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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

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: 12 Mar 2020

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At a glance

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

    • 12 Mar 2020 According to a Protalix Biotherapeutics media release, the company and its collaboration partner, Chiesi Farmaceutici S.p.A., or Chiesi, plan the submission of a BLA for PRX-102 via the FDA's Accelerated Approval pathway in the second quarter of 2020, based on data from the completed Phase I/II clinical trial of PRX-102 for the treatment of Fabry disease and the ongoing Phase III BRIDGE clinical trial.
    • 08 Aug 2019 According to a Protalix Biotherapeutics media release, results from this trial were published Journal of Inherited Metabolic Disease.
    • 10 May 2017 According to a Protalix Biotherapeutics media release, results from this trial were presented at the World Congress of Nephrology 2017, titled, The Fifth Update on Fabry Nephropathy.
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