GlyCare™ 2FL/DFL Overview

GlyCare™ 2FL/DFL will be available as a mix of 2'FL and DFL. 

2'FL (2'fucosyllactose) is the most abundant fucosylated Human Milk Oligosaccharide (HMO) in human milk at ~2g/L1 and can positively impact the health of infants: 

  • A protective role; preventing infection of the gut
  • Improve gut barrier and immune regulation
  • Important for cognitive development

DFL (DiFucosyllactose or Lactodifucotetraose, LDFT) is a highly abundant fucosylated HMO in human milk. Some primary known benefits of DFL include reducing infection by inhibiting the adhesion of pathogenic bacteria and positively supporting gut health by selectively stimulating bifidobacteria. 

GlyCare™ 2FL/DFL will be available as a mix of 2'FL and DFL in a ratio close to the composition naturally found in breast milk. GlyCare™ 2FL/DFL has been approved as a Novel Food in Europe and regulatory filings have been made in the US. Preparation is on way for other major markets. 

GlyCare™ 2FL/DFL will be commercially available from 2020.

<p>Immunity and Infections</p>

Immunity and Infections

HMO help support immunity. Clinical studies have reported a relationship between HMO and immune outcomes in infants. HMO are reported to support an infant’s immune system. HMO may help reduce the risk of infection. HMO may help reduce the risk of certain infections in infants. Specific HMO (such as 2’FL) may reduce the incidence of certain infections in breastfed infants. 

Addition of 2’FL/2’FL + LNnT to infant formula* has been clinically reported to help support the immune system. Infant formula containing 2’FL/2’FL + LNnT may help to reduce the incidence of certain (parent-reported) infections and illnesses. Infant formula containing 2’FL + LNnT has been reported to reduce the incidence of (parent reported) respiratory tract infections, anti-fever medication, and antibiotics. Clinical data suggest infant formula with 2’FL/2’FL + LNnT help support immunity. 

*HMO in infant formula is dependent on the levels of 2’FL +/- LNnT supplemented into the formula.

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<p>Gut Health and Microbiota</p>

Gut Health and Microbiota

Clinical data suggest HMOs support intestinal health in infants. Preclinical and clinical data indicate that HMOs support the growth of beneficial bacteria/bifidobacteria. Certain HMOs such as 2’FL may help establish bifidobacterial populations in the infant gut. HMOs may help support the growth of beneficial bacteria/bifidobacteria which are believed to be important for immune and intestinal development and health. (Specific HMOs such as) 2’FL may help reduce the risk of diarrhea in breastfed infants.

Infant formula with 2’FL and LNnT has been reported to support growth of beneficial bacteria / bifidobacteria. Clinical results indicate that 2’FL + LNnT help bring the intestinal micobiome of formula fed infants closer to that of breastfed infants. 2’FL + LNnT may help bring the intestinal microbiota of infants born by C-section closer to those born vaginally. 

<p>Brain and Cognitive Development</p>

Brain and Cognitive Development

Pre-clinical data in rodent models indicate 2’FL may support cognitive development/may support learning and memory.

Associational data from a small observational infant study indicated that 2’FL concentration of breast milk at 1 month of age (but not 6 months of age) correlated with cognitive development scores at 24 months of age. 

<p>Hypoallergenicity</p>

Hypoallergenicity

An extensively hydrolyzed whey-based formula containing 2’FL and LNnT has been shown to be hypoallergenic.

An extensively hydrolyzed whey-based formula containing 2’FL and LNnT met the AAP criteria for hypoallergenicity.

Note that hypoallergenicity at levels above those studied (1.0 g/L and 0.5 g/L) may need to be assessed.

<p>Allergy Development</p>

Allergy Development

Emerging data from pre-clinical models and breast milk studies suggest that HMOs may play a role reducing the incidence of certain allergic manifestations.

Emerging associational and intervention data from recent clinical studies have suggested that 2’FL may play a role in reducing the risk for eczema.

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