WASHINGTON (dpa-AFX) - Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A. on Friday said late-stage study of PRX-102, which is being evaluated for the potential treatment of Fabry disease, achieved key objectives for safety, efficacy and pharmacokinetics.
Final data from the BRIGHT Phase 3 study showed that treatment with PRX-102 was well tolerated, and Fabry disease assessed by estimated glomerular filtration rate (eGFR) slope and plasma lyso-Gb3 concentration was stable.
PRX-102 is a plant cell-expressed recombinant, PEGylated, cross-linked ?-galactosidase, Protalix said.
Fabry disease, a rare, inherited disorder, results in the build up of certain type of fatty substance called globotriaosylceramide in body cells.
The companies said additional long-term data are being collected as part of an extension study.
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