Protalix reports ‘positive’ preliminary data from Fabry Disease study Protalix announced “positive” preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry disease, stating that additional data will be released at the 1st Canadian Symposium on Lysosomal Diseases 2018. Preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function when switched from agalsidase alfa to pegunigalsidase alfa, the company said. Based on available historical serum creatinine and study 3 month screening period values for approximately 2 years while treated with agalsidase alfa before switching to pegunigalsidase alfa treatment, the annualized estimated glomerular filtration rate slope for patients on Replagal was -6.8ml/min/1.73m. The mean eGFR slope for the same patients following six months of treatment with pegunigalsidase alfa was changed to be +3.7ml/min/1.73m , these results were statistically significant. Baseline characteristic of these patients were: mean estimated glomerular filtration rate 75.40 and 86.03 mL/min/1.73m2 for males and females, with annualized eGFR slope of -8.0 and -5.1 mL/min/1.73m2/year, respectively.
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