Green Valley reports NMPA approved Oligomannate for mild to moderate Alzheimer's disease 2

Green Valley reports NMPA approved Oligomannate for mild to moderate Alzheimer's disease

SHANGHAI, September 5 / PRNewswire / –

– Oligomannate, a new oral treatment for mild to
moderate Alzheimer's disease
– Alzheimer's Agent's Only World Approved Novel as of
2003 Shanghai Green Valley Pharmaceuticals (Green Valley) announced today that the Chinese National Medicines Administration (NMPA) oligominate (GV-971) has approved as a new drug to treat "mild to moderate Alzheimer's disease (AK) and improve cognitive function" .

NMPA granted Oligomannate an accelerated review in November 2018. It is the first new drug approved in the world since 2003 to treat Alzheimer's. Oligomannate offers patients a new treatment option to fight Alzheimer's, and it is expected to be available in China by the end of 2019.

Results of the study

Phase 3 clinical trial is more of a center, randomized, double-blind, placebo-controlled, parallel, 36-week study conducted by Beijing Union Hospital and the Shanghai Jiaotong University Mental Health Center. The study was conducted at 34 first-line hospitals across China. A total of 818 patients with a diagnosis of mild to moderate Alzheimer's disease participated in the study. The study was conducted in collaboration with IQVIA (formerly Quintiles) and Signat's Health (formerly Bracket).

The results of the study showed that Oligomannate statistically improved cognitive function in patients with mild to moderate AK within 4 weeks and maintained benefit at each follow-up visit. The mean difference between the oligomannate and placebo groups for ADAS-Cog12 (standard cognitive measurement method common in AK trials) was 2.54 (p

"I have studied Alzheimer's for 50 years, participated in several worldwide multicenter studies and have never experienced satisfactory treatment for Alzheimer's," said the professor. Zhang Zhenxin, one of the principal investigators of the Phase 3 study with Oligomannate and professor of neurology at Beijing Union Medical College Hospital in Beijing. "The outcome of the 9-month olimannat study is promising and we can finally see hope and a new beginning. I'm very happy for the patients and their families."

There are few drugs to treat Alzheimer's, and none can delay or prevent the progression of the disease, "said Professor Xiao Shifu, one of the leading investigators of a phase 3 oligomantat study at the Mental Health Center at Shanghai's Jiaotong Medical College." Phase 3 studies have shown a rapid onset of oligomannel activity within 4 weeks and further improvement in cognitive function in patients. Treatment was safe during the 36-week clinical trial. "

The cause of AK is still not fully understood. Deposition of amyloid plaques and neurofibrillary disorders is one of the suggested underlying etiologies; These are common goals of many current medicines to study. Oligomannate has a different mechanism of action than other medicines currently on the market and in clinical trials. As described by Professor Geng Meiyu, Principal Inventor of the drug at the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, preclinical studies show that oligonate restores intestinal microbiota dysbiosis, inhibits abnormal metabolism from the intestinal flora, modulates peripheral and central inflammation, which reduces amyloid deposition and hyperphosphorylation and enhances cognitive function.

Research Peak1 on Oligomannate's Pre-Clinical Study, recently published in Cell Research2, was written by Professor David M. Holtzman, Chair of the Department of Neurology and director of the Hope Center for Hope at the University of Washington at St. John's. To Louis and his colleagues that preclinical data "support the emerging notion that modulation of the gut microbiota should be further investigated by treatments such as GV-971 or other strategies as new strategies to slow the progression of AK."

Green Valley will soon introduce Oligomannate in China and plans to file regulatory filings in select countries after its introduction. A Phase 3 (GREEN HELP) Global Study with locations in the US, Europe and Asia is scheduled to be launched in early 2020 to support Oligomannate's global approval.

"The China-led Phase 3 clinical trial has shown lasting cognitive benefits and is well tolerated, making it the first new treatment for Alzheimer's approved in many years. We welcome this innovation," said Dr. Sc. Jeffrey Cummings, vice president of research and research, professor at UNLV's Department of Brain Health, and professor and director of the Clinical Center for Neurodegeneration and Translational Neuroscience in Cleveland, a Center for Brain Health and a Green Valley Scientific Advisor. "We look forward to a global Phase 3 trial of olilignanate that will investigate its clinical impact on a larger and more diverse population and collect samples demonstrating the biological effects of the drug.

"They are encouraged by the improvement in cognitive performance, safety and tolerability achieved by the oligommanate in this first clinical trial and the potential to diversify the portfolio of promising therapies for our patients and families," said Dr. Sc. Eric Reiman, Director of the Banner Alzheimer Institute and Green Valley Scientific Advisor. "In addition, I am encouraged by the plan to further explore the clinical and biological implications of this drug in global trials."

"The preclinical observation that oligomannate suppresses intestinal dysbiosis and uses neuroinflammation has led to improvements in cognitive impairment, as demonstrated by test results. Med. Philip Scheltens, professor of neurology and CEO of the Alzheimer Center Amsterdam and Green Valley scientific adviser." These findings deepen our understanding of the mechanisms involved in Alzheimer's disease and suggest that the gut microbiota is a valid target for the development of AK therapy. "

"We are delighted that Oligomannate is the first new drug approved to treat Alzheimer's for 17 years and we are grateful to our patients and families who are the true heroes in the fight against this debilitating disease," said Mr. Lv Songtao, CEO of Green Valley. "At Green Valley, we are committed to developing drugs that meet the greatest unmet medical need for human health," and finally, after 22 years of persistent effort, we have succeeded. We look forward to continuing to offer new treatment to all patients worldwide.

About the Green Valley

Shanghai Green Valley Pharmaceuticals is an innovative Chinese pharmaceutical company developing new strategies for treating chronic and complex diseases. The company is committed to the task of "developing drugs that meet the greatest unmet medical need for human health", examines the pathogenesis of chronic and complex diseases with a holistic approach to treatment, and focuses on advanced innovations in the research and development of carbohydrates as drugs. Green Valley's mission is to become a world leader in innovative carbohydrates by providing safer and more effective medicines for patients with chronic and complex illnesses, making better treatment choices and improving quality of life.

Green Valley Pharmaceuticals was founded in 1997 and is headquartered in Zhangjiang Science City, Shanghai, China. The focus is on the promotion of research programs on neuropsychiatric diseases, cancer, cardiovascular diseases, metabolic diseases and autoimmune diseases. The company employs 1,500 people in China and has a US subsidiary. It has built the world’s first large carbohydrate library, the first carbohydrate drug discovery and processing facility, and the world’s leading carbohydrate drug discovery and development pipeline.

Alzheimer's disease data

Alzheimer's disease is a progressive brain disorder characterized by cognitive and behavioral impairments that significantly affect daily activities. It is the third most common cause of disability and death in the elderly, along with cardiovascular disease and cancer. According to Alzheimer International, there are about 50 million people with dementia worldwide, about two-thirds of whom have Alzheimer's disease; the annual medical cost of the disease is estimated at more than $ 3 trillion.

Statements for the future

This press release may contain forward-looking statements based on Green Valley's current assumptions and forecasts. There are numerous known and unknown risks, uncertainties and other factors that may cause a material difference compared to the actual future results, financial situation, development or impact of Green Valley and the estimates provided. These factors include those described in the Green Valley Public Reports, which are available on the Green Valley website at http://www.shgvp.com/En. Green Valley assumes no responsibility for updating these statements in the future or for consistency with those statements and future events or developments.

letter of credit

1. Seo DO (https://www.ncbi.nlm.nih.gov/pubmed/?term=Seo%20DO%5BAutho
r% 5D & cauthor = true & cauthor_uid = 31488883, Boros BD (https: //www.ncb
i.nlm.nih.gov/pubmed/?term=Boros%20BD%5BAuthor%5D&cauthor=true&cau
thor_uid = 31488883) and Holtzman DM (https://www.ncbi.nlm.nih.gov/
PubMed /? Dates = Holtzman% 20DM% 5BAuthor% 5D-cauthor = true & cauthor_uid = 31
488883) (2019) Microbiome: Aim for Alzheimer's?
(Microbiome: Aim for Alzheimer's?) Cellular incision.
(https://www.ncbi.nlm.nih.gov/pubmed/31488883) 29 (10): 779-780
2. Wang X and Sun G et. Dr. (2019) Sodium oligomannate
therapeutically reconstructs the microbiota well and suppresses it well
inhibit bacterial amino acids in the form of inhibition
Alzheimer's disease progression (Sodium oligomannate modeled
therapeutic gut microbiota and suppress bacteria
Non-threatening amino acid-to-intestine bowel
Progression of Alzheimer's.) Cell Res.
29 (10): 787-803
3rd World Alzheimer Report 2018,
published by Alzheimer's Disease International (ADI),
London, 2018

Jinhe Li
jinhe.li@shgvp.com
+1 847-899-3587

Original content: Shanghai Green Valley Pharmaceuticals, news actuell reports
Original message: https://www.presseportal.de/pm/137804/4422053