New Clinical Data Demonstrate Safety And Tolerability of Activated B. Infantis


Medicine, Health Care New Clinical Data Demonstrate Safety…

Published: June 5, 2017.
Released by Weber Shandwick  

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% (p0.005) 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.”


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