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SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection

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Abstract

SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a live biotherapeutic product indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in patients 18 years of age and older following standard of care (SOC) antibacterial treatment for recurrent CDI. It is a purified bacterial spore suspension sourced from healthy donors. As the first oral faecal microbiota product approved for prevention of recurrent CDI, SER-109 is administered as four capsules once daily for three consecutive days. In a well-designed, placebo-controlled, phase III trial (ECOSPOR III), SER-109 significantly reduced the risk of recurrent CDI at 8 weeks post-treatment, with a durable response seen at 6 months post-treatment. Treatment with SER-109 was also associated with rapid and steady improvement in health-related quality of life compared with placebo. SER-109 was generally well tolerated, with a safety profile similar to that of placebo. The most common adverse events were of mild to moderate severity and generally gastrointestinal in nature. Thus, with the convenience of oral administration and lack of necessity for cold storage, SER-109 is a valuable option for preventing further CDI recurrence in adults following antibacterial treatment for recurrent CDI.

Plain Language Summary

Clostridioides difficile is a type of bacteria that can produce toxins leading to infection of the large intestine. Symptoms of C. difficile infection (CDI) range from mild diarrhoea to severe life-threatening sepsis. Treatment is usually antibiotics to kill the toxin-producing bacteria and resolve symptoms. However, antibiotics can disrupt the gut microbiota and leave individuals at risk of CDI recurrence. SER-109 (VOWST™; fecal microbiota spores, live-brpk) is a microbiome therapy containing purified live bacterial spores extracted from donated human faecal matter intended to repair the microbiome. It is given as four oral capsules per day over three consecutive days to prevent the recurrence of CDI in adults following standard antibiotic treatment. In a phase III clinical trial, patients with recurrent CDI who received SER-109 had a significantly lower rate of CDI recurrence at 8 weeks than those who received placebo, and this response was sustained through 6 months. SER-109 was generally well tolerated, and most adverse events were mild or moderate in severity. With the convenience of oral administration and no refrigeration requirements, SER-109 is a valuable option for preventing further CDI recurrence in adults who have received antibiotics for recurrent CDI.

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Acknowledgments

During the peer review process, the manufacturer of SER-109 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

Authorship and Conflict of Interest

Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

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Not applicable.

Additional information

The manuscript was reviewed by: J. M. Blondeau, Department of Clinical Microbiology, Royal University Hospital, Saskatchewan Health Authority and University of Saskatchewan, Saskatoon, SK, Canada; K. W. Garey, College of Pharmacy, University of Houston, Houston, TX, USA; E. J. C. Goldstein, Infectious Diseases, RM Alden Research Laboratory, Santa Monica University of California, Santa Monica, CA, USA.

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Blair, H.A. SER-109 (VOWST™): A Review in the Prevention of Recurrent Clostridioides difficile Infection. Drugs 84, 329–336 (2024). https://doi.org/10.1007/s40265-024-02006-7

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