Helicobacter pylori has evolved alongside humans in the stomach for the past 60,000 years.1 To survive in this niche, H. pylori modulates the immune system of its host.
Extensive epidemiological data support a relationship between the precipitous decrease in the incidence of H. pylori infection in developed countries and a concomitant rise in allergic disease of epidemic proportions. Paediatric allergy frequently manifests in the first few months of age as atopic dermatitis (also known as eczema) and may progress to include food allergies, allergic asthma, allergic rhinitis and other allergic conditions.
Several research groups, including Ondek’s scientists, have demonstrated experimentally that H. pylori modulates the host’s immune system to protect against the allergic response.
ImmBALANCE® is a patented therapeutic candidate in development for the management of paediatric allergy. Our product, ImmBALANCE®, is a killed cell-free form of a proprietary strain of H. pylori that has been shown to protect against allergy in animal models.
Ondek® has developed a fermentation process that allows us to grow large volumes of a proprietary strain of the bacteria. We then kill and process the bacteria in a way that retains its immunomodulatory properties and meets the regulatory requirements for pharmaceutical drug development.
Ondek is developing ImmBALANCE® to reduce the incidence of childhood allergy. Eczema and food allergies are the first signs of allergic disease in children. ImmBALANCE® will initially be used to reduce food allergy and disease severity of eczema in infants.
Eczema is an allergic disorder affecting 11% of children in the USA and >20% in some other developed countries, including Australia.2 Infants with moderate to severe eczema have a greater than 50% risk of manifesting food allergies at 12 months of age, and greater risk of developing asthma and allergic rhinitis later in life.3, 4, 5 Further clinical trials will explore the potential of early intervention with ImmBALANCE® to prevent individuals at higher risk from developing allergies later in life.
ImmBALANCE® will be orally administered and may be formulated as a powdered product that can be dissolved in drinks or foods or, as tablets or capsules. It is envisaged that daily dosing for specified periods will prove most effective.
1 Linz et a.l – Gut Liver (2012) Evolutionary History of the Helicobacter pylori Genome: Implications for Gastric Carcinogenesis.
2 Pawankar R, Canonica GW, ST Holgate ST, Lockey RF, Blaiss M. The WAO White Book on Allergy (Update. 2013)
3 Tsakok T, Marrs T, Mohsin M, Baron S, du Toit G, Till S, et al. Does atopic dermatitis cause food allergy? A systematic review. J Allergy Clin Immunol. 2016;137(4):1071-8.
4 Zheng T, Yu J, Oh MH, Zhu Z. The atopic march: progression from atopic dermatitis to allergic rhinitis and asthma. Allergy Asthma Immunol Res. 2011;3(2):67-73.
5 Martin PE, Eckert JK, Koplin JJ, Lowe AJ, Gurrin LC, Dharmage SC, et al. Which infants with eczema are at risk of food allergy? Results from a population-based cohort. Clin Exp Allergy. 2015;45(1):255-64.