New VOWST Data Published in Nature Medicine and Journal of Infectious Diseases
BRIDGEWATER, N.J. (January 5, 2025) – Nestlé Health Science, a global leader in the science of nutrition, today announced the publication of data detailing the effects of VOWST® (fecal microbiota spores, live-brpk), an orally administered microbiome therapeutic developed to prevent recurrent Clostridioides difficile infection (rCDI), on gut microbiome composition and metabolic activity.
These data, published in the journal Nature Medicine and in the Journal of Infectious Diseases, provide insight into the mechanism of action (MoA) of VOWST and demonstrate clinical efficacy for patients with rCDI. The data show that the restoration of the microbe-associated metabolic functions with VOWST is important to prevent Clostridioides difficile recurrences and to improve outcomes for patients with rCDI.
“Nestlé Health Science is deeply committed to advancing pharmaceutical innovation and delivering transformative solutions for patients and healthcare professionals,” said Luis Briz, President of Professional Health. “These publications are a testament to our dedication to scientific excellence and our ongoing mission to improve outcomes for patients.”
Nature Medicine: Mechanistic Insights into VOWST’s Effects On the Gut Microbiome
Nature Medicine published comprehensive analyses of VOWST’s MoA in patients with rCDI in a manuscript entitled “The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome.” In the analysis of 182 patients from the multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ECOSPOR III; NCT03183128), which examined recurrence of CDI up to 8 weeks as its primary efficacy endpoint, authors found that VOWST is associated with a significant increase in newly appearing beneficial bacterial species, with engraftment levels matching those of healthy controls within 1 week and sustained through 24 weeks. Engraftment of VOWST was consistent regardless of age or antibiotic received immediately before VOWST treatment.
Additionally, treatment resulted in a rapid increase in the richness and abundance of Firmicutes and a reciprocal decline in Proteobacteria, shifting the microbiome profile toward that of healthy individuals. Further analyses revealed VOWST treatment led to increases in key secondary bile acids and short- and medium-chain fatty acids, thought to be inhibitory to Clostridioides difficile growth.
As noted by authors, these data strengthen VOWST’s role in not only preventing rCDI but in potentially restoring the microbe-associated metabolic functions needed to prevent future recurrence. Read more online here.
Journal of Infectious Diseases: Clinical Efficacy in First vs. Multiply Recurrent CDI
The Journal of Infectious Diseases published a subgroup analysis from the Phase 3 open-label, single-arm trial of 263 adults with a history of CDI (ECOSPOR IV, NCT03183141), titled “Comparability of gastrointestinal microbiome and bile acid profiles in patients with first or multiply recurrent Clostridioides difficile infection,” comparing rate of CDI recurrence through week 8 after treatment in patients with first recurrence (frCDI) and multiply recurrent CDI (mrCD). At baseline, microbial diversity was low and bile acid profiles were similar across frCDI and mrCDI groups. At week 1 after VOWST treatment, microbial diversity, VOWST species engraftment and secondary bile acid concentrations increased. Rates of recurrence after VOWST treatment was similarly low in frCDI (6.5%) and mrCDI (9.7%) at 8 weeks, suggesting commonalities in the microbiome disruption of individuals with frCDI or mrCDI.
As noted by study authors, these data “suggest commonalities in microbiome disruption in patients with frCDI and mrCDI that contribute to recurrence and suggest that antibiotics followed by a live microbiome therapy may be an optimal treatment strategy for rCDI, regardless of number of prior CDI recurrences.” Read more online here.
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This press release is intended to provide scientific information regarding newly published research. It is not intended to be promotional. The findings described reflect the results of the referenced study and are not included in the FDA-approved labeling.
About Recurrent Clostridioides difficile Infection (rCDI)
Recurrent Clostridioides difficile infection is a gastrointestinal infection caused by Clostridioides difficile. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased morbidity and mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system1 with the average rCDI-related annual costs per patient at approximately $43K.2
About Nestlé Health Science
Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.com.
1. Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive Study of Costs Associated With Recurrent Clostridium difficile Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI: 10.1017/ice.2016.246
2. U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. https://www.bls.gov/data/inflation_calculator.htm. CPI inflation adjusted to March 2023.