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Publication Number
US-10548945-B2
Publication Date
2020-02-04
Expiration Date
Abstract
The invention relates to a topical composition containing a variant of an OB-fold protein, and also to the process for preparing the same.
Core Innovation
The invention provides topical, cosmetic, and therapeutic compositions comprising OB-fold protein variants, described as nanofitins. The variants are defined by mutating residues at the interface of binding of a wild-type OB-fold protein to its natural ligand, with between 5 and 20 mutated residues in that interface. The wild-type OB-fold proteins are selected from Sac7d or Sac7e derived from Sulfolobus acidocaldarius, Sso7d derived from Sulfolobus solfataricus, DBP 7 derived from Sulfolobus tokodaii, Ssh7b or Ssh7a derived from Sulfolobus shibatae, and p7ss derived from Sulfolobus solfataricus.
The compositions are formulated for skin or ocular use and include pharmaceutically and cosmetically acceptable excipients, with example formulation options including topical dermatological delivery formats and ocular compositions. The compositions optionally include co-actives. The nanofitin variants are characterized as passing through skin and/or ocular barriers when topically applied, and the document emphasizes that the variants retain target-neutralizing activity independently of the screening target.
Experimental evidence is used to support penetration and retained activity, including diffusion through human skin using a Franz cell diffusion test and permeability assessment using a rabbit cornea model. An in vivo psoriasis-like mouse model is also described, including PASI reduction using a comparison such as clobetazole/clobetasol controls. The disclosure links the defined binding-interface mutations and the topical delivery compositions to barrier penetration outcomes while maintaining neutralizing activity.
Claims Coverage
The partial content identifies two independent claims. Both claims center on topical application of a dermatological composition containing a specific OB-fold protein variant that passes through skin, with the variant defined by a binding-interface mutation count between 5 and 20 mutated residues.
Topical administration of OB-fold variants through skin
Topically applying a dermatological composition comprising a variant of a wild-type OB-fold protein on skin of a patient, wherein the variant passes through the skin of the patient.
Binding-interface mutational range for natural-ligand binding interface variants
Using a variant that has between 5 and 20 mutated residues in the interface of binding of the wild-type OB-fold protein to its natural ligand, where the wild-type OB-fold protein is selected from Sac7d or Sac7e, Sso7d, DBP 7, Ssh7b or Ssh7a, and p7ss, and where the mutated residues are selected from a defined set of Sac7d residue positions.
Across the independent claims, the inventive coverage is grounded in topical application of OB-fold nanofitin variants in a dermatological composition such that the variant passes through patient skin, and in defining the variant by the number of mutated residues at the wild-type OB-fold natural-ligand binding interface, with the wild-type OB-fold source restricted to the listed proteins.
Stated Advantages
Enables the variant to penetrate through the skin of a patient after topical application.
The variants retain target-neutralizing activity independent of the screening target.
Supports ocular barrier permeability as documented in the disclosure.
Documented Applications
Topical dermatological administration in which the variant passes through patient skin.
Ocular use compositions, with documented permeability in a rabbit cornea model.
Treatment evaluation in a psoriasis-like mouse model, including PASI reduction using clobetazole/clobetasol comparison.
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