Protalix Shares Trade up 70% Upon Release of Phase 3 Fabry Disease Data

Earlier today, Israel-based biopharmaceutical company Protalix Biotherapeutics Inc. (PLX:NYSE), which focuses on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, announced positive 12-month on-treatment data from the first 16 adult patients enrolled in its BRIDGE Phase 3 study.

The firm advised in the release "the BRIDGE study is an open label switch-over study evaluating the safety and efficacy of pegunigalsidase alfa (PRX-102), 1 mg/kg infused every two weeks, in up to 22 Fabry patients currently treated with agalsidase alfa (Replagal) for at least two years and on a stable dose for at least six months." The firm noted that in both male and female patients, the 12-month interim data from the first 16 of 22 adult patients enrolled demonstrate a mean improvement in kidney function when switched from agalsidase alfa to pegunigalsidase alfa.

Raul Chertkoff, M.D., Protalix's vice president of medical affairs, commented, "We previously announced positive preliminary results from 16 patients after six months in the BRIDGE study in September 2018, and these new results, after 12 months of treatment, further suggest the strong potential benefit of pegunigalsidase alfa on renal function for Fabry patients."

According to the clinical trial results, 100% of the progressing patients achieved the proposed therapeutic goals after switching to pegunigalsidase alfa, with the majority of the patients who completed the study rolling over into a long-term extension study, continuing their treatment with pegunigalsidase alfa. The company added that "pegunigalsidase alfa was found to be well tolerated in the study, with all adverse events being transient in nature without sequelae, and that most of the patients who were eligible for home care therapy per country regulation were treated under a home care arrangement in which certain of the scheduled infusions were performed at the patients' home."

The firm explains that Fabry disease, which occurs in one of every 40,000 people, is an "X-linked inherited disease that results from deficient activity of the lysosomal enzyme alpha galactosidase A resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body."

Protalix Biotherapeutics focuses on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. Protalix notes that it was the first company to "gain FDA approval of a protein produced through plant cell-based in suspension expression system." The company's development pipeline includes the following product candidates: pegunigalsidase alfa, OPRX-106, an orally delivered anti-inflammatory treatment, and alidornase alfa for the treatment of Cystic Fibrosis alfa.

Protalix Biotherapeutics started off today with a market capitalization of about $26.9 million with approximately 148.4 million shares outstanding. PLX shares opened more than 70% higher today on the news at $0.31 (+$0.129, +71.27%) compared to the prior day's $0.181 closing price. The stock usually trades less than 300,000 shares per day, but today has already traded more than 26 million shares between $0.2863 and $0.47 per share and is presently trading at $0.3151 (+$0.1341, +74.09%).


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