Protalix Finishes Patient Enrollment for Fabry Disease Study - Analyst Blog
Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, biopharma company Protalix BioTherapeutics, Inc. (PLX) provided an update on its Fabry disease candidate, PRX-102. The company said that it has finished enrolling patients in an open-label, dose-ranging phase I/II study on PRX-102 for the treatment of Fabry disease.
The dose-ranging study is evaluating PRX-102 (0.2 mg/kg, 1 mg/kg and 2 mg/kg) in 18 treatment-naïve patients suffering from Fabry disease. Interim results from the 1mg dosage arm should be out in the third quarter with full results on all dosing arms expected in the fourth quarter of 2015. Protalix also intends to request the FDA for an end-of-phase II meeting in the fourth quarter of 2015, and start a phase III pivotal study in early 2016.
We note that earlier this month, Protalix had reported positive interim efficacy and safety data on PRX-102 for the 0.2 mg/kg dose.
Currently approved Fabry disease treatments include Sanofi’s (SNY) Fabrazyme and Shire’s (SHPG) Replagal.
With a single marketed product, Elelyso (Gaucher disease), in its portfolio, Protalix is working on advancing its pipeline and bringing new products to market.
Apart from PRX-102, the company’s pipeline has candidates like PRX-112 (Gaucher disease), PRX-106 (inflammatory bowel disease) and PRX-110 (cystic fibrosis).
Protalix carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Ophthotech Corp. (OPHT), sporting a Zacks Rank #1 (Strong Buy).
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