Protalix BioTherapeutics, Inc. (PLX), and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici, reported final study results from the BRIDGE phase III switch-over clinical trial evaluating Pegunigalsidase Alfa for the treatment of Fabry Disease. Final results showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to pegunigalsidase alfa (PRX-102). Following the switch to PRX-102, there was a decrease in patients with progressing or fast progressing kidney disease, and most patients achieved a stable status post-switch. PRX-102 was well-tolerated in the study.
Dror Bashan, Protalix's CEO, stated: "We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application."
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