Protalix: Positive results in the treatment of Fabri – the capital market

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Also traded on the New York Stock Exchange publishes positive results from Phase 3 of the clinical study in its PRX-102 drug for the treatment of Fabry disease. The study shows clinical stability that has also been maintained in adult Fabri patients, with none of the patients developing antibodies to the drug. The company intends to publish the final data from the study in the second half of the year.

This is an open-label trial and 12-month treatment replacement aimed at evaluating the safety, efficacy, and pharmacokinetics of the new drug. It was performed in 30 Faber patients, 24 men and 6 women, with an average age of 40.5 years and a range of 19 to 58 years. In the previous three years, participants had taken at least one steady-state enzyme replacement drug (Replagal or Fabrazyme) every two weeks. In the Protelix trial, these were given a dose of 2 mg per kilogram of body weight every four weeks. The most common symptoms of Fabri’s disease are circumcision, fever intolerance, angioedema and hyperhidrosis.

“We are encouraged to note that all patients who completed this study chose to join the long-term follow-up study. So far, 80% of the patients recruited for this study have been treated in this treatment regimen for two years. We look forward to furthering the study and re-evaluating the results,” she said. Dr. Einat Brill Almon, Senior Vice President and Chief Development Officer of Protelix.

Almon added that “out of the 30 patients who participated, 20 remained negative in terms of neutralizing antibodies throughout the course of treatment. Of the 10 patients who were initially positive for antibodies to the drug, four became negative to neutralizing antibodies at 12 months, a fact that implies the development of tolerance.” “.

Protalix focuses on the development, production and commercialization of therapeutic recombinant proteins produced from plant cells. Casey’s Rare Diseases Division, an international research services group focused on research, is Protalix’s partner in product development and commercialization.

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