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New clinical data demonstrate safety and tolerability of activated B. infantis

June 05, 2017

Evolve BioSystems, Inc., a microbiome company committed to developing novel solutions to restore and maintain a healthy newborn gut microbiome, today announced Phase I clinical trial data demonstrating the safety and tolerability of supplementation with an activated form of the beneficial bacteria Bifidobacterium longum subsp. infantis (B. infantis) in breastfed infants. The data show that supplementation with activated B. infantis EVC001 is safe and tolerable with no difference in adverse events between infants who were supplemented and those who were not. The findings were published this week in the journal BMC Pediatrics.

Bifidobacteria, including B. infantis, have historically dominated the intestinal microbiome of breastfed infants and continue to do so in developing countries. However, in developed countries, like the US, the rate of Bifidobacteria colonization is significantly lower. Research shows that the infant gut microbiome plays a critical role in the development of a healthy immune system and the accurate setting of metabolic set points, in addition to meeting the infant's dietary needs.

"This study shows that supplementation with activated B. infantis in combination with breast milk is safe and well tolerated in infants," said David Kyle, CEO of Evolve BioSystems. "We look forward to making activated B. infantis EVC001 commercially available in the upcoming months to provide infants with a foundation for life-long health."

The IMPRINT trial was a parallel, partially-randomized, controlled two-month, Phase 1 study that included 68 mother-infant pairs who were randomized to receive either lactation support plus supplementation with activated B. infantis EVC001 or lactation support alone. The supplementation period began seven days after infant delivery and lasted for 21 days. There were no safety and tolerability differences in the two groups at any point in the study across endpoints including in flatulence, bloody stool, body temperature, ratings of gastrointestinal symptoms, use of antibiotics or gas-relieving medications, infant colic, jaundice, number of illnesses, sick doctor visits or diagnoses of eczema.

Initial results also suggest that supplementation with activated B. infantis EVC001 leads to significant colonization of the infant gastrointestinal tract. The mean log10 change in fecal Bifidobacteria from Day 6 to Day 28 was significantly higher (6.6 ± 2.8 SD, p=0.0002) in infants who were supplemented than for infants receiving lactation support alone (3.5 ± 3.5 SD). Infants supplemented with activated B. infantis EVC001 experienced a significant decrease in the number of watery stools per day, as well as an increase in the number of soft stools per day by 36% (p<0.005) over baseline. There were no significant changes in stool in infants receiving lactation support only.

"The initial clinical safety and tolerability results from the IMPRINT trial are very encouraging and pave the way to restoring the infant gut microbiome to a more healthy state much like that of our ancestors," said Mark Underwood, M.D., Chief of the Division of Neonatology at UC Davis Children's Hospital, a scientific collaborator of Evolve BioSystems and principle investigator of the study. "In combination with breast milk, B. infantis EVC001 has the potential to establish a beneficial gut microbiome, driving critical metabolic and immune programming for infants."
About the IMPRINT trial

The IMPRINT trial (NCT02457338) was a parallel, partially-randomized, controlled two-month study. Sixty-eight mother-infant pairs were randomized to receive either lactation support alone or lactation support plus B. infantis EVC001 supplementation for their infants.

Infants randomized in the supplemented group received one daily serving of B. infantis EVC001 in their homes for 21 consecutive days starting on day seven after birth and continuing through day 27. Each daily serving of activated B. infantis EVC001 (was up to 2.8 x 1010 CFU). Mothers collected infant stool samples from their infants' diaper before day 6 (baseline) and on days 10, 14, 21, 25, 29, 32, 40, 50 and 60. On days 7, 15, 22, 33 and 61 study personnel visited mothers' homes to conduct study procedures. On all six visits, mothers filled out questionnaires about their infants' health, gastrointestinal symptoms, occurrence of fever, illness and number of reasons for sick doctor visits. Infant stool samples without labeled group assignments were provided to Evolve BioSystems for the analysis of total infant fecal Bifidobacterium.

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 newborn 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 discovery and development of products to resolve infant gut dysbiosis, Evolve's discovery platform is now being applied to solving gut dysbiosis throughout the human life cycle as well as in various animal species. Evolve completed a $9 million Series A capital raise in 2015, followed by an additional $20 million Series B capital raise in 2017. Evolve has now completed a landmark proof-of-concept study demonstrating the efficacy of its initial proprietary offering, and is undertaking further clinical studies to build out a portfolio of microbiome-based solutions to support the lifelong health of newborns worldwide.

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