Significant Reduction in Pathogenic Gut Bacteria Lowers Potential for Infection Risk in Infants Fed B. infantis EVC001

DAVIS, Calif., July 18, 2018 /PRNewswire/ -- Evolve BioSystems, Inc. (www.evolvebiosystems.com) announced publication of a study showing that two weeks of supplementation with Bifidobacterium longum subsp. infantis EVC001 (B. infantis EVC001, currently available to consumers as Evivo^® baby probiotic) in breastfed infants led to an 85 percent reduction in virulence factor genes, the tools which enable pathogens to thrive and cause infection in humans. The paper, published in Human Microbiome Journal, (read the article at https://www.sciencedirect.com/science/article/pii/S2452231718300137) is the first study to report a significant reduction of virulence factors in the infant gut bacterial community by way of a targeted probiotic supplementation. Among other findings, the study shows common pathogenic bacterial species being reduced by at least 93 percent.

"The neonatal population is particularly susceptible to microbial infections. Microbes that express virulence factors can establish persistent reservoirs in the hospital environment and colonize newborn infants," said Brian Scottoline, M.D., Ph.D., associate professor of pediatrics (neonatology) in the Oregon Health & Science University School of Medicine and OHSU Doernbecher Children's Hospital. "Reducing virulence factors in newborns has the potential for lifelong health benefits to this particularly vulnerable population—it's tantamount to starting life out on the right foot."

Cutting off the "lifeline" for pathogens
Virulence factors enable pathogenic bacteria to infect the host, allow them to resist the host immune system or obtain nutrients from the host. The study by Evolve BioSystems showed that after two weeks of breastfeeding, in conjunction with B. infantis EVC001, there was a reduction in the abundance of virulence factor genes, primarily through the reduction of common pathogens such as E. coli, C. difficile, Klebsiella pneumoniae, and Streptococcus pneumoniae by over 93 percent.

"Historically it's been difficult to identify effective options that minimize the spread of virulence factors," said study author, Dr. Giorgio Casaburi. "In a previous publication, we showed that supplementation with Evivo (B. infantis EVC001) achieved persistent colonization of the gut with the key beneficial bacteria B. infantis. The new study shows that this is a powerful option for dramatically reducing the total level of virulence factors in the infant gut, and potentially providing protection to infants against infection by these pathogens."

Details of the study
The clinical study, a collaboration between UC Davis Medical Center and Evolve BioSystems, looked at 60 healthy, exclusively breastfed term infants in the Northern California area. Half received B. infantis EVC001 once per day along with breastmilk for three weeks, the others received breastmilk alone. The Evolve team analyzed infant stool using shotgun metagenomics—which allows for comprehensive characterization of all microbial genes in any given sample—showing:

• Bifidobacterium colonization was achieved after only two weeks of feeding B. infantis EVC001, leading to a reduction in virulence factor genes by 85%.
• The levels of total Bifidobacterium were inversely correlated with abundance of virulence factors--i.e. the more Bifidobacterium, the fewer virulence factors.
• The reduction in pathogenic bacteria lasted up to 60 days, a full month beyond supplementation with B. infantis EVC001, as shown in previously published data from this clinical trial.

About Evolve BioSystems
Evolve BioSystems, Inc. is a privately-held microbiome company dedicated to developing the next generation of products to establish, restore, and maintain a healthy gut microbiome. Evolve is a spin-out from the Foods for Health Institute (FFHI) at the University of California, Davis and builds on more than a decade of research into understanding the unique partnership of the infant gut microbiome and breast milk components. Having led to the development and commercial launch of products to resolve newborn gut dysbiosis, including Evivo^® for infants and GlycoGuard^® for nursing foals and pigs, Evolve's discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle as well as other animal species. In addition to the landmark proof-of-concept trial, Evolve is undertaking further clinical studies to build out its suite of microbiome-based solutions.

SOURCE Evolve BioSystems, Inc.

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