Evolve BioSystems, Inc. and Janssen Research & Development, LLC, are partnering to conduct a study looking at the potential role of B. infantis EVC001 in preventing early childhood atopic dermatitis (AD).
The study will assess the effects of introducing a specific gut bacterium, Bifidobacterium longum subspecies infantis (activated B. infantis EVC001, marketed as Evivo) in inhibiting the onset of AD in the first year of life. The agreement was facilitated by Johnson & Johnson Innovation LLC.
"Atopic dermatitis is not just a debilitating condition for millions of children, but is also a gateway condition associated with numerous chronic conditions that carry a lifelong physical, emotional and financial burden," says David Kyle, PhD, Chairman of the Board and Chief Scientific Officer, Evolve BioSystems, Inc., in a news release. "This study looks to demonstrate whether the introduction of B. infantis EVC001 to the infant gut microbiome will deflect the development of atopic dermatitis and establish a path to lifelong health."
The gut microbiome is made-up of trillions of microorganisms that live in the gastrointestinal tract of newborns. B. infantis is a critical beneficial bacteria required for proper development of the infant gut microbiome. B. infantis EVC001 transforms Human Milk Oligosaccharides (HMOs) into quickly available energy for the intestinal cells. This lowers the gut pH, reducing potential pathogens by 80%. The loss of B. infantis due to C-section delivery and antibiotic use is linked to higher risk for atopic dermatitis, as well as a six-fold higher incidence of allergies and of type 1 diabetes in children.
The study, a proof-of-concept, randomized, double-blind, placebo-controlled, two-arm parallel study, will enroll infants who are less than 15 days old, with a genetic predisposition to allergic conditions, and who are breastfed, with maternal intent to maintain breastfeeding through three months of age. Study participants will be given either daily single doses of a supplement with B. infantis (EVC001) or a placebo for a 12-week period, and then monitored for signs of atopic dermatitis, skin rash, diaper rash and itch over the next 2 years.