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US 2023/0414783 A1Published application
Biliary Delivery Methods, Compositions and Kits for Use Therein
AssigneeAmbys Medicines, Inc.
InventorsWhitney Krey, Garrett Heffner
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AssigneeAmbys Medicines, Inc.
InventorsWhitney Krey, Garrett Heffner
Estimating the term…
The present disclosure provides composition and methods for delivery of therapeutic biologics to locations where bile is present, including the biliary tract, and compositions and kits for use in such methods. Also provided are compositions that include, and methods that employ, biliary-therapeutic enhancers for the delivery of therapeutic biologics. Methods of biliary tract delivery of a therapeutic biologic, as described herein, generally include one or more administrations of the relevant biologic and biliary-therapeutic enhancer Biliary delivery compositions will generally include one or more biliary-therapeutic enhancers and a therapeutic biologic. As compared to the decreased activity of the therapeutic biologic in the presence of bile, the compositions, methods, and kits of the present disclosure result in increased, enhanced and/or rescued activity of the therapeutic in the presence of bile. Use of biliary-therapeutic enhancers, e.g., in the methods, compositions and kits described, are also provided.
A method of treating a subject for a condition, the method comprising:
The method of any of the preceding claims, wherein the administering comprises retroductal delivery of the therapeutic biologic to the liver of the subject thereby resulting in an increase in local hepatic concentration of the therapeutic biologic.
The method of any of the preceding claims, wherein the therapeutic biologic comprises a gene therapy agent or a protein.
The method of any of the preceding claims, wherein the biliary-therapeutic enhancer comprises one or more bile acid sequestrants.
The method of any of the preceding claims, wherein the biliary-therapeutic enhancer comprises a cationic or nonionic amphiphilic transduction enhancer.
The method of any of the preceding claims, wherein the therapeutic biologic and the biliary-therapeutic enhancer are co-administered, optionally wherein the therapeutic biologic and the biliary-therapeutic enhancer are co-formulated in a single pharmaceutical composition.
The method of any of the preceding claims, wherein the biliary-therapeutic enhancer is administered before the therapeutic biologic.
A pharmaceutical composition comprising:
A kit comprising:
Dependencies are inferred from the claim text.