Protalix Chiesi Global Rare Diseases announce final results of BRIGHT phase III trial evaluating PRX-102 to treat Fabry disease

Protalix BioTherapeutics, Inc., a biopharmaceutical company, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research focused healthcare Group (Chiesi Group), announced final results from the BRIGHT phase III clinical trial evaluating pegunigalsidase alfa (PRX-102) for the potential treatment of 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, and Fabry disease assessed by estimated glomerular filtration rate (eGFR) slope and plasma lyso-Gb3 concentration was stable. "We are excited to share the final data from the BRIGHT study, an important milestone in the progress of our PRX-102 clinical programme," said Dror Bashan, Protalix's president and chief executive officer. "The availability of this data for review by the US Food and Drug Administration, the European Medicines Agency and other regulators is another step forward towards the anticipated approval of PRX-102 as a potential good alternative for adult Fabry patients in both the regular 1 mg\kg every two weeks as well as the 2 mg\kg every four weeks regimen." PRX-102 is a plant cell-expressed recombinant, PEGylated, cross-linked a-galactosidase-A product candidate. The BRIGHT phase III clinical trial (NCT03180840) was a multicenter, multinational open-label, switch-over study designed to evaluate the safety, efficacy and pharmacokinetics of treatment with 2 mg/kg of PRX-102 administered every four weeks for 52 weeks (a total of 14 infusions). The study enrolled 30 adult patients with Fabry disease (24 males and 6 females) with mean (SD) age of 40.5 (11.3) years, ranging from 19 to 58 years, who previously received an approved enzyme replacement therapy (ERT) for at least three years on a stable dose administered every two weeks (agalsidase alfa

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