67% of patients have clinical response, and the second phase of colitis new drug reaches the primary end point
March 15, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Protalix BioTherapeutics has announced positive results in its Phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. OPRX-106 is a recombinant human tumor necrosis factor receptor II expressed in a plant cell fused to an IgG1 Fc domain (TNFRII-Fc) for oral administration. When administered orally and through the digestive tract, the plant cells function as a natural delivery vehicle with unique properties of the cellulosic cell wall that are resistant to degradation as compared to proteins produced by mammalian cell expression.
Ulcerative colitis is a chronic disease caused by a long-term immune response that is dysregulated, producing persistent inflammation and ulceration in the mucosa of the large intestine (colon). The condition recurs and the symptoms usually develop over time. The disease can debilitate the patient and sometimes lead to life-threatening complications. Ulcerative colitis is the most common inflammatory bowel disease worldwide, with one in every 198 in Europe and one in every 40 people in North America suffering from ulcerative colitis. According to statistics, more than 100,000 people were hospitalized for ulcerative colitis in 2010.
Phase 2 clinical trials of OPRX-106 were randomized, open-label and dual-arm studies. A total of 24 patients with active mild to moderate ulcerative colitis were included in the study. Patients were randomized to receive either 2 mg or 8 mg OPRX-106 once daily for 8 weeks. The average baseline Mayo score for the 18 patients who completed the treatment was 7.1, with 89% of patients with a Mayo score between 6 and 9 meeting the criteria for moderate disease activity. The study reached the critical clinical efficacy endpoint, with 67% of patients having clinical response and 28% having clinical remission.
In addition, 72% of patients showed improvement in stool function, including reduced rectal bleeding and inflammation. The Geboes score (a histopathological score used to assess the activity of ulcerative colitis) was improved in 61% of patients.
â–²Protalix BioTherapeutics R&D pipeline (Source: Protalix BioTherapeutics official website)
The data shows that OPRX-106 is safe and well tolerated, with only mild to moderate adverse events, which are basically transient. Headache is the most common adverse event.
“These data are very encouraging, suggesting that OPRX-106 has the potential to address the huge unmet medical needs for the treatment of ulcerative colitis. OPRX-106 is administered orally and is biologically active in the intestines and does not trigger the formation of anti-drug antibodies. OPRX-106 has the potential to address partial loss of response in anti-TNFα therapy, driven by the presence of neutralizing antibodies,†The Hadassah Hebrew University Medical Center, Jerusalem Professor Yaron Ilan, a department head and gastroenterologist, said, "In addition, OPRX-106 may avoid certain side effects such as malignant tumors and opportunistic infections by oral administration."
“We are very excited about these results,†commented Moshe Manor, President and CEO of Protalix. “This result demonstrates efficacy and lack of immunogenicity and beneficial safety, which may overcome current administration by injection and infusion. One of the most challenging shortcomings in ulcerative colitis therapy."
We wish the clinical research of OPRX-106 smooth and bring the gospel of treatment to patients with ulcerative colitis at an early date.
Reference materials:
[1] Protalix BioTherapeutics official website
[2] Protalix BioTherapeutics Treatment for Ulcerative Colitis Shows Positive Data
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