HIV potential new drug anti-inflammatory effect strong drug-resistant colitis clinical phase II results positive
September 07, 2018 Source: Sina Pharmaceutical News
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)];Abivax is a French biotechnology company dedicated to the development of HIV functional curative therapies and new therapies for inflammatory/autoimmune diseases and cancer. Recently, the company announced positive top-line data for a phase IIa clinical study ABX464-101 for experimental drug ABX464 in the treatment of ulcerative colitis (UC). The data shows that ABX464 has good safety and tolerability and has shown significant efficacy in clinical and endoscopic endpoints.
ABX464-101 is a randomized, double-blind, placebo-controlled Phase IIa study conducted in 32 patients with moderate to severe UC who were treated with immunomodulators (anti-TNF岬タ埂edolizumab and/or corticosteroids). Evaluate the efficacy and safety of ABX464 over two months of placebo treatment. In the study, patients were randomized to receive a daily oral dose of 50 mg of ABX464 tablets or placebo in a 2:1 ratio. Of these 32 patients, 29 patients completed the study as planned.
The data showed that after 8 weeks of treatment, 35% of patients in the ABX464 treatment group achieved clinical remission, compared with 11% in the placebo group. Mucosal healing was achieved in 50% of patients in the treatment group (11% in the placebo group), with statistically significant differences (p < 0.03); the clinical response rate was 70% (30% in the placebo group). In addition, the treatment effect of ABX464 was rapid, and the difference in the partial Mayo score between ABX464 and placebo was observed in the first evaluation two weeks after treatment. This difference reached statistical significance at the 8th week of treatment. Nature (p < 0.02). Similarly, the Mayo total score also reached a statistically significant difference after 8 weeks of treatment (p < 0.03). In UC, calprotectin was the best biomarker for the study. After 4 weeks of treatment, the level of calprotectin in the ABX464 treatment group was significantly reduced by 4.4-fold from baseline, and the placebo group was 1.6-fold lower than baseline.
In this study, ABX464 was safe and consistent with previous studies; the drug was well tolerated and no serious adverse effects were observed in the study. Detailed research data will be published at future medical conferences.
ABX464 is a first-in-class oral small molecule drug originally developed for the treatment of HIV, which inhibits HIV replication through a unique mechanism of action and has been shown in preclinical studies. Strong anti-inflammatory effect. The drug can increase IL-22 expression in macrophages by a factor of 50. IL-22 is a cytokine known as a potent inhibitor of the inflammatory process. Furthermore, in peripheral blood mononuclear cells, ABX464 enhanced the expression of miR124 of anti-inflammatory microRNA by >10-fold. Inflammation is the root cause of many diseases, not only HIV, but also many other diseases, such as inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease).
IBD is an idiopathic disease caused by an imbalance in the immune response of the host gut microflora. The two main types of IBD are ulcerative colitis (UC), which is limited to the colon, and Crohn's disease (CD) can affect any part of the gastrointestinal tract from the mouth to the anus. There is a genetic predisposition in IBD, and patients with this disease are more likely to develop malignant tumors.
ABX464 also enhances the splicing of two types of RNA by binding to the CAP binding complex (CBC) triggering effect, one of which is associated with enhanced expression of miR124, a potent anti-inflammatory microRNA. In early July, Abivax announced data on phase IIa clinical trials of ABX464 for HIV treatment, which for the first time confirmed that ABX464 has the ability to reduce HIV DNA in blood and rectal tissue pools, providing new hope for functional hepatitis.
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