Pegunigalsidase alfa treatment for Fabry disease achieves safety, efficacy goals
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Protalix BioTherapeutics Inc. and Chiesi Global Rare Diseases announced final results of the BRIGHT phase 3 clinical trial showing safety and efficacy of pegunigalsidase alfa as treatment for Fabry disease.
According to the press release, pegunigalsidase alfa (PRX-102) achieved safety, efficacy and pharmacokinetics.
In the multicenter, multinational open-label, switch-over BRIGHT phase 3 clinical trial, researchers examined 30 adults with Fabry disease who received an enzyme replacement therapy every 2 weeks for at least 3 years.
Researchers administered at least one dose of PRX-102 to patients during the study period. No patient experienced a serious adverse event or developed treatment-induced anti-drug antibodies to PRX-102.
“We are excited to share the final data from the BRIGHT study, an important milestone in the progress of our PRX-102 clinical program,” Dror Bashan, president and CEO of Protalix, said in the release. “The availability of this data for review by the[FDA] , 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 2 weeks as well as the 2 mg\kg every 4 weeks regimen.”
All patients joined an extension study in which researchers intend to evaluate additional long-term data. Protalix and Chiesi Global Rare Diseases plan to present final results at upcoming medical conferences.
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