IP Library Patent Application 19644684
Patent Application
App. No. 19/644,684

COMPOSITIONS AND METHODS FOR MODULATING INFLAMMATORY RESPONSE

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Patent No.
US None
App. No.
19/644,684
Abstract

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.

Claims (105)

1 . 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 mycelium, a fermented substrate thereof, or a combination thereof;

one or more buffering agents;

ethanol; and

water.

2 . The composition of claim 1 , wherein the mycelium comprises one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

3 . The composition of claim 1 , wherein the mycelium is Fomitopsis officinalis mycelium.

4 . The composition of claim 1 , wherein the aqueous or solid fraction comprises beta-glucans.

5 . The composition of claim 1 , wherein the buffering agent comprises phosphate buffered saline.

6 . The composition of claim 1 , wherein the composition comprises about 200 mg to about 10 g of Trametes versicolor, Hericium erinaceus , or Inonotus obliquus mycelium.

7 . The composition of claim 1 , wherein the composition comprises about 200 mg to about 10 g of Fomitopsis officinalis mycelium.

8 . The composition of claim 1 , wherein the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients.

9 . The composition of claim 1 , wherein the infectious disease or condition increases expression of growth factors.

10 . The composition of claim 9 , wherein the growth factors comprise one or more of basic fibroblast growth factor or vascular endothelial growth factor.

11 . 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 Fomitopsis officinalis mycelium, a fermented substrate thereof, or a combination thereof;

one or more buffering agents;

ethanol; and

water.

12 . The composition of claim 11 , wherein the aqueous or solid fraction comprises beta-glucans.

13 . The composition of claim 11 , wherein the buffering agent comprises phosphate buffered saline.

14 . The composition of claim 11 , wherein the infectious disease or condition increases expression of growth factors.

15 . The composition of claim 14 , wherein the growth factors comprise one or more of basic fibroblast growth factor or vascular endothelial growth factor.

16 . The composition of claim 11 , wherein the composition comprises about 200 mg to about 10 g of Fomitopsis officinalis mycelium.

17 . The composition of claim 11 , wherein the infectious disease comprises a bacterial infection.

18 . The composition of claim 17 , 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.

19 . The composition of claim 11 , wherein the infectious disease comprises a viral infection.

20 . The composition of claim 19 , 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).

21 . The composition of claim 20 , 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.

22 . A composition comprising an aqueous or ethanolic extract of Fomitopsis officinalis mycelium.

23 . Use of the composition of any one of the preceding claims for modulating an inflammatory response comprising administering an effective amount of the composition to a subject in need thereof.

24 . The use of claim 23 , wherein the inflammatory response comprises release of anti-inflammatory and pro-inflammatory cytokines.

25 . The use of claim 24 , wherein the pro-inflammatory cytokines comprise one or more of interleukin-1β, interleukin-2, interleukin-4, interleukin-5, interleukin-6, interleukin-7, interleukin-8, interleukin-9, interleukin-12p70, interleukin-13, interleukin-15, interleukin-17A, tumor necrosis factor-α, interferon-γ, monocyte chemoattractant protein 1, eotaxin, interferon gamma-induced protein 10, granulocyte colony-stimulating factor, macrophage inflammatory protein 1α, macrophage inflammatory protein 1β, or RANTES.

26 . The use of claim 24 , wherein the anti-inflammatory cytokines comprise one or more of interleukin-1 receptor antagonist, interleukin-2, interleukin-4, interleukin-7, interleukin-9, interleukin-10, or interleukin-15.

27 . A means for modulating an inflammatory response comprising administering to a subject in need thereof an effective amount of the composition of any one of the preceding claims .

28 . The means of claim 27 , wherein the inflammatory response comprises release of anti-inflammatory and pro-inflammatory cytokines.

29 . A method for treating, prophylaxis of, or ameliorating symptoms of an infectious disease comprising:

administering to a subject in need thereof an effective amount of a composition comprising:

an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof;

one or more buffering agents;

ethanol; and

water.

30 . The method of claim 29 , wherein the mycelium comprises one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

31 . The method of claim 29 , wherein the mycelium is Fomitopsis officinalis mycelium.

32 . The composition of claim 29 , wherein the composition comprises about 200 mg to about 10 g of Trametes versicolor, Hericium erinaceus , or Inonotus obliquus mycelium.

33 . The composition of claim 29 , wherein the composition comprises about 200 mg to about 10 g of Fomitopsis officinalis mycelium.

34 . The method of claim 29 , wherein the aqueous or solid fraction comprises beta-glucans.

35 . The method of claim 29 , wherein a dose of the composition is administered to the subject 3 times per day.

36 . The method of claim 29 , wherein the composition is in the form of a capsule.

37 . The method of claim 35 , wherein the dose comprises at least 4 capsules.

38 . The method of claim 29 , wherein the composition is administered to the subject for about 10 to 30 consecutive days.

39 . The method of claim 29 , wherein the composition is administered to the subject for about 14 days.

40 . The method of claim 29 , wherein the subject has COPD, Cardiovascular disease, diabetes mellitus, hypertension, or a combination thereof.

41 . The method of claim 29 , wherein the subject is at least 60 years old.

42 . The method of claim 29 , wherein the composition is administered orally.

43 . The method of claim 29 , wherein the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients.

44 . The method of claim 29 , 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.

45 . The method of claim 29 , wherein the infectious disease comprises a bacterial infection.

46 . The method of claim 45 , 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.

47 . The method of claim 29 , wherein the infectious disease comprises a viral infection.

48 . The method of claim 47 , 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).

49 . The method of claim 48 , 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.

50 . A method for treating, prophylaxis of, or ameliorating symptoms of a bacterial or viral infection comprising administering an effective amount of an aqueous or solid extract of one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

51 . A method for modulating an inflammatory response associated with a bacterial or viral infection comprising administering an effective amount of an aqueous or solid extract of one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

52 . The method of claim 51 , wherein the administration modulates one or more of cytokine storms, neuroinflammation, or blood clotting.

53 . A method of manufacturing the composition of any one of the preceding claims , the method comprising:

growing a mushroom on a substrate; and,

separating the mushroom mycelium from a fruitbody and the substrate.

54 . The method of claim 53 , wherein the method further comprises incubating the mycelium with a solvent, forming a solution; extracting an aqueous fraction from the solution; and

extracting a solid fraction from the solution.

55 . The method of claim 53 , wherein the method further comprises freeze-drying the mycelium; and grinding the dried mycelium into a powder.

56 . The method of claim 55 , wherein a pressure of about 1,500 mbar to about 2,000 mbar is applied to the mycelium during freeze-drying.

57 . The method of any one of claims 53-56 , wherein a temperature of about 75° C. to 95° C. is applied to the mycelium.

58 . The method of any one of claims 53-57 , wherein the substrate comprises one or more of rice, oat, straw, or sawdust.

59 . The method of any one of claims 53-57 wherein the mushroom is grown on a substrate at about 15° C. to about 30° C. for about 20 to about 120 days.

60 . The method of any one of claims 53-57 , wherein the mushroom is grown on a substrate at about 20° C. to about 25° C. for about 40 days.

61 . The method of any one of claims 53-57 , wherein the solvent is cold water.

62 . A method for treating or lessening the severity of any type of pain in a subject in need thereof comprising:

administering to the subject an effective amount of a composition comprising:

an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof;

one or more buffering agents;

ethanol; and

water.

63 . The method of claim 62 , wherein the mycelium comprises one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

64 . The method of claim 62 , wherein the mycelium is Fomitopsis officinalis mycelium.

65 . The method of claim 62 , wherein the composition comprises about 200 mg to about 10 g of Trametes versicolor, Hericium erinaceus , or Inonotus obliquus mycelium.

66 . The method of claim 62 , wherein the composition comprises about 200 mg to about 10 g of Fomitopsis officinalis mycelium.

67 . The method of claim 62 , wherein the aqueous or solid fraction comprises beta-glucans.

68 . The method of claim 62 , wherein a dose of the composition is administered to the subject 3 times per day.

69 . The method of claim 62 , wherein the composition is in the form of a capsule.

70 . The method of claim 68 , wherein the dose comprises at least 4 capsules.

71 . The method of claim 68 , wherein the composition is administered orally.

72 . The method of claim 62 , wherein the composition further comprises one or more preservatives, flavorings, colorings, stabilizers, emulsifiers, or other pharmaceutically acceptable excipients.

73 . The method of claim 62 , wherein the pain comprises one or more types of neuropathic pain, somatic pain, visceral pain, and other types of pain.

74 . A method for enhancing a viral therapy comprising:

administering to a subject an effective amount of a composition comprising:

an aqueous or solid fraction of a mycelium, a fermented substrate thereof, or a combination thereof;

one or more buffering agents;

ethanol; and

water.

75 . The method of claim 74 , wherein the viral therapy comprises a vaccine, an antiviral drug, or a combination thereof.

76 . The method of claim 74 , wherein the mycelium comprises one or more of Fomitopsis officinalis, Trametes versicolor, Hericium erinaceus , or Inonotus obliquus.

77 . The method of claim 74 , wherein the mycelium is Fomitopsis officinalis mycelium.

78 . The method of claim 74 , wherein the composition comprises about 200 mg to about 10 g of Trametes versicolor, Hericium erinaceus , or Inonotus obliquus mycelium.

79 . The method of claim 74 , wherein the composition comprises about 200 mg to about 10 g of Fomitopsis officinalis mycelium.