Protalix BioTherapeutics, Inc. Reports Positive Interim Data from Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis
January 02, 2018 at 07:00 am EST
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Protalix BioTherapeutics, Inc. announced interim data from the first 14 patients that completed, to date, the company’s phase II clinical trial of OPRX-106 (oral anti-TNF) in patients with ulcerative colitis. The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in patients with active mild to moderate ulcerative colitis. A total of 24 patients were enrolled and randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks. The first 14 patients have completed the study, and four patients are currently in treatment and follow-up. The trial evaluated key efficacy endpoints including clinical response and remission utilizing the Mayo score, as well as safety and pharmacokinetics. Data generated from the first 14 patients who completed the study demonstrates that 57% of the patients achieved clinical response and 36% achieved clinical remission at week 8. In the rectal bleeding analysis, a sub category of the Mayo score, 79% of those patients show an improvement. In addition, the majority of those patients show improvement in the study’s additional efficacy endpoints, with 86% of the patients achieved an improvement in calprotectin, a protein biomarker present in the feces indicating intestinal inflammation, and 64% have an improved Geboes score, a histopathological scoring for the assessment of disease activity in ulcerative colitis. Clinical response at week 8 is defined as a decrease in the Mayo score of at least 3 points and either a decrease in the sub-score for rectal bleeding of at least 1 point from baseline, or rectal bleeding sub-score of 0 or 1.
Protalix BioTherapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. In addition, the Company is developing PEGylated uricase, or PRX-115, for the treatment of severe gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and other technologies and preclinical assets. Its product, Elelyso is an enzyme replacement therapy (ERT) for the treatment of patients with Gaucher disease. Its ProCellEx platform is being used to manufacture both of its approved and marketed products as well as PRX-115 and PRX-119. PRX-115, a plant cell-expressed recombinant PEGylated Uricase (urate oxidase)- a chemically modified enzyme under development for the potential treatment of severe gout. PRX-119 is a plant cell-expressed PEGylated recombinant human DNase I product candidate.