PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Protalix Bio, Chiesi Release Final Results From Late-Stage PRX-102 Trial In Fabry Disease
Vandana Singh
Fri, March 18, 2022, 3:54 PM

https://finance.yahoo.com/news/protalix-bio-chiesi-release-final-135418298.html

Protalix Biotherapeutics, Chiesi Global Rare Diseases Announce Final Results Of The Bright Phase III Clinical Trial

Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A, have announced final results from the BRIGHT Phase 3 trial of pegunigalsidase alfa (PRX-102) for Fabry disease.

The results indicate that treatment with 2 mg/kg of PRX-102 administered by intravenous (IV) infusion every four weeks was well tolerated.

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 a-galactosidase-A product candidate.

Overall, 33 of 182 total treatment-emergent adverse events (TEAEs) reported in nine (30.0%) patients were considered treatment-related; all were mild or moderate in severity, and the majority were resolved at the end of the study.

Additional long-term data is being collected as part of an extension study.

Recently, Protalix submitted a European marketing application for pegunigalsidase alfa for Fabry disease.

Price Action: PLX shares are up 15.4% at $1.07 during the market session on the last check Friday.