Anti-gluten egg yolk antibodies for the treatment of celiac disease

#The present invention generally relates to pharmaceutical or nutraceutical compositions comprising anti-gluten antibodies and methods for producing and using such antibodies. The compositions may comprise whole egg yolk, or processed egg yolk, or isolated or purified fractions of the egg yolk, and may be used in the active or prophylactic treatment of celiac disease.

#Celiac disease (also known as celiac sprue, non-tropical sprue or gluten-sensitive enteropathy) is a common autoimmune condition triggered by ingesting wheat proteins called gluten. In cereal grains and flour, such as wheat, rye or barley, gluten is a complex mixture of proteins including alcohol-soluble monomers called gliadins and alcohol-insoluble polymers called glutenins. Gliadins can be divided into alpha, gamma and omega types on the basis of their amino acid sequences and mobility on electrophoresis. The glutenin subunits can be divided into high molecular weight (HMG) and low molecular weight (LMG) groups.

#The clinical spectrum of gluten sensitivity includes typical celiac disease associated with the classical features of fatigue, chronic diarrhoea, malabsorption of nutrients, weight loss, abdominal distension, anaemia, as well as a failure to thrive in young children.

#The invention will now be described by way of exemplary embodiments with reference to the accompanying drawings. In the drawings:

#FIG. 1 is a block diagram showing a process of producing antibodies against gluten proteins and preparing antibodies for the treatment of celiac disease, according to the present invention.

#FIG. 2 is a line graph showing a titer of antibodies from egg yolk of hyperimmunized laying hens during the immunization period.

#The present invention provides for pharmaceutical or nutraceutical compositions for treating patients with celiac disease, or ameliorating their symptoms. When describing the present invention, all terms not defined herein have their common art-recognized meanings.

#The term “antibody” includes polyclonal and monoclonal antibodies. Avian yolk antibodies have been reported to exhibit useful properties for both research and clinical applications as mammalian antibodies do (see, for example, U.S. Pat. Nos. 5,340,923; 5,585,098; 5,601,823; and 5,976,519). Egg yolks derived from a laying hen are inexpensive and more convenient and safer to handle as compared to the hyperimmunized mammalian sera. More importantly, yolk antibodies are able to stand up to the scrutiny under modern animal protection regulations (A. Polson et al., Immunol. Commun. 9:475 (1980); and B. Gottstein et al.). These facts suggest a potential use of egg yolk as a commercial source of antibodies. Immunoglobulin Y (IgY) is an avian immunoglobulin.

#As used herein, the term “anti-gluten antibodies” refers to antibodies which specifically bind to at least one epitope in gluten, which may include gliadin, HMG or LMG. In one embodiment, anti-gluten antibodies comprises a cocktail of antibodies specific to different components of gluten.