Protalix Biotherapeutics Inc (NYSEAMERICAN:PLX) closed Wednesday’s trading session at $0.46 up 2.07%. This has been the case since it announced that it would present Pegunigalsidase Alfa’s preliminary data from its BRIGHT Study during the 5th Annual WORLDSymposium™ 2019.
The conference was scheduled to take place between February 4 and February 8 this year at Orlando’s Hyatt Regency. Protalix had scheduled its oral presentation of the Pegunigalsidase Alfa’s BRIGHT Study for February 7 at 8:30 AM ET. pegunigalsidase alfa, AKA PRX-102 is the firm’s developmental plant cell-expressed recombinant which was designed as a plant cell-expressed recombinant for treating patients with Fabry disease.
Determining PRX-102’s safety and efficacy profile
The company launched the BRIGHT study as an open-label switchover study scheduled to run for 12 months to determine pegunigalsidase alfa’s safety and efficacy. Protalix plans to administer 2 mg/kg of the developmental drug to 30 fabry patients that previously underwent enzyme replacement therapy (ERT). Twenty-eight patients had signed up to the study as of December 23 last year, and 15 of them had previously gone through treatment for nine months.
Protalix carried out a pharmacokinetic (PK) evaluation on the 15 patients who went through treatment for nine months to determine whether they had anti-drug antibodies (ADA). The BRIGHT study results indicate that there was PRX-102 which was still active within the plasma during the 1-month infusion duration interval.
“The preliminary PK data from the BRIGHT study is very encouraging and suggest that PRX-102 has the potential to be effectively dosed every four weeks,” stated Myrl D. Holida, the lead investigator in the BRIGHT study.
Additionally, PRX-102 seems to be performing better than the enzyme replacement therapies (ERT) that are currently available in the market as treatments for Fabry disease. Most of these alternatives have to be administered every two weeks.
Fabry disease is a chronic condition that does not have a cure, and the only available option is taking treatments for managing the condition. Reducing the number of infusions is therefore essential to improve the patients’ quality of life.