Shanghai Green Valley Pharmaceutical Co., Ltd. announced on the 17th that the new drug for the treatment of Alzheimer's disease, "Ganlu oligosaccharide (GV-971)", was successfully completed by China Ocean University, Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Shanghai Lugu Pharmaceutical. Clinical phase 3 trial. The completion of the trial means that the new drug development has taken the most critical step.

Alzheimer's disease, commonly known as Alzheimer's disease, is characterized by progressive loss of cognitive function in the brain. According to the International Alzheimer's Association, there are currently approximately 48 million patients worldwide.

The Phase 3 trial of GV-971 is a randomized, double-blind, placebo-controlled, 36-week study in China to evaluate GV-971 in patients with mild to moderate Alzheimer's disease Table scores are 11-26) for effectiveness and safety. During the clinical study, the patient took oral medication 450 mg/time twice daily. The primary efficacy endpoint was the change in the cognitive component of the Alzheimer's Rating Scale after 36 weeks of treatment. 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.

The drug is a marine oligosaccharide molecule extracted from seaweed. Unlike traditional targeted antibody drugs, GV-971 can capture β-amyloid (Aβ) in multiple sites, multiple fragments and multiple states, inhibit the formation of Aβ fibrils, and depolymerize the formed filaments into non-toxic monomers. . The latest research found that GV-971 also 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.

According to the person in charge of the R&D team, the positive result of GV-971 clinical phase 3 is the crystallization of the team's 21 years of hard work. The early research and development originated from China Haida, and further in-depth research and development was completed by Shanghai Pharmaceutical Research Institute and Green Valley Pharmaceutical. GV-971's novel mode of action and unique multi-target action characteristics have opened up a new path for drug development in Alzheimer's disease, and are expected to lead a new wave of research and development of carbohydrate drugs, and to enhance the international status of innovative drug research in China. Far-reaching significance.

It is reported that Shanghai Green Valley Pharmaceuticals will submit the GV-971 marketing application license for the treatment of mild to moderate Alzheimer's disease to the State Drug Administration during the year.

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