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Also known as PRX-102, PRX-102 (pegunigalsidase alfa), Pegunigalsidase alfa
Pegunigalsidase alfa (PRX-102) · 5 trials · 1 indication
| Name | Type | Description |
|---|---|---|
| PRX-102 (pegunigalsidase alfa) | BIOLOGICAL | PRX-102 1 mg/kg every 2 weeks |
| agalsidase beta | BIOLOGICAL | agalsidase beta 1 mg/kg every 2 weeks |
| Pegunigalsidase alfa | BIOLOGICAL | Pegunigalsidase alfa 2 mg/kg every 4 weeks |
| PRX-102 | DRUG | - |
Pegunigalsidase alfa (PRX-102) is being developed for the treatment of Fabry disease, a rare genetic disorder. It is an enzyme replacement therapy studied in patients with Fabry disease, including patients previously treated with other enzyme replacement therapies such as agalsidase alfa and agalsidase beta.
Pegunigalsidase alfa (PRX-102) is being developed by Protalix BioTherapeutics, Inc., which trades under the ticker PLX. The company is the sponsor behind the clinical development program for this enzyme replacement therapy in Fabry disease.
Pegunigalsidase alfa (PRX-102) is in Phase 3 clinical development for Fabry disease. Its clinical program includes Phase 3 trials along with an earlier Phase 1/Phase 2 extension study, and the trials listed for the program are recorded as completed.
Pegunigalsidase alfa (PRX-102) has been studied in completed trials including NCT03180840, a Phase 3 study of intravenous dosing every 4 weeks; NCT03018730, a Phase 3 study in patients previously treated with agalsidase alfa; NCT02795676, a Phase 3 study comparing it to agalsidase beta on renal function; and NCT01981720, a Phase 1/Phase 2 extension study of up to 60 months.
Yes, pegunigalsidase alfa and PRX-102 refer to the same investigational enzyme replacement therapy for Fabry disease. PRX-102 is the development code used by Protalix BioTherapeutics, and pegunigalsidase alfa is the drug name used for the same asset.
Across the five completed clinical trials of pegunigalsidase alfa (PRX-102) in Fabry disease, total enrollment is 163 patients. Individual trial sizes range from 15 patients in the Phase 1/Phase 2 extension study to 78 patients in the Phase 3 comparison against agalsidase beta.