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HMS5552 Phase III clinical study was launched!
2017-05-16
来源：转载自第三方
16 May 2017
May 14, the phase III clinical study of new glucokinase activator HMS5552 pioneered by Hua Medicine was launched. The research and development of HMS5552 may open a new chapter of Chinese drug research and treatment of diabetes in the history.
Type II diabetes is progressive disease because the human body can not effectively use insulin. In the past few decades, the number and prevalence of diabetes have steadily increased. There are currently more than 450 million people in the world suffering from diabetes, and China has become country with the largest number of diabetes in the world, there are about 110 million people with diabetes, which count about 1/10 of the total number of adults.
If it can not be getten effective control, the disease will affect other parts of the body, causing retinopathy, kidney disease, neuropathy and coronary artery, cerebrovascular and peripheral vascular disease complications. The current oral hypoglycemic agents includes insulin secretion promoters such as sulfadiazine and repaglinide, insulin sensitizers such as biguanides (metformin) and glitazones, and glucosidase inhibitors such as Vildagliptin (intermediate 3-amino-1-adamantanol). In the premise of more effective and more convenient, many pharmaceutical companies committed to the development of diabetes drugs, hoping to control blood sugar as much as possible, and reduce side effects.
HMS5552 is a new mechanism—by regulating the glucose kinase target to control the body's blood glucose metabolism. Glucose kinase is an important enzyme to regulate glucose levels in the blood, mainly in liver cells and islet cells. Under normal physiological conditions, the main role of glucose kinase is to monitor blood glucose levels. When glucose levels in the blood rise, glucose kinase can reduce blood glucose levels in two ways: on the one hand the glucokine kinase in pancreatic islet cells promote insulin secretion; on the other hand, glucokines in hepatocytes can directly promote glycogen synthesis. The reduction of glucose kinase activity will be leading to high blood glucose levels, which will lead to type 2 diabetes and hyperglycemia. HMS5552 can increase the activity of glucose kinase to reduce the blood glucose levels of diabetic patients to achieve the purpose of treatment of diabetes.
At the beginning of 2012, Hua Medicine received all of the preclinical and clinical R & D documents, APIs and possible property right of follow-up compounds from Roche Pharmaceuticals' Glucokinase Agonist Program, and began the development of HMS5552, making this new drug meet patients in China firstly. In October 2016, Phase II clinical trials of HMS5552 obtained the first positive results of similar drugs in the world, the statistical results show significant effect. In addition, the test results also show that HMS5552 has excellent tolerance and safety.
Approved by the relevant departments, Hua medicine is about to start phase III clinical research, and will continue to explore the clinical mechanism of HMS5552 and drug combination in the United States and Europe. Phase III will be divided into two studies, including monotherapy treatment and combination with metformin in the study of more than 450 cases and 700 cases of type 2 diabetes patients, the phase III clinical study results is expected to be published after one year at the earliest.
Glucose kinase activator is a clinical development product introduced in combination with the pathogenesis and clinical needs of Chinese diabetic patients. It has the characters of global leading, best in similar products and new mechanism. It will bring new expectations to Chinese and even global diabetes patients. At the same time, the R & D of GHS5552 is an important milestone in China's innovative drug research and development process, which represents that China's innovative drug independent clinical research and development has been close to or reach the international advanced level.
Related links: 1,1-metformin hydrochloride
3-amino-1-adamantanol
3-amino-1-adamantanol
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.
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