Protalix BioTherapeutics Announces Additional Positive Results from Final Analysis of the Phase II Clinical Trial of OPRX-106 for the Treatment of Ulcerative Colitis

Protalix BioTherapeutics (NYSE American:PLX) (TASE:PLX), announced today that additional positive results from the Company’s phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis (UC) were presented at the Digestive Disease Week® (DDW) 2018 Annual Meeting.  OPRX-106 is a plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc), in development for oral administration.

As quoted in the press release:

When administered orally and passing through the digestive tract, the plant cells function as a natural delivery vehicle.  The unique attribute of a cellulose plant cell wall provides resistance to degradation as opposed to proteins produced via mammalian cell expression.  The Digestive Disease Week® (DDW) 2018 Annual Meeting is taking place in Washington, D.C., June 2-5, 2018.

The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 for the treatment of ulcerative colitis (UC).  A total of 24 patients were enrolled in the study, 18 patients completed the study with 6 patients who did not complete the study.  The dropout rate is consistent with other trials in similar patient populations, and none of the patients dropped out due to a side effect or serious adverse event.  Patients were randomized to receive 2 mg or 8 mg of OPRX-106, administered orally, once daily, for 8 weeks.

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