Wired News - Protalix BioTherapeutics Presents Data About Fabry Disease Patients Screened in Phase-III BALANCE Study
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The presentation discussed the characteristics of Fabry disease patients screened in the phase-III BALANCE clinical trial of pegunigalsidase alfa. Pegunigalsidase alfa is a PEGylated alfa Galactosidase alfa enzyme, or PRX-102, which is meant for the treatment of Fabry disease.
About the Presentation
Dr. David Warnock, the Director of the Nephrology division and Professor of Medicine and Physiology at the University of Alabama at Birmingham, presented the poster titled: ''Progression of nephropathy in Fabry patients receiving enzyme replacement therapy (ERT); relation to anti-drug antibodies (ADA) status and proteinuria''. The poster discussed the key baseline characteristics of the initial 37 patients (27 males and 10 females), who were screened for the BALANCE study, as of January 2018. These characteristics include presence of anti-drug antibodies (ADA) toward agalsidase beta (Fabrazyme), cross recognition of those ADAs to pegunigalsidase alfa, annualized eGFR slope and proteinuria at screening.
About BALANCE Study
The BALANCE study is a head-to-head blinded comparison study of pegunigalsidase alfa to agalsidase beta (Fabrazyme) with 1 mg/kg every two weeks, with change in eGFR as the primary end-point. Besides, the BALANCE study also evaluated a comprehensive range of clinical endpoints such as pain, quality of life parameters, biomarkers and others. The study enrolled Fabry patients who continued to lose kidney function even after receiving standard enzyme replacement therapy.
Results of the BALANCE Study
The results show that 15 out of the 27 screened male patients were ADA positive. All these 15 patients had neutralizing antibodies to Fabrazyme while 14 out of them also had neutralizing activity toward pegunigalsidase alfa as part as ex-vivo immunogenicity testing.
Titers measured in ADA against Fabrazyme exceeded those measured against pegunigalsidase alfa by an average of more than double.
Moreover, Fabrazyme was inhibited by an average of 83.6% with 16.4% of effective enzyme left compared to pegunigalsidase alfa, which was inhibited by 61.6%, with 38.4% effective enzyme left.
The analysis of patients' history showed that the average annualized eGFR slope for the 15 male patients who tested positive for ADA was -7.9 (SD=6.0) mL/min/1·73m2/year, implying that the Fabry disease patients screened for the BALANCE study progressively lost kidney function, even after being treated with Fabrazyme for 1 to 12 years. And the average urine protein creatinine ratio for proteinuria was 767 (SD=546) mg/gr for male patients.
It must be noted that no ADAs were present in the 10 female patients screened.
These results were in-line with the results from recent analysis of 60 patients screened for the BALANCE study till date. The results implied that the remaining effective enzyme in blood samples was more than double for pegunigalsidase alfa in comparison to Fabrazyme.
Pegunigalsidase Alfa Has the Potential to Stabilize Renal Function
There are a number of patients with Fabry disease who continue to show progressive loss of renal function despite years of treatment with agalsidase beta. Neutralizing antibodies cause the progressive loss of kidney function and proteinuria in Fabry disease patients. However, it has been found that preexisting neutralizing antibodies inhibit Pegunigalsidase alfa lesser than Fabrazyme. Besides, Pegunigalsidase alfa also has a longer half-life. Therefore, it is believed to have the potential to control proteinuria and stabilize renal function in patients who have not had an optimal clinical response to agalsidase beta.
Stock Performance Snapshot
May 29, 2018 - At Tuesday's closing bell, Protalix BioTherapeutics' stock slightly declined 0.72%, ending the trading session at $0.44.
Volume traded for the day: 143.32 thousand shares.
Stock performance in the last month - up 5.79%
After yesterday's close, Protalix BioTherapeutics' market cap was at $64.60 million.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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