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Protalix's PRX–102 Monthly Treatment Shows Benefit In Fabry Disease

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  • Protalix BioTherapeutics Inc (NYSE: PLX) and its collaborating partner Chiesi Farmaceutici S.p.A. announced positive topline results from the BRIGHT Phase 3 trial evaluating pegunigalsidase alfa (PRX–102) for the potential treatment of Fabry disease.
  • It is a genetic disorder in which the body cannot make an enzyme called alpha-galactosidase A, which is essential to breaking down globotriaosylceramide (Gb3 or GL-3), a type of fat that cells can use as building blocks.
  • PRX–102 is a plant cell-expressed recombinant, PEGylated, cross-linked α–galactosidase–A product candidate that is, administered every four weeks.
  • Results indicated that intravenous infusion of PRX–102 was well-tolerated, and stable clinical presentation was maintained. 
  • No new patients developed treatment-induced anti-drug antibodies following the switch to PRX–102 treatment.
  • Study outcome measures showed plasma lyso–Gb3 concentrations remained stable during the study with a mean change of 3.01 nM from baseline to Week 52.
  • Mean absolute change of eGFR values were stable during the 52–week treatment period, with a mean change from baseline of –1.27 mL/min/1.73 m2.
  • The company will report final data from the study in the second half of 2021
  • Price Action: PLX increased 7.2% at $5.54 in premarket trading on the last check Tuesday.
 

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Posted-In: Fabry diseaseBiotech News FDA General

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