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A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Months to Adult Fabry Patients

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Trial Profile

A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Months to Adult Fabry Patients

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 13 Feb 2024

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At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational
  • Sponsors Protalix Biotherapeutics

Most Recent Events

  • 08 Feb 2024 According to a Chiesi media release, the immunogenicity and tolerability data of this study have been presented during the 20th Annual WORLDSymposium™ Research Meeting that is being held February 4-9, 2024, in San Diego, California.
  • 24 Feb 2023 According to a Chiesi media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease, based on data from Phase 3 BALANCE, BRIDGE, and BRIGHT clinical trials, the Phase 1/2 clinical trial, and ongoing related extension studies. A final EC decision on the MAA is expected in the beginning of May 2023.
  • 09 Nov 2022 According to a Protalix BioTherapeutics media release, company has resubmitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease.

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