Patent Application Titled “Methods For Preventing Or Mitigating Acute Allergic Responses Using Human Milk Oligosaccharides” Published Online (USPTO 20200206251)

2020 JUL 20 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the inventors BUCK, RACHAEL (Gahanna, OH); DAVIS, STEVEN (Galena, OH); FORSYTHE, PAUL (Hamilton, CA), filed on December 30, 2019, was made available online on July 2, 2020.

The assignee for this patent application is Abbott Laboratories (Abbott Park, Illinois, United States).

Reporters obtained the following quote from the background information supplied by the inventors: “The maintenance of a balanced immune system is important to human health. On the one hand, reduced immunity can leave an individual vulnerable to attack from foreign microorganisms. On the other, individuals with hyper-active immune systems can suffer from mild to severe allergies. Common allergic symptoms include sneezing, asthma, diarrhea, skin itching, hives, and angioedema. In rare cases, allergies can result in severe or deadly symptoms such as anaphylactic shock. While allergies can be a mild irritant, they can also have a significant impact on an individual’s daily activities and quality of life. Although allergies typically develop during childhood, allergies may develop at any time during an individual’s lifespan.

“A limited number of treatments exist to address the problem of allergies. In some patient populations, certain allergies can be treated with pharmaceuticals, including antihistamines and eicosanoid inhibitors. Despite available treatment options, the prevalence of allergies in the global population is increasing, such that allergies are now considered an epidemic by The World Health Organization.

“There are likely several reasons for the increase in allergies among global populations. First, available treatment options are often inappropriate for all populations. For example, due to potential side effects, pharmaceuticals may be inappropriate for children and infants, a population in which allergies are highly prevalent and ever-increasing. Second, available treatment options do not address all types of allergies. For example, food allergies, in particular, have no effective drug therapy. As a result, avoidance of the triggering foods or antigens is often the only course of action for affected individuals. Third, available treatment options do not fully address the underlying causes of allergies. For example, the nervous system plays an important role in regulating immune responses associated with allergic inflammation as well as gastrointestinal symptoms associated with a food allergy. While antihistamines address the immune system’s role in an allergic response, they do not address the actions of the nervous system. Fourth, some treatment options may decrease natural defenses that help prevent allergic responses. For example, increasing antibiotic use in industrialized countries may disrupt normal microbiota-mediated mechanisms of immunological tolerance in the mucosa. This disruption of the natural microbiome can, in turn, lead to an increased susceptibility to immunological disorders including allergy.

“It would be desirable to provide additional treatment options to reduce the risk of allergy development, help in the management of allergic disease, or both. Such treatments may reduce the severity of symptoms, increase the antigen exposure levels required to trigger allergic responses, or both. To be useful across patient populations, it would be beneficial to provide a benign approach to allergy treatment. To treat various types of allergies, it would be useful for the treatment to be available as multiple formulations such as nutritionals, dietary supplements, or topical products. Where pharmaceuticals are useful, it would be helpful to provide new treatments that complement existing pharmaceutical approaches to allergy control. Where pharmaceuticals are inappropriate or ineffective, it is desirable to offer alternative approaches to allergic disease management. To support natural defenses to allergies, it would be helpful for the treatment options to promote the body’s natural microbiome, or to help reestablish it, or both.”

In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors’ summary information for this patent application: “Disclosed herein are methods for preventing or mitigating an acute allergic response in a subject. An acute allergic response is prevented or mitigated by administering human milk oligosaccharides (HMOs) to the subject.

“A method for preventing or mitigating an acute allergic response in a subject is disclosed. The method includes a step of administering a nutritional composition to the subject. The nutritional composition includes at least one of an acidic or a neutral HMO, but does not include an N-acetyl-lactosamine.

“The present invention provides a method for preventing or mitigating an acute allergic response in a subject, the method comprising administering a nutritional composition to the subject, wherein the nutritional composition comprises at least one human milk oligosaccharide (HMO) selected from the group consisting of acidic HMOs and neutral HMOs, and wherein the nutritional composition does not contain an N-acetyl-lactosamine.

“The present invention also provides a nutritional composition for use in the prevention, treatment and/or mitigation of an acute allergic response in a subject, wherein the nutritional composition comprises at least one human milk oligosaccharide (HMO) selected from the group consisting of acidic HMOs and neutral HMOs, and wherein the nutritional composition does not contain an N-acetyl-lactosamine.

“In the specification, references to the method also apply to the composition where applicable, and vice versa.

“Further areas of applicability of the present disclosure will become apparent from the detailed description, drawings, and claims provided hereinafter. It should be understood that the detailed description, including disclosed embodiments and drawings, are merely exemplary in nature, are only intended for purposes of illustration, and are not intended to limit the scope of the invention, its application, or use.”

The claims supplied by the inventors are:

“1. A method for reducing the severity of an allergic response in a subject in need thereof, the method comprising administering a nutritional composition to the subject, wherein the nutritional composition comprises a human milk oligosaccharide (HMO) component, the HMO component selected from the group consisting of fucosylated oligosaccharides, sialylated oligosaccharides, or a combination thereof.

“2. The method of claim 1, wherein the allergic response comprises one or more mast cell mediated immediate allergic response.

“3. The method of claim 2, wherein the HMO component consists of a neutral HMO which is 2’-fucosyllactose (2’-FL) and an acidic HMO which is 6’-sialyllactose (6’-SL), and the one or more mast cell mediated immediate allergic response is selected from the group consisting of a skin mast cell response, a gastrointestinal mast cell response, and a respiratory mast cell response.

“4. The method of claim 2, wherein the HMO component comprises either 2’-FL or 6’-SL, but not both.

“5. The method of claim 2, wherein the HMO component comprises 2’-FL, 6’-SL, or both, and the nutritional composition is administered to the subject to mitigate an allergic response comprising more than one mast cell mediated immediate allergic response.

“6. The method of claim 1, wherein the HMO component includes 2’-FL, 6’-SL, or both in an amount of 0.001 mg/mL to 20 mg/mL.

“7. The method of claim 4, wherein a nutritional composition comprising 2’-FL is administered to the subject to mitigate one mast cell mediated immediate allergic response.

“8. The method of claim 4, wherein a nutritional composition comprising either 2’-FL or 6’-SL SL is administered to the subject to mitigate a skin mast cell response.

“9. The method of claim 4, wherein a nutritional composition comprising 2’-FL is administered to the subject to mitigate a gastrointestinal mast cell response.

“10. The method of claim 5, wherein a nutritional composition comprising both 2’-FL and 6’-SL is administered to the subject to mitigate an acute allergic response.

“11. The method of claim 1, wherein the nutritional composition further comprises at least one of a protein source, a carbohydrate source, and a fat source.

“12. The method of claim 1, further comprising administering an antihistamine to the subject.

“13. The method of claim 12, wherein the antihistamine comprises a compound selected from the group consisting of loratadine, fexofenadine, and cetirizine.

“14. The method of claim 1, further comprising administering an eicosanoid inhibitor to the subject.

“15. The method of claim 1, wherein the nutritional composition further comprises a carbohydrate selected from the group consisting of maltodextrin, corn syrup solids, and sucrose.

“16. The method of claim 1, wherein the nutritional composition further comprises a hypoallergenic form of galacto-oligosaccharide.

“17. A method for mitigating an immediate type allergic response in a subject in need thereof, the method comprising administering a nutritional composition to the subject, wherein the nutritional composition comprises a human milk oligosaccharide (HMO) component, the HMO component selected from the group consisting of fucosylated oligosaccharides, sialylated oligosaccharides, or a combination thereof.

“18. The method of claim 18, wherein the fucosylated oligosaccharide is 2’-FL and the sialylated oligosaccharide is 6’-SL.

“19. The method of claim 19, wherein a nutritional composition comprising both 2’-FL and 6’-SL is administered to the subject to mitigate an acute allergic response.

“20. A method for reducing the severity of an allergic response in a subject in need thereof, the method comprising administering a nutritional composition to the subject, wherein the nutritional composition comprises a human milk oligosaccharide (HMO) component, the HMO component selected from the group consisting of 2’-FL, 6’-SL, or a combination thereof, wherein the human milk oligosaccharide is present in an amount effective to increase the antigen exposure levels required to trigger an allergic response.”

For more information, see this patent application: BUCK, RACHAEL; DAVIS, STEVEN; FORSYTHE, PAUL. Methods For Preventing Or Mitigating Acute Allergic Responses Using Human Milk Oligosaccharides. Filed December 30, 2019 and posted July 2, 2020. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200206251%22.PGNR.&OS=DN/20200206251&RS=DN/20200206251

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