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Publication Number
US-10214562-B2
Publication Date
2019-02-26
Expiration Date
Abstract
We describe peptides and their uses for the treatment of autoimmune, inflammatory and metabolic diseases.
Core Innovation
The invention features short Serpin-derived peptides, including alpha-1-antitrypsin-derived peptide SP16, as anti-inflammatory and immune-modulating agents for inflammatory, autoimmune, and metabolic diseases. It discloses methods of improving glycemic control in a subject having hyperglycemia by administering an oral formulation comprising a specified peptide family or specified peptide. The claims define the peptide as 21 or fewer amino acids long, alone or combined with an epitope tag or half-life extender.
Reported biological activities include concentration-dependent TLR2 activation, enhanced beta-cell function, reduced non-fasted blood glucose and HbA1c, increased C-peptide, and improved glucose tolerance in db/db mice. The supplied content also reports delayed and reduced type I diabetes incidence with higher proportions of subjects remaining diabetes-free in NOD mice. Furthermore, oral SP16 reduces inflammatory measures and arthritis scores in a mouse arthritis model.
Claims Coverage
The claims include two independent claims comprising two inventive features directed to administering an oral formulation to improve glycemic control in a subject having hyperglycemia.
Oral formulation comprising a peptide from a specified sequence family
A claim covers administering an oral formulation comprising a peptide from a specified sequence family or defined sequence alternatives, with the peptide limited to 21 or fewer amino acids, to improve glycemic control in a subject having hyperglycemia.
Oral formulation comprising the specified peptide alone or combined
A claim covers administering an oral formulation comprising the specified peptide, alone or combined with at least one second peptide or protein that is an epitope tag, a half-life extender, or both, to improve glycemic control in a subject having hyperglycemia.
Together, the independent claims cover oral administration of sequence-defined peptides or specified peptides, optionally combined with an epitope tag or half-life extender, for improving glycemic control in subjects having hyperglycemia.
Stated Advantages
The peptide improves glycemic control, reducing non-fasted blood glucose and HbA1c, increasing C-peptide, and improving glucose tolerance in db/db mice.
The peptide delays and reduces type I diabetes incidence, with about 90% of SP16-treated mice remaining diabetes-free through the study.
The peptide reduces inflammatory markers and clinical scores in a mouse arthritis model, including reduced IL-1̂̄ secretion.
A dependent claim recites that the peptide causes a 75% decrease in serum TNF-̂̄ levels when administered in an effective amount to a human subject.
Documented Applications
Improving glycemic control in a subject having hyperglycemia using an oral formulation comprising a specified peptide, as recited in the independent claims.
Treatment of inflammatory, autoimmune, and metabolic diseases, supported by glycemic control in db/db mice and delayed type I diabetes in NOD mice.
Protection in a mouse arthritis model via oral-gavage administration of SP16.
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