US-12622940-B2 - Combined fungal composition for modulating an inflammatory response

Abstract

Described herein are combined fungal compositions for treating, prophylaxis of, or ameliorating symptoms of one or more adverse reactions triggered by an infectious disease or condition that causes an inflammatory response. In one aspect the composition comprises an aqueous or solid fraction of Trametes versicolor and Fomitopsis officinalis mycelium, fermented substrates thereof, or combinations thereof.

Inventors

• Paul E. STAMETS

Assignees

• TURTLE BEAR HOLDINGS, LLC

Dates

Publication Date

20260512

Application Date

20230808

Claims (19)

1. 1 . A method for treating, prophylaxis of, or ameliorating symptoms of an infectious disease in a subject in need thereof comprising: administering to the subject a therapeutically effective amount of a composition comprising: 200-1,800 mg of an aqueous or solid fraction of Trametes versicolor mycelium, a fermented substrate thereof, or a combination thereof; and 200-1,800 mg of an aqueous or solid fraction of Fomitopsis officinalis mycelium, a fermented substrate thereof, or a combination thereof.
2. 2 . The method of claim 1 , wherein the aqueous or solid fraction comprises beta-glucans.
3. 3 . The method of claim 1 , wherein the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients.
4. 4 . The method of claim 1 , wherein the infectious disease comprises one or more symptoms comprising shortness of breath, wheezing, coughing, yellow mucus, green mucus, blood-tinged mucus, chest pain, breathlessness, rapid breathing, hypoxia, inflammation of the lung tissue, rapid heart rate, or increased blood pressure, or decreased blood pressure.
5. 5 . The method of claim 1 , wherein the infectious disease comprises a bacterial infection.
6. 6 . The method of claim 5 , wherein the bacterial infection comprises one or more of Streptococcus pneumoniae, Mycobacterium tuberculosis, Bordetella pertussis, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Stenotrophomonas maltophila, Staphylococcus aureus, Streptococcus pyogenes, Neisseria meningitidis, Klebsiella pneumoniae , or Non-tuberculosis Mycobacterium.
7. 7 . The method of claim 1 , wherein the infectious disease comprises a viral infection.
8. 8 . The method of claim 7 , wherein the viral infection comprises one or more of Paramyxoviridae (respiratory syncytial virus (RSV), parainfluenza virus (PIV), metapneumovirus (MPV), enteroviruses), Picornaviridae (Rhinovirus, RV), Coronaviridae (CoV), Adenoviridae (Adenovirus), Parvoviridae (HBOV), Orthomyxoviridae (influenza A, B, C, D, Isavirus, Thogotovirus, Quaranjavirus), or Herpesviridae (human herpes viruses, Varicella zoster virus, Epstein-Barr virus, cytomegalovirus).
9. 9 . The method of claim 8 , wherein the CoV comprises one or more of Severe Acute Respiratory Syndrome (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV), COVID-19 (2019-nCoV, SARS-CoV-2), 229E, NL63, OC43, or HKU1.
10. 10 . The method of claim 1 , wherein the symptoms of an infectious disease comprise an inflammatory response associated with a bacterial or viral infection.
11. 11 . The method of claim 1 , wherein the administration modulates one or more of cytokine storms, neuroinflammation, or blood clotting.
12. 12 . The method of claim 1 , wherein a dose of the composition is administered to the subject 3 times per day.
13. 13 . The method of claim 1 , wherein the composition is in the form of a capsule.
14. 14 . The method of claim 13 , wherein the dose comprises at least 4 capsules.
15. 15 . The method of claim 1 , wherein the composition is administered to the subject for about 10 to 30 consecutive days.
16. 16 . The method of claim 1 , wherein the composition is administered to the subject for about 14 days.
17. 17 . The method of claim 1 , wherein the subject has COPD, Cardiovascular disease, diabetes mellitus, hypertension, or a combination thereof.
18. 18 . The method of claim 1 , wherein the subject is at least 60 years old.
19. 19 . The method of claim 1 , wherein the composition is administered orally.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a divisional of U.S. patent application Ser. No. 17/221,411, filed Apr. 2, 2021, which claims priority to U.S. Provisional Patent Application No. 63/004,788, filed on Apr. 3, 2020 and U.S. Provisional Patent Application No. 63/029,815, filed on May 26, 2020, each of which are incorporated by reference herein in its entirety. TECHNICAL FIELD Described herein are mushroom compositions and methods for treating, prophylaxis of, or ameliorating symptoms of one or more adverse reactions triggered by an infectious disease or condition that increases an anti-inflammatory response in a subject with such compositions. In one aspect the composition comprises an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof optionally combined with one or more buffering agents, ethanol, and water. BACKGROUND Mushrooms have been embraced for centuries due to their nutritional and medicinal properties. They have been historically used in the treatment of infectious disease, gastrointestinal disorders and asthmatic conditions, as well as to support overall wellbeing. Fungi now occupy their own kingdom, but they were once considered plants due to their resemblance and root-like structures. One of many characteristics that separate fungal from plant organisms is the cell wall structure. The cell walls of fungi contain chitin, a modified form of the polysaccharide cellulose. Chitin is comprised of β-(1→4)-linked N-acetylglucosamine monomers, whereas cellulose is comprised of β-(1→4)-linked glucose units. Chitin degrades into a mixture of shorter-chained polysaccharides along with monosaccharide products. This degradation can occur with a variety of processing techniques that implement heat and drying. Contemporary research has mainly focused on the broad immune activity of mushrooms. Mushroom polysaccharides possess documented immunomodulatory properties, specifically through the activation of natural killer cells, macrophages, and neutrophils, as well as induction of innate immune cytokines and interleukins. β-glucans, proteoglycans, and heteroglucans are classes of polymers present in the cell walls of fungi. The generic term β-glucan refers to the polymeric form of glucose residues connected by β-(1→3), β-(1→4), and β-(1→6)-linkages. The type of β-glucans isolated from fungi consist mainly of a linear backbone of β-(1→3) glucose monomers and side branches comprised of β-(1→3) and β-(1→6)-linked oligosaccharides. The most widely studied β-glucans are comprised of (1→3)-β, and (1,6)-β linkages, which exhibit immunostimulatory and antitumor properties. These polysaccharides are ligands for the dectin-1 and toll-like receptor 2 (TLR-2) receptor systems expressed on macrophages and dendritic cells, inducing NK cells, neutrophils, T-cells, B-cells, as well as TNF-a, IL-4, and IL-6 signaling. The Complement Receptor-3 (CD11b/CD18) in context of extracellular matrix is also involved in immune responses to fungal β-glucans. While the immune activating, pro-inflammatory properties of fungal water-insoluble β-glucans are well documented, the immune modulating effects of fungal non-β-glucan-fractions are less recognized. While prior research on medicinal mushrooms has primarily focused on the solid, β-glucan-rich fraction, and β-glucan mediated responses are clearly important, focusing on this compound class in isolation clearly does not reflect the overall bioactivity of a complex blend when consumed for immune support. Emerging evidence suggests that a blend of mushrooms may provide additive or synergistic effects on the host immune response. SUMMARY One embodiment described herein is a composition for treating, prophylaxis of, or ameliorating symptoms of one or more adverse reactions triggered by an infectious disease or condition that increases an anti-inflammatory response in a subject, the composition comprising: an aqueous or solid fraction of a mushroom mycelium and/or fruit body mixture; one or more buffering agents; ethanol; and water. In one aspect, the aqueous or solid fraction comprises beta-glucans. In another aspect, the buffering agent comprises phosphate buffered saline. In another aspect, the composition comprises an aqueous or solid fraction of Trametes versicolor mycelium. In another aspect, the composition comprises about 200 mg to about 10 g of Trametes versicolor mycelium. In another aspect, the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients. In another aspect, the infectious disease or condition increases expression of growth factors. In another aspect, the growth factors comprise one or more of basic fibroblast growth factor, or vascular endothelial growth factor. In another aspect, the mushroom mycelium and/or fruit body mixture comprises one or more of Agaricus brasiliensis f. blazei, Cordyceps militaris, Flam