On December 29, 2020, Green Valley Pharmaceuticals celebrated the 1^st Anniversary of GV-971 China Launch and 2^nd Gut-Brain Axis Forum in a virtual form, which was attended online by more than 3,000 experts, scholars and clinicians from across China. The event explored the pathogenesis of Alzheimer's disease (AD) from a brand-new perspective, providing new direction for AD treatment and research and bringing new hope to more patients and families.

At the forum, Professor Geng Meiyu, Academic Director General of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, who is also GV-971’s key inventor, shared her presentation titled Gut Microbiota and Complex Diseases: A New Concept in AD Research: “As gut microbes are known as the 'second genome' of human body, gut microbiota has a certain impact on the human immune system, enteroendocrine system, enteric nervous system, and metabolism. At present, the gut microbiota has gradually become a hot spot in the field of AD research.”

Photo: Professor Geng Meiyu

Geng added: “GV-971 (sodium oligomannate) is a new AD drug successfully approved after 22 years of research and development. In animal experiments to explore the drug’s mechanism of action, we found that it could recondition the gut microbiota in mouse models of AD and inhibit the abnormal increase of specific metabolites, thereby reducing peripheral and central inflammation. It could also inhibit the infiltration of peripheral inflammatory cytokines to the brain, ultimately reducing neuroinflammation and β-amyloid (Aβ) deposition in the brain. The already underway global Phase III clinical study will not only further validate GV-971’s gut-brain axis-based mechanism, but also provide new directions and inspirations for the development of new anti-AD drugs in the future.”

Also at the forum, Professor Luo Benyan, Director of the Neurology Department at the First Affiliated Hospital of Zhejiang University and Qiushi Distinguished Physician of Zhejiang University, presented her team's study on changes in the gut microbiota of AD patients and their correlation with cognitive impairment.

Photo: Professor Luo Benyan

“Over the past decade, there has been substantial evidence showing that gut microbes can modulate brain function,” noted Professor Luo Benyan. “Animal experiments have shown that gut microbiome dysbiosis is involved in a range of AD pathogenesis, including chronic neuroinflammation, oxidative stress, and neuroimmune and neuroendocrine abnormalities.”

In such a context, the study conducted by Professor Luo's team included three groups of subjects, namely the amnestic mild cognitive impairment group (aMCI, n=32), the Alzheimer's disease group (AD, n=33), and the control group (HC, n=32). “We carried out the study through collection of clinical data history, scale assessment, stool collection, and DNA extraction. Eventually, we found that the diversity of the gut microbiota in AD patients was significantly lower than that in aMCI patients and elderly controls of normal cognition, and AD patients were subject to a characteristic gut microbiota dysbiosis. Therefore, the gut microbiota (or the abundance of microbiota of specific changes) may be an important factor in the early diagnosis and treatment of AD.”

As the leading design instructor & chief scientist of GV-971’s global clinical study, Jeffrey Cummings, winner of the Bengt Winblad Lifetime Achievement Award (2018) from the IUS Alzheimer’s Association and Professor at the Cleveland Clinic Lou Ruvo Center for Brain Health, introduced the study’s design framework and research progress before the virtual forum wrapped up.

Photo: Professor Jeffrey Cummings

According to Cummings, the global clinical study coded “Green Memory” will be a 52-week, multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled, monotherapy study. By setting up about 200 clinical centers in 14 countries and regions including North America, Europe and China, it will enroll 2,046 patients with mild-to-moderate AD, half and half for both GV-971 and placebo groups. After the double-blind treatment period, a 26-week open-label period will also be conducted to investigate GV-971’s effects on the gut microbiome and explore the drug's potential in altering the course of disease.

Since GV-971’s China launch on December 29, 2019, the drug has to date served nearly 30,000 AD patients. With the patient enrollment process of the drug’s global multi-center Phase III clinical already in progress, it’s just a matter of time before AD patients around the world benefit from the China-developed novel drug.