IV study (n=263), 91.3% of participants who received VOWST achieved clinical response at Week 8 and 94.6% of those participants maintained a response through Week 24. In participants with a first recurrence, response rates to VOWST were similar to the overall population with 93.5% of participants achieving a clinical response at Week 8 and 94.4% of those participants maintaining the response through Week 24. Further, in participants with two or more recurrences, 90.3% achieved a clinical response at Week 8 and 94.6% of those participants maintained that response through Week 24. These response rates were observed through Week 24, regardless of number of prior CDI recurrences.
Study populations included participants with multiple comorbidities. The most common adverse events were mild to moderate in severity and transient in nature.
Results from an Open-Label Study (ECOSPOR IV) to Evaluate the Safety and Efficacy of SER-109, an Investigational Oral Microbiome Therapeutic, in Adults with Recurrent Clostridioides Difficile Infection (rCDI): A Subgroup Analysis (Poster Presentation #Su1873)
In a post hoc subgroup analysis by select baseline characteristics, the following rates of rCDI were observed at Week 8 across all subgroups: all participants (8.7%), participants with first recurrence (6.5%) vs. those with 2 or more recurrences (9.7%), participants