When will a new drug for Alzheimer's disease be on the market
The reporter learned from the Shanghai Institute of pharmacy, Chinese Academy of Sciences on the 2nd that a new drug for the treatment of Alzheimer's disease developed by Ocean University of China, Shanghai Institute of pharmacy, Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd. has been approved by the State Drug Administration and can be used for mild to moderate Alzheimer's disease and improve patients' cognitive function. The drug is the world's first market and will provide patients with new treatment options.
This original new drug called "phase 9-1" (mannate sodium, code gv-971) has been successfully developed by a team led by Geng Meiyu, a researcher at the Shanghai Institute of pharmacy, Chinese Academy of Sciences, for 22 years with the continuous efforts of Ocean University of China, Shanghai Institute of pharmacy, Chinese Academy of Sciences and Shanghai Green Valley pharmaceutical.
Alzheimer's disease is commonly known as Alzheimer's disease. Once it is ill, people's memory, thinking and judgment will be slowly wiped away like an eraser in their mind. According to the statistics of the international Alzheimer's Association, there are about 48 million patients worldwide, and a new case will be added every three seconds. With the gradual aging of the population, the harm of Alzheimer's disease is becoming more and more obvious.
There are only a few drugs for clinical treatment of Alzheimer's disease in the world. Major pharmaceutical companies have invested heavily in the research and development of new drugs in the past 20 years, most of which have failed. There have been no new drugs in this field for 17 years.
It is understood that a total of 1199 subjects participated in the phase 1, 2 and 3 clinical trials of phase 9 and phase 1. The third clinical phase was organized by the mental health center affiliated to the Medical College of Shanghai Jiaotong University and Beijing Union Medical College Hospital and carried out in 34 class III class A hospitals in China. A total of 818 subjects were observed. The whole clinical trial is managed by AI kunwei, a world-famous new drug R & D outsourcing service organization.
The results of a 36 week phase 3 clinical study showed that 'phase 9 and phase 1' could significantly improve cognitive impairment in patients with mild and moderate Alzheimer's disease. Compared with placebo group, the main efficacy index cognitive function improved significantly, and the score of cognitive function scale improved by 2.54 points (P & lt; 0.0001). The incidence of adverse events was similar to that of placebo group.
Geng Meiyu introduced that the preclinical mechanism of action shows that 'phase 9 and phase 1' can inhibit the abnormal increase of specific metabolites of intestinal flora, reduce peripheral and central inflammation and reduce & beta; Amyloid deposition and tau protein hyperphosphorylation improve cognitive impairment. This unique mechanism of targeting brain gut axis provides an important scientific basis for in-depth understanding of the clinical efficacy of 'phase 9 and phase 1'.