Treatment of disease with poly-N-acetylglucosamine nanofibers
Inventors
Vournakis, John N. • Finkielsztein, Sergio
Assignees
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Publication Number
US-10765698-B2
Publication Date
2020-09-08
Expiration Date
Abstract
This application relates to compositions comprising shortened fibers of poly-N-acetylglucosamine and/or a derivative thereof (“sNAG nanofibers”) and the use of such compositions in the treatment of disease.
Core Innovation
The invention relates to shortened poly-N-acetylglucosamine fibers, or sNAG nanofibers, for treating and preventing diseases. The compositions comprise sNAG nanofibers as the only active ingredient and are characterized by a defined monosaccharide composition and a defined fiber length distribution.
The sNAG nanofibers comprise 70% or more N-acetylglucosamine monosaccharides, and more than 50% of the sNAG nanofibers are between 1 to 15 cmm in length. The material is further characterized by infrared spectrum equivalence to non-irradiated microalgal poly-N-acetylglucosamine and by determining fiber length using scanning electron microscopy analysis.
The invention describes production of the sNAG nanofibers by irradiating poly-N-acetylglucosamine fibers in dry or wet states. The disclosure further states that the sNAG nanofibers induce defensin and Toll-like receptor activity, with Akt1-dependent signaling and Ets1 discussed in relation to defensin induction, wound healing, and inflammatory bowel disease models.
Claims Coverage
The claim coverage includes three independent claims centered on topical administration of a composition whose only active ingredient is sNAG nanofibers. The inventive features combine topical treatment targets with quantitative compositional and length-distribution requirements for the sNAG nanofibers.
Topical treatment of atopic dermatitis with only sNAG nanofibers
A method for treating atopic dermatitis in a human subject by topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (sNAG nanofibers) to the skin of the human subject, where the sNAG nanofibers comprise 70% or more N-acetylglucosamine monosaccharides, more than 50% of the sNAG nanofibers are between 1 to 15 cmm in length, and the sNAG nanofibers are the only active ingredient in the composition.
Reduction of atopic dermatitis symptoms with only sNAG nanofibers
A method for reducing the severity or duration of one or more symptoms associated with atopic dermatitis in a human subject by topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (sNAG nanofibers) to the skin of the human subject, where the sNAG nanofibers comprise 70% or more N-acetylglucosamine monosaccharides, more than 50% of the sNAG nanofibers are between 1 to 15 cmm in length, and the sNAG nanofibers are the only active ingredient in the composition.
Topical treatment of inflammatory bowel disease with only sNAG nanofibers
A method for treating inflammatory bowel disease in a human subject by topically administering a composition comprising shortened poly-N-acetylglucosamine fibers (sNAG nanofibers) to the human subject, where the sNAG nanofibers comprise 70% or more N-acetylglucosamine monosaccharides, more than 50% of the sNAG nanofibers are between 1 to 15 cmm in length, and the sNAG nanofibers are the only active ingredient in the composition.
The claim scope is directed to treating atopic dermatitis and inflammatory bowel disease by topical administration, where the only active ingredient is sNAG nanofibers defined by a high N-acetylglucosamine monosaccharide fraction and a length distribution requiring that more than 50% of nanofibers fall within 1 to 15 cmm.
Stated Advantages
Increases defensin and Toll-like receptor activity.
Provides non-reactive/low-grade biocompatibility in implantation, elution, intracutaneous, and systemic tests, with limited irritation as described.
Described as non-bacterial direct growth effect.
Supports non-barrier topical formulations including gels, creams, ointments, membranes, dressings, and suppositories.
Reduces lesion numbers, severity, and duration of symptoms, including pain, for infectious conditions described in the disclosure.
Reduces recurrence and/or spread for some viral infection indications described in the disclosure.
Improves clinical outcomes and may reduce hospitalization for infectious conditions described in the disclosure.
Provides anti-fungal/anti-yeast activity linked to inducing beta defensins such as beta-defensin 1.
Promotes wound healing, including wound closure kinetics, linked to Akt1/Ets1-dependent defensin expression.
Shows defensin-dependent anti-bacterial activity in vivo against Staphylococcus aureus.
Includes preclinical biocompatibility/allergenicity testing and a human pilot study reporting reduced duration and pain for HSV cold sores.
Documented Applications
Treating atopic dermatitis in a human subject by topically administering sNAG nanofiber compositions to the skin.
Reducing the severity or duration of one or more symptoms associated with atopic dermatitis via topical administration of sNAG nanofiber compositions to the skin.
Treating inflammatory bowel disease in a human subject via topically administering sNAG nanofiber compositions.
Treating viral warts, including plantar warts and viral warts.
Treating viral infections in immunocompromised patients, including HIV.
Treating viral gastroenteritis, including rotavirus, norovirus, adenovirus, and astrovirus, including rectal administration.
Treating viral gastroenteritis involving protozoal and other organisms described in the document, including Giardia lamblia, Cryptosporidium, and Entamoeba histolytica.
Treating anti-fungal/anti-yeast conditions, including yeast infections and candidiasis, and other fungal indications described such as tinea versicolor, sporotrichosis, and osteomyelitis.
Treating skin and inflammatory conditions described in the document, including atopic dermatitis and psoriasis.
Supporting wound healing for wound healing outcomes described in the document, including wound infections.
Topical treatment use for HSV cold sores, as described in a human pilot study reporting reduced duration and pain.
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