PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Protalix Bio up 6% on positive PRX–102 data in Fabry disease

7:36 AM EST
Via Seeking Alpha

Protalix BioTherapeutics (NYSEMKT:PLX) and Chiesi Farmaceutici S.p.A., have announced positive topline results from the BRIGHT Phase III trial evaluating pegunigalsidase alfa (PRX–102), 2 mg/kg, for the potential treatment of Fabry disease.
Topline results indicate that 2 mg/kg of PRX–102 administered every four weeks was found to be well tolerated, and stable clinical presentation was maintained in adult Fabry patients.
Plasma lyso–Gb3 concentrations remained stable during the study with a mean change of 3.01 nM from baseline (19.36 nM) to Week 52 (22.23 nM).
Mean absolute change of eGFR values were stable, with a mean change from baseline of –1.27 mL/min/1.73 m2.
The overall health mean scores were 78.3 (3.1) and 82.1 (2.9) at baseline and Week 52, respectively.
No new patients developed anti-drug antibodies following the switch to PRX–102 treatment.
This investigational therapy was well tolerated with potential to be an effective treatment for Fabry disease.
The Company intends to report final data in H2, and to present these findings at an appropriate medical conference.
Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells. Characteristic features include episodes of pain, particularly in the hands and feet; clusters of small, dark red spots on the skin; a decreased ability to sweat; cloudiness or streaks in the front part of the eye.
PLX up 6% premarket.