PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[n3m3sis]

Protalix Reports Positive Interim Data From Phase II Clinical Trial Of OPRX-106

(RTTNews) - Protalix BioTherapeutics, Inc. (PLX) announced positive interim data from the first 14 patients that have 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 company noted that 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 demonstrated that 57 percent of the patients achieved clinical response and 36 percent achieved clinical remission at week 8.

In the rectal bleeding analysis, a sub category of the Mayo score, 79% of those patients showed an improvement.

In addition, the majority of those patients showed improvement in the study's additional efficacy endpoints, with 86 percent of the patients achieving an improvement in calprotectin, a protein biomarker present in the feces indicating intestinal inflammation. 64 percent of patients had an improved Geboes score, a histopathological scoring for the assessment of disease activity in ulcerative colitis.

The treatment was well tolerated and the majority of adverse events have been mild to moderate and transient in nature, with headaches being the most common.

Protalix BioTherapeutics expects to report full results from this study by the end of the first quarter of 2018.

Source