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Details:
PRX-102 (pegunigalsidase alfa), EC authorized, is a novel PEGylated, covalently crosslinked form of α-galactosidase-A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2023
Details:
PRX–102 (pegunigalsidase alfa) a novel PEGylated, covalently crosslinked form of α-galactosidase A developed as enzyme replacement therapy for fabry disease, was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX–102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Protalix BioTherapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. It is a novel, PEGylated ERT under development for the treatment of Fabry disease.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Chiesi Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2022
Details:
PRX–102 (pegunigalsidase alfa) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX–102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Chiesi Global Rare Diseases
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
Results from the clinical development programme developed with Protalix BioTherapeutics evaluating pegunigalsidase alfa (PRX-102) an investigational enzyme replacement therapy (ERT), support its potential as a treatment option for adult patients with Fabry disease.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Protalix BioTherapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2022
Details:
Pegunigalsidase alfa (PRX–102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant α–Galactosidase–A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Chiesi Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2021
Details:
PRX–102 is currently being studied in the pivotal Phase III BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX–102 for the proposed treatment of Fabry disease.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2021
Details:
Following the switch to pegunigalsidase alfa there was a decrease in patients with progressing or fast progressing kidney disease, and the majority of patients achieved a stable status post-switch.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX–102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2021
Details:
Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
The BRIGHT study is a phase III, open label, switch over study to assess the safety, efficacy and pharmacokinetics of pegunigalsidase alfa 2 mg/kg administered by intravenous infusion in patients with Fabry disease currently treated with enzyme replacement therapy (ERT).
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: PRX-102
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Chiesi Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
The BLA has been filed for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway. Pegunigalsidase alfa a long-acting recombinant, PEGylated, cross-linked α-galactosidase-A product.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
The BRIDGE study was a Phase III study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2020
Details:
Financing will advance the Company's clinical programs and commercialization of PRX-102 for the treatment of Fabry disease, as well as to further develop its early stage pipeline of therapeutics.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Psagot Investment House
Deal Size: $43.7 million Upfront Cash: Undisclosed
Deal Type: Financing March 12, 2020
Details:
Phase I/II dose-ranging studies show high correlation between two Fabry disease biomarkers, supporting potential effectiveness of pegunigalsidase alfa in treating Fabry disease.
Lead Product(s): Pegunigalsidase alfa
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2020
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