Clinical Data
Preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function when switched from agalsidase alfa (Replagal®) to pegunigalsidase alfa (PRX-102).  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 (eGFR) slope for patients on Replagal was (negative) --6.8ml/min/1.73m2 .  The mean eGFR slope for the same patients following six months of treatment with pegunigalsidase alfa (PRX-102) was changed to be (positive) of +3.7ml/min/1.73m2, these results were statistically significant.  Baseline characteristic of these patients were: mean estimated glomerular filtration rate (eGFR) 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.The BRIDGE study is an open-label, single arm switch-over study to assess the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in 22 Fabry patients currently treated with Replagal.  Protalix anticipates completing patient enrollment in the BRIDGE trial in the fourth quarter of 2018.