BRIDGE Phase III trial of PRX 102 shows benefit in renal function in Fabry Disease.- Protalix BioTherapeutics and Chiesi

Protalix BioTherapeutics and Chiesi Global Rare Diseases announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating PRX 102 (pegunigalsidase alfa) for the treatment of Fabry Disease. The BRIDGE study was a Phase III 12 month open-label, single arm switch-over study evaluating the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in up to 22 Fabry patients previously treated with agalsidase alfa, marketed by Takeda Pharmaceutical Company Limited (formerly Shire Plc) as Replagal, for at least two years and on a stable dose for at least six months. Final results of the data generated in the study 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 PRX 102. Twenty of twenty-two patients completed the 12-month treatment duration. Eighteen of the patients who completed the study opted to roll over to a long-term extension study and continue to be treated with 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, with all adverse events being transient in nature without sequelae. Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea. An immunogenicity assessment indicated that four out of 20 patients (20%) developed persistent antidrug antibodies over the course of the study, of which two had neutralizing activity.