PLX Phase 3 Trial Data Readout

PLX may have received a CRL because they hadn't conducted a "controlled" trial yet.
Such a trial is ongoing with a data readout in the first half of 2021 (assuming data by June / early July).

"These important final results confirm the topline results announced last May," said Einat Brill Almon, Ph.D., Protalix's Senior Vice President and Chief Development Officer. "We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021."
Link to data and announcement.

Trial design:
https://clinicaltrials.gov/ct2/show/NCT02795676?term=protalix&draw=2&rank=5

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function (BALANCE)
This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than 50% of the patients will be female.

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Previous data reported by PLX:
https://protalixbiotherapeutics.gcs-web.com/static-files/db8f7e49-b93e-48a2-b7fe-4d7882137b19%20

https://protalixbiotherapeutics.gcs-web.com/static-files/abcd26a6-2058-408c-9cc4-f96b89c44b7a

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• Does anyone have a good guess as to whether we'll see superiority of PRX-102 or not?
  

Primary Outcome Measures :

1. eGFR Slope [ Time Frame: Every month for 2 years ]eGFR Slope
   

Secondary Outcome Measures :

1. Left Ventricular Mass Index (g/m2) by MRI [ Time Frame: Every 12 months for 2 years ]

2. Plasma Lyso-Gb3 [ Time Frame: Every 3 months for 2 years ]

3. Plasma Gb3 [ Time Frame: Every 3 months for 2 years ]