SER-109 (VOWST) is the first FDA-approved oral microbiome therapy designed to prevent recurrent Clostridioides difficile infection (CDI) in adults following standard antibiotic treatment. In the phase III ECOSPOR III trial, SER-109 significantly reduced the risk of CDI recurrence at 8 weeks post-treatment, with sustained benefits observed at 6 months. The treatment also improved health-related quality of life compared to placebo. SER-109 demonstrated a favorable safety profile, with most adverse events being mild to moderate and primarily gastrointestinal in nature. Its oral formulation and lack of refrigeration requirements further enhance its accessibility and ease of use.
CDI, caused by toxin-producing bacteria disrupting the large intestine, often recurs after antibiotic treatment due to microbiome disruption. SER-109 addresses this by repairing the gut microbiome, reducing the likelihood of subsequent infections. Clinical data highlight its effectiveness and tolerability, making it a valuable addition to CDI management. For patients recovering from recurrent CDI, SER-109 offers a convenient and innovative solution to break the cycle of infection and recurrence, supporting both clinical recovery and long-term quality of life improvements.
Reference: Blair HA. SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection. Drugs. 2024 Mar;84(3):329-336. doi: 10.1007/s40265-024-02006-7. Epub 2024 Mar 5. PMID: 38441806.
