Protalix BioTherapeutics and Chiesi Report Results of PRX-102 in P-III (BALANCE) Trial for the Treatment of Fabry Disease
Shots:
- The P-III (BALANCE) trial evaluates PRX–102 (1mg/kg, q2w) vs agalsidase beta in a ratio (2:1) in 78 patients with FD. The BLA resubmission is expected in H2’22
- The study met the pre-specified 1EPs i.e., the therapy was non-inferior to agalsidase beta in ITT & PP analysis, 47 (90.4%) vs 24 (96.0%) patients experienced one AES, TRAEs {21 (40.4%) vs 11 (44.0%)}, At the end of the study, 3 out of 47 (6.4%) vs 24 (12.5%) patients used infusion premedication
- For PRX–102 & agalsidase beta, 18 (34.6%) & 8 (32.0%) were ADA+ at baseline in which 17 (94.4%) & 7 (87.5%) had neutralizing Ab activity. At the end of 2yr. study, 11 (23.4%) & 6 (26.1%) were ADA+, 7 (63.6%) & 6 (100%) had neutralizing Ab activity, 6 were discontinued the study
Ref: Protalix | Image: PR Newswire
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