Protalix Alleviates Ulcerative Colitis, Sending Some Cases Into Remission, Phase 2 Trial Shows

Protalix Alleviates Ulcerative Colitis, Sending Some Cases Into Remission, Phase 2 Trial Shows
Protalix BioTherapeuticsOPRX-106 alleviated ulcerative colitis and in some cases sent it into remission, a Phase 2 clinical trial shows . OPRX-106 is a TNF inhibitor that Protalix scientists grew from a plant cell to resist gastrointestinal degradation better than proteins from animals cells. TNF inhibitors are used worldwide to treat inflammatory bowel disease, which includes  Crohn’s as well as ulcerative colitis. They reduce inflammation and stop disease progression by targeting an inflammation-causing substance called tumor necrosis factor, or TNF. Most anti-TNF drugs are administered by injection, but OPRX-106 is a pill. Before OPRX-106 entered clinical trials, studies in mice showed it could alleviate bowel diseases. It improved symptoms and increased blood levels of anti-inflammatory biomarkers. The Phase 2 trial (NCT02768974) included 24 patients with mild to moderate ulcerative colitis. Patients were randomized to receive either 2 mg or 8 mg of OPRX-106 once a day for eight weeks. Eighteen of the patients completed the trial. OPRX-106 was found to be safe and well tolerated, with headaches the most common adverse event. Sixty-seven percent of patients' ulcerative colitis improved significantly from the treatment. At week eight, 28 percent of patients' disease had gone into remission — that is, they were symptom-free. In addition, 72 percent of patients' rectal bleeding decreased. The same percentage had less fecal calprotectin, a biomarker of gastrointestinal inflammation. Microscope examination of intestinal tiss
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