Taliglucerase alfa
- Generic Name
- Taliglucerase alfa
- Brand Names
- Elelyso
- Drug Type
- Biotech
- CAS Number
- 37228-64-1
- Unique Ingredient Identifier
- N69L6LM4QU
- Background
Taliglucerase alfa is the recombinant active form of the human lysosomal enzyme, β-glucocerebrosidase. It was approved in 2012 and is marketed under the name Elelyso for use in patients with type 1 Gaucher's disease.
- Indication
For the treatment of adult Type 1 Gaucher disease.
- Associated Conditions
- Gaucher Disease, Type 1, Gaucher Disease, Type III
Protalix's PRX-115 Shows Promise in Phase I Gout Trial with Extended Dosing Potential
Protalix BioTherapeutics has completed a Phase I trial for PRX-115, demonstrating positive safety profile and prolonged urate-lowering effects in gout patients. The study results suggest potential advantages over current treatments, including reduced infusion frequency compared to existing therapies like Krystexxa.
Protalix BioTherapeutics Advances Pipeline and Receives EMA Validation for Fabry Disease Treatment
• Protalix BioTherapeutics announced the validation by the EMA of Chiesi's variation submission for pegunigalsidase alfa, aiming for less frequent dosing for Fabry disease.
• A Phase I clinical trial of PRX-115, a recombinant PEGylated uricase for uncontrolled gout, showed promising safety and efficacy results with potential for wide dosing intervals.
• Protalix is refining its R&D strategy, focusing on plant-based drug delivery systems for renal rare diseases, leveraging its ProCellEx platform.
• The company reported satisfaction with sales growth of Elfabrio to Chiesi, Elelyso to Pfizer, and Uplyso to Brazil, and has fully repaid its outstanding convertible notes.
Protalix's PRX-115 Demonstrates Promising Results in Phase I Gout Trial
• Protalix Biotherapeutics' PRX-115 shows dose-dependent reduction in plasma urate levels in Phase I trial for severe gout.
• The Phase I trial demonstrated that PRX-115 was well-tolerated, with most adverse events being mild and resolving completely.
• PRX-115 exhibited prolonged presence in plasma, up to 12 weeks, suggesting potential for less frequent dosing compared to existing treatments.
• Protalix is planning a Phase II trial for PRX-115, with the trial design expected in the coming quarters and a launch anticipated in the second half of 2025.
Drug Development Updates
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