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Protalix Completes Enrollment in Third Fabry Disease Study

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Protalix BioTherapeutics, Inc. PLX announced that it has completed enrollment in the third phase III study, evaluating its pipeline candidate — PRX-102 (pegunigalsidase alfa) — for the treatment of Fabry disease, a rare inherited genetic lysosomal disorder.

The BALANCE study is designed to evaluate the safety and efficacy of PRX-102 compared to Fabrazyme (agalsidase beta) on renal function in Fabry patients with progressing kidney disease previously treated with agalsidase beta.

Fabrazyme, currently marketed by Sanofi SNY, is already approved for treating Fabry disease. Replagal too won the nod for addressing the same.

Shares of Protalix have slumped 33.5% so far this year compared with the industry’s decline of 3.2%.


BALANCE is the third phase III study on PRX-102. The first two studies — BRIDGE and BRIGHT — are both fully enrolled and ongoing.

Along with the press release, the company said it plans to submit a biologics license application (BLA) to the FDA under an accelerated approval pathway for PRX-102 in the first quarter of 2020. The BLA will be supported by results from the completed phase I/II studies of PRX-102 and the ongoing phase III BRIDGE clinical study.

Notably, in January 2018, the FDA granted a Fast Track designation to the candidate for the treatment of Fabry disease.

We would like to remind investors that Protalix has a single marketed drug, Elelyso, approved for treating Gaucher disease. The drug is marketed by Pfizer Inc. (PFE - Free Report) in the United States as part of an exclusive license and supply agreement.

The company is also developing OPRX-106 as an orally-delivered anti-inflammatory treatment. In 2018, it delivered positive results from the phase II OPRX-106 study for the treatment of ulcerative colitis.


Zacks Rank & A Stock to Consider

Currently, Protalix is a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the biotech sector is Acorda Therapeutics Inc. ACOR, carrying a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates for the current year narrowed from $3.51 to $2.74 over the past 60 days. The company recorded a positive earnings surprise in the preceding four quarters, the average beat being 69.68%.    

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