PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[king oil]

Protalix BioTherapeutics Due Off Halt at 1110 AM ET, Says Fabry Disesase Treatment Study Data Positive So Far

11:12 AM EDT, 09/21/2018 (MT Newswires) -- Protalix BioTherapeutics (PLX) shares are halted. The company said preliminary data from the BRIDGE study of pegunigalsidase alfa (PRX-102) to treat Fabry disease in 16 patients demonstrated an improvement in kidney function when switched to pegunigalsidase alfa (PRX-102) from agalsidase alfa (Replagal).

The BRIDGE study is an open-label, single arm switch-over study to assess the safety and efficacy of pegunigalsidase alfa, 1 mg/kg infused every two weeks, in 22 Fabry patients currently treated with Replagal. Protalix anticipates completing patient enrollment in the BRIDGE trial in Q4.

PRX-102 is the company's plant cell-expressed recombinant, PEGylated, cross-linked -galactosidase-A for Fabry disease. In pre-clinical and clinical studies, PRX-102 demonstrated higher stability in plasma, a longer half-life and higher exposure in Fabry disease patients, and a reduction in Gb3 in kidney biopsies in treatment na ve Fabry patients, the company said.