Enolase 1 (ENO1) compositions and uses thereof
Inventors
Narain, Niven Rajin • Sarangarajan, Rangaprasad • VISHNUDAS, VIVEK K. • Gesta, Stephane • Jing, Enxuan
Assignees
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Publication Number
US-11224641-B2
Publication Date
2022-01-18
Expiration Date
Abstract
The invention provides compositions comprising Eno1 for delivery to a muscle. Further, the invention provides a method for normalizing blood glucose in a subject with elevated blood glucose, comprising administering to the subject enolase 1 (Eno1), thereby normalizing blood glucose in the subject. The invention also provides methods of treating one or more conditions including impaired glucose tolerance, insulin resistance, pre-diabetes, and diabetes, especially type 2 diabetes in a subject, comprising administering to the subject enolase 1 (Eno1), thereby treating the condition in the subject. In certain methods of the invention, the Eno1 is delivered to muscle.
Core Innovation
The invention concerns enolase 1 (Eno1) and compositions and complexes that include an Eno1 polypeptide or a fragment thereof. The invention provides a pharmaceutical composition comprising a therapeutically effective amount of an Eno1 polypeptide or fragment, together with a muscle targeting moiety, wherein the muscle targeting moiety and the Eno1 polypeptide or fragment are in a complex.
The described complexes are directed to muscle delivery, including skeletal muscle targeting. The disclosure further describes optional formulation forms and delivery components, including microparticles, nanoparticles, liposomes, in situ forming compositions, and dendrimer-based targeted complexes.
The invention also measures enolase 1 (Eno1) gene expression by detecting Eno1 nucleic acids from cDNA/cRNA microarrays using hybridization probes and nucleic-acid detection workflows. Eno1 nucleic acids are detected and quantified using PCR and multiple amplification alternatives, including reverse transcriptase PCR, and the detection context links Eno1 signal to clinical states based on identifying subjects with abnormal blood glucose and comparing results to reference groups.
The invention also measures Eno1 and related indicator biomolecules at the protein level, including immunodetection methods such as ELISA and other immunodetection formats, and optionally detects additional indicators including HbA1c. Quantitative detection is described using mass spectrometry workflows, including LC-MS/MS and MRM, together with stable-isotope labeling and internal standards for quantification.
Claims Coverage
The independent claim coverage centers on 3 inventive features: a pharmaceutical composition with an Eno1 polypeptide or fragment complexed with a muscle targeting moiety, a skeletal muscle targeting moiety, and optional formulation components.
Eno1 complexed with a muscle targeting moiety in a pharmaceutical composition
A pharmaceutical composition comprising a therapeutically effective amount of an enolase 1 (Eno1) polypeptide or a fragment thereof and a muscle targeting moiety, wherein the muscle targeting moiety and the Eno1 polypeptide or fragment are in a complex.
Skeletal muscle targeting moiety
The muscle targeting moiety is characterized as a skeletal muscle targeting moiety.
Optional microparticle, nanoparticle, in situ forming composition, or liposome
The pharmaceutical composition further comprises an additional component chosen from a microparticle, a nanoparticle, an in situ forming composition, or a liposome.
The inventive coverage centers on a therapeutically effective amount of an Eno1 polypeptide or fragment complexed with a muscle targeting moiety, with skeletal muscle targeting and optional formulation components including microparticles, nanoparticles, in situ forming compositions, or liposomes.
Stated Advantages
Decreases a subject’s blood glucose.
Treats diabetes.
Provides diagnostic and monitoring concepts using detection of Eno1 in biological samples.
Documented Applications
Pharmaceutical compositions and therapeutic methods for decreasing blood glucose in a subject having elevated blood glucose.
Treatment of diabetes, including pre-diabetes and impaired glucose tolerance context as described, with specific references to type 2 diabetes and type 1 diabetes.
Diagnostic and monitoring use cases for detecting Eno1 in biological samples, including immunoassays and nucleic-acid approaches for Eno1 mRNA, with kit/panel concepts combining Eno1 with HbA1c and glucose indicators.
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