Chinese and foreign researchers have jointly proven an innovative drug effective in treating moderate and severe ulcerative colitis, an inflammatory bowel disease (IBD), bringing a new treatment option.
As a group of chronic inflammatory diseases, IBDs mainly include ulcerative colitis and Crohn’s disease.
They are prone to recurrent attacks, with pathogenesis not fully understood yet. Interleukin-6 (IL-6) is believed to be a key mediator of their pathogenesis according to the researchers.
The existing drugs have shown poor curative effects on IBDs, so the treatment strategy is to control symptoms and prevent their recurrence by suppressing overactive immune responses.
The innovative domestic drug, olamkicept, is a soluble fusion protein and can selectively inhibit the IL-6 trans-signaling.
During its phase 2 clinical trials, a joint team led by researchers from the First Affiliated Hospital of Sun Yat-sen University (FAH), in collaboration with counterparts from 22 hospitals and research centers in East Asia, conducted a randomized, double-blind, and placebo-controlled study.
Zhang Shenghong, a team member from the FAH said a total of 91 adult patients with active ulcerative colitis, with an average age of 41, were included in the study, starting from February 2018.
They were randomly divided into three groups of nearly equal numbers and received an intravenous infusion of olamkicept with a dose of 600 milligrams or 300 milligrams, or placebo, respectively, for 12 weeks.
The results indicated that olamkicept with a dose of 600 milligrams showed a curative effect on patients with moderate and severe ulcerative colitis by significantly improving their clinical symptoms and biological indicators.
Chen Minhu, the team leader from the FAH said the drug is safe and well tolerated and can effectively reduce complications and mortality in patients with IBDs.
He said it will enter phase 3 clinical trials this year adding that the previous research results have been published in The Journal of the American Medical Association.
