New drug for Alzheimer's disease completed Phase III trial

New drug for Alzheimer's disease completed Phase III trial

July 23, 2018 Source: Health News Author: Song Qiongfang a magic world, Hu Derong

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Recently, the new drug “Galome oligosaccharide” (GV-971), which was jointly developed by China Ocean University, Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Shanghai Pharmaceuticals, successfully completed the clinical phase III trial, which means that The development of this drug has taken the most critical step. Experts said that China's original innovative drugs are expected to be "blowout", and it is expected that by 2020, a number of major varieties can be "paid".

GV-971 is a marine oligosaccharide molecule extracted from seaweed. It is different from traditional targeted antibody drugs in that it can capture β-amyloid (Aβ) and inhibit Aβ fibril formation in multiple sites, multiple fragments and multiple states. The formed filaments are depolymerized into a non-toxic monomer. The clinical phase III trial of this drug is a randomized, double-blind, placebo-controlled study in China to evaluate the efficacy and safety of this drug in the treatment of patients with mild to moderate Alzheimer's disease. During the study period, patients were orally administered twice a day, 450 mg each, and cognitive changes were tested using the Alzheimer's Rating Scale 36 weeks later.

The results showed that GV-971 reached the expected level of improvement in cognitive function, with significant statistical significance and clinical significance. The incidence of adverse events was very similar to that of placebo, especially the toxic side effects of amyloid-associated imaging abnormalities often found in antibody drugs. According to doctors in charge of clinical trials, some patients have recovered from illiteracy to literacy and writing, and the effect is obvious.

The latest research also found that GV-971 reduces neurological inflammation in the brain by regulating intestinal flora imbalance and remodeling the body's immune homeostasis, preventing the progression of Alzheimer's disease. The person in charge of the R&D team introduced that the application for listing will be submitted to the State Drug Administration during the year.

According to experts, in recent years, a total of 168 new drug compounds in China have been in the third phase of clinical trials. According to the law of research and development, by 2020, it is expected to "pay" about 30 major varieties. Among the innovative drugs, the world's first or only one is not rare. For example, the EV71 hand, foot and mouth disease vaccine is the world's first vaccine against children's hand, foot and mouth disease; Ebola virus vaccine is also an independent intellectual property variety independently developed by China; there are four "Tini" drugs in the field of anti-tumor drugs. Among them, "furoquininib" has the potential to be the best inhibitor of the same type for the treatment of a variety of solid tumors.

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