PRX-102 Effectively Treats Fabry Disease in Phase 3 Data

The final results of the BRIGHT phase 3 clinical trial were announced by Protalix BioTherapeutics and Chiesi Global Rare Diseases. The trial evaluated PRX-102 (pegunigalsidase alfa) as treatment for individuals with Fabry disease.

The study successfully achieved safety, efficacy and pharmacokinetic objectives. All participating patients enrolled in the extension study following the completion of the trial.

When patients with Fabry disease were treated with 2 mg/kg of PRX-102 by intravenous (IV) infusion every 4 weeks, the results showed that their condition was stable. To assess stability, investigators estimated glomerular filtration rate (eGFR) slope and plasma lyso-Gb3 concentration.

Click here to read the full article at HCP Live

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Stock image by tatsianama