FORMULATIONS COMPRISING GLUCOCEREBROSIDASE AND ISOPHAGOMINE

AR113797B1Active Publication Date: 2026-08-28TAKEDA PHARMA CO LTD
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Patent Information

Application Number
ARP20180103113
Authority / Receiving Office
AR · AR
Patent Type
Patents
Current Assignee / Owner
Priority Date
2017-10-26
Filing Date
2018-10-25
Publication Date
2026-08-28
Estimated Expiration
2038-10-25

AI Technical Summary

Technical Problem

Current formulations of glucocerebrosidase (GCB) such as velaglucerase alfa suffer from physical and chemical instabilities, leading to reduced stability and bioavailability, especially when administered subcutaneously, which limits their effectiveness in treating Gaucher disease.

Method used

A composition comprising glucocerebrosidase (GCB) and isofagomine (IFG), particularly isofagomine tartrate (IFGT), in specific molar ratios, is developed to enhance stability and bioavailability, allowing for subcutaneous administration with improved serum exposure.

Benefits of technology

The GCB/IFGT composition achieves enhanced stability and bioavailability, providing serum exposure comparable to intravenous administration, reducing the frequency of injections and maintaining therapeutic efficacy.

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Abstract

This product provides a glucocerebrosidase composition, such as velaglucerase and isophagomin, in a molar ratio of at least approximately 1:2.5. It is also provided for the treatment of a disorder related to dysfunction in a GCa-2 pathway. The disorder could be a lysosomal storage disease, such as Gaucher disease, Fabry disease, Pompe disease, mucopolysaccharidosis, or multiple system atrophy. The disorder could also be a neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia. The composition may contain from 0.5 to 5.0 mg / kg of glucocerebrosidase and isophagomin in a molar excess of at least approximately 3 with respect to glucocerebrosidase. The composition may be administered intravenously or subcutaneously.
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