Protalix Bio, Chiesi Release Final Results From Late-Stage PRX-102 Trial In Fabry Disease

Protalix BioTherapeutics Inc 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 α‑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.