Award
NIH Reporter #1R43HD117653-01
Platform technology for delivery of stabilized therapeutic microbes in powders with high water activity
Recipient
VITAKEY, INC.
Award Amount
$349,759.00
Ceiling
$349,759.00
Awarded
May 29, 2025
Identifier
1R43HD117653-01
Award for developing a microbial delivery platform to treat preterm newborns at risk of NEC using patented encapsulation technology to enhance probiotic survival and targeted delivery.
Description
This project involves improving a microbial platform for precision delivery to the intestines with enhanced mucoadhesion. The platform aims to treat preterm newborns at risk for necrotizing enterocolitis (NEC), a leading cause of mortality and morbidity in premature babies. Clinical trials report a 30-50% reduction in NEC occurrence, but variability in dosing, delivery, and effectiveness limits clinical use. A patented encapsulation technology has been developed to protect microbial medicines, increasing gastric survival of probiotic strains Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. Lactis HN019. The technology has demonstrated over a 1-million-fold increase in viable counts after exposure to simulated gastric fluid and maintained viability in milk powder at various temperatures. The project aims to expand the coating technology to materials approved for infant formula, developing the world's first probiotic specifically designed for neonates' GI tracts. Multiple excipients will be tested for gastric stability, targeted intestinal release, shelf stability, and maintenance of microbial viability.