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

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
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