Benzinga | Feb 23, 2021 08:04AM EST

Protalix's PRX102 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 ?--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.