- Protalix BioTherapeutics Inc (NYSE:PLX) and Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., have announced topline data from the BALANCE Phase 3 trial evaluating pegunigalsidase alfa (PRX–102) for Fabry disease.
- PRX–102 is a PEGylated enzyme substitute therapy (ERT)
- The study met its prespecified primary endpoint and demonstrated that PRX-102 was statistically non-inferior to agalsidase beta.
- The median of the estimated glomerular filtration rate (eGFR) slope in the PRX-102 arm was –2.514 mL/min/1.73 m2/year (–3.788, –1.240) and –2.155 mL/min/1.73 m2/year (–3.805, –0.505) in the agalsidase beta arm.
- Related: Protalix Bio, Chiesi Release Final Results From Late-Stage PRX-102 Trial In Fabry Disease.
- Forty-seven (90.4%) patients in the PRX–102 arm experienced at least one adverse event than 24 (96.0%) in the agalsidase beta arm.
- Treatment-related adverse events were reported for 21 (40.4%) patients in the PRX–102 arm compared to 11 (44.0%) in the agalsidase beta arm.
- The infusion-related reactions adjusted to 100 infusions are 0.5 for the PRX–102 arm and 3.9 for the agalsidase beta arm.
- Price Action: PLX shares are up 81.40% at $1.91 during the market session on the last check Monday.
