Green Valley Announces NMPA Approval Of Oligomannate For Mild To Moderate Alzheimer's Disease - Seite 2

"There are only few drugs available to treat Alzheimer's disease, and none can delay or prevent progression of the disease," said Professor Xiao Shifu, a leading principal investigator of the phase 3 trial of Oligomannate at Center for Mental Health at Shanghai Jiaotong University Medical College. "The results of the Phase 3 clinical study showed rapid onset of efficacy of Oligomannate within 4 weeks, and that patients' cognitive function continued to improve. The treatment was safe during the 36-week clinical trial."

The cause of AD is not yet fully understood. Deposition of amyloid plaques and neurofibrillary tangles are among the proposed underlying etiologies; these are the common targets of many current investigational drugs.  Oligomannate has a mechanism of action distinct from other agents currently on the market and in clinical trials.  As described by Professor Geng Meiyu, the 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.

In the Research Highlight¹ about the preclinical study of Oligomannate recently published in Cell Research², Professor David M. Holtzman, chairmen 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 further explored as novel strategies to slow the progression of AD".

Green Valley will launch Oligomannate very soon in China, and plan to submit the marketing authorization applications in selected countries following the China launch.  A multi-center global phase 3 clinical trial (GREEN MEMORY) with sites in the U.S., Europe and Asia is planned to be initiated in early 2020 to support global regulatory filing of Oligomannate.

"The phase 3 clinical trial of Oligomannate conducted in China showed a sustainable cognitive benefit. It was well tolerated. This is the first new therapy for Alzheimer's disease approved in many years and we applaud this innovation," said Jeffrey Cummings, MD, Vice Chair for Research and Research Professor of UNLV Department of Brain Health and Professor and director of Center for Neurodegeneration and Translational Neuroscience Cleveland Clinic, Lou Ruvo Center for Brain Health, and a scientific advisor to Green Valley. "We look forward to the global phase 3 trial of Oligomannate to investigate its clinical effects in larger and more diverse populations and to collect samples that will provide evidence of the agent's biological effects.