Lilly colitis drug mirikizumab released positive data for Phase II trial
Lilly colitis drug mirikizumab released positive data for Phase II trial
June 08, 2018 Source: Sina Pharmaceutical
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)];A few days ago, Eli Lilly's experimental drug mirikizumab released mid-term research data. Tests have shown that the drug achieves a higher clinical response rate and response rate in patients with ulcerative colitis.
Data released on Tuesday showed that after 12 weeks of treatment with mirikizumab, the clinical remission rate for patients with ulcerative colitis reached 12%-23%, compared with 4.8% for the placebo group (200 mg dose correction group compared with placebo: Nominal p < 0.05; other treatment groups did not produce significant p values). The subjects in the trial were patients with moderate to severe colitis who had previously had poor efficacy with traditional or other biological treatments and were primarily used to assess differences in safety and efficacy between mirikizumab and placebo.
In this trial, patients will be randomized to receive the drug at a dose of 50 mg or 200 mg, and may increase to a fixed dose of 600 mg at a later stage. The primary and secondary endpoint of the trial was the proportion of patients who achieved clinical remission, clinical response, endoscopic healing, endoscopic remission, and symptom relief at week 12 of mirikizumab treatment.
The trial was a multicenter, randomized, double-blind, placebo-controlled study in which the response rate of the drug was 41.3%-59.7%, compared with 20.6% in the control group. At the same time, endoscopic remission rate and symptom relief were shown in the drug treatment group compared with placebo. The drug was also safer and did not differ significantly from the placebo group. Common adverse events include anemia, pain, nasopharyngitis, and the like.
Eli Lilly plans to begin a third-stage study of mirikizumab for moderate to severe ulcerative colitis later this year. At the same time, mirikizumab is also actively developing research on other immune diseases, including psoriasis and Crohn's disease. The trial of moderate to severe plaque psoriasis is in the phase III clinical stage.
Mirikizumab belongs to the human IgG4 monoclonal antibody and can be targeted and integrated with the p19 subunit of IL-23 after entering the patient. If the monoclonal antibody of the IL-23p19 subunit finally passes the test and enters the market, it may become a new treatment.
Although there are many options for the treatment of ulcerative colitis, there are still few treatments that can achieve sustained clinical remission. Ulcerative colitis and Crohn's disease are the two most common types of inflammatory bowel disease. The US Centers for Disease Control and Prevention reported in 2015 that about 1.3% of adults in the United States were diagnosed with inflammatory bowel disease, compared with 0.9% in 1999.
Inflammatory bowel diseases are now known treatments including TNF inhibitors Humira (adalimumab) and Remicade (infliximab). Experimental treatments include sphingosine-1-phosphate receptor-1 (S1P1) agonists (such as neoyl ozanimod) and JAK inhibitors (such as Abbott upadacitinib).
William Sandborn, head of the Department of Gastroenterology at the University of San Diego School of Medicine in California, said, "I am very satisfied with the current symptom response and mitigation data obtained from this trial, and I look forward to receiving more positive data in future research to provide more positive data. The patient received the endoscopy results after a longer period of treatment and the status of continuous improvement." (Sina Medical Compilation / Fan Dongdong)
Article, picture reference source: Lilly's experimental colitis drug posts positive Phase 2 data
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