Shanghai China’s Green Valley Pharmaceuticals (Green Valley) received approval from the China National Medical Products Administration (NMPA) for their Oligomannate (GV-971) as a new drug for the treatment of mild to moderate Alzheimer’s disease (AD) and improving cognitive function.
As noted in Green Valley’s press release, NMPA granted Oligomannate for fast-track review in November. This represents the first novel drug approved globally since 2003 according to the Chinese commercial sponsor. It is expected to be available in China in early 2020.
The approval was based on a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study led by Peking Union and Shanghai Jiaotong University Medical School Mental Health Center. Conducted in 34 Tier-1 hospitals across China, a total of 818 patients participated in the study which was supported by CRO services (IQVIA) and packaged technical services (Signant Health) among other partners.
The trial results revealed that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit. The mean difference between Oligomannate and the placebo groups in the ADAS-Cog12 score (a standard cognitive measure used in AD studies) was 2.54 (p<0.0001), with sustained efficacy from the first month of treatment to the end of 9 months of treatment. The sponsor reports that the drug was safe and well-tolerated with side effects comparable to the placebo arms.
A Strong Statement from Principal Investigators
Professor Zhang Zhenxin, MD, the principal investigator of the Phase III trial (and professor of Neurology at Peking Union Medical College Hospital, Beijing) reports “I have been doing research on Alzheimer’s disease for 50 years, participated in multiple global multi-center studies of multiple drugs, and had never found a satisfactory treatment for Alzheimer’s disease.” He continued “The result of the 9-month trial of Oligomannate is exciting. We finally see hope and the dawn. I am sincerely happy for the patients and their families.”
Professor Xiao Shifu, leading principal investigator of the Phase III trial at Center for Mental Health at Shanghai Jiaotong University Medical College noted:” There are only few drugs available to treat Alzheimer’s disease, and none can delay or prevent progression of the disease.” He emphasized “The results of the Phase III clinical study showed rapid onset of efficacy of Oligommanate within 4 weeks, and that patients’ cognitive function continued to improve. The treatment was safe during the 36-week clinical trial.”
What is Oligommanate?
Green Valley Pharmaceuticals posits that Oligomannate has a mechanism of action distinct from other agents currently under study in clinical trials. As described by Professor Geng Meiyu, a leading inventor of the drug at the Chinese Academy of Sciences Shanghai Institute of Materia Medica, the preclinical studies show that Oligomannate reconditions dysbiosis of gut microbiota, inhibits the abnormal increase of intestinal flora metabolites, modulates peripheral and central inflammation, reduces amyloid protein deposition and tau hyperphosphorylation, and improves cognitive function.
Professor David M. Holtzman, chairman of Department of Neurology and director of Hope Center for Neurological Diseases at Washington University in St. Louis and his colleagues wrote that the preclinical data “supports the emerging idea that modulation of the gut microbiome via treatments such as GV-971 or other strategies should be explored as novel strategies to slow the progression of AD.”
Product Launch in China
Green Valley will launch the treatment in China soon now that it has been approved by the authorities there. They will submit marketing authorization applications in select countries following the China launch.
Coming to America
Moreover, Green Valley is running the “Green Memory” multi-center global Phase III clinical trial with sites in the U.S., Europe, and Asia starting in early 2020 to support the global regulatory filing of Oligomannate.
Who is Green Valley
Shanghai Green Valley Pharmaceuticals is an innovative Chinese pharmaceutical company that pioneers new treatment strategies in the area of chronic and complex diseases. The company seeks to target unmet needs for human health by exploring the pathogenesis of chronic and complex diseases with a holistic view of treatment and focuses on breakthrough innovation in research and development of carbohydrate drugs.
Founded in 1997, it is headquartered in Zhangjiang Science City, Shanghai China. The emerging company focuses on advancing research programs in neuropsychiatric diseases, cancer, cardiovascular diseases, metabolic diseases, and autoimmune diseases. With 1,500 employees in China and a subsidiary in America, it has built the world’s first large-scale carbohydrate compound library, the first carbohydrate drug API and processing facility and the world’s leading R&D pipeline for carbohydrate drug products.
Lead Research/Investigators for the Phase III Chinese Study
Professor Zhang Zhenxin, MD, the principal investigator of the Phase III trial (and professor of Neurology at Peking Union Medical College Hospital, Beijing
Professor Xiao Shifu, Leading Principal Investigator of the Phase III trial at Center for Mental Health at Shanghai Jiaotong University Medical College
Call to Action: TrialSite News will monitor the usage in China as well as the forthcoming Phase III trial.