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Protalix BioTherapeutics and Chiesi Report Results of PRX-102 in P-III (BALANCE) Trial for the Treatment of Fabry Disease

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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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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