On August 2, 2021, Sodium Oligomannate (GV-971), China’s novel drug for treating Alzheimer’s disease (AD), saw new progress for its global multi-center Phase III clinical trial – two patients, randomly enrolled from Xuanwu Hospital of Capital Medical University and Shanghai Mental Health Center, completed the trial’s first patient dosed in the Greater China region.
On May 20, a site initiation visit (SIV) was completed at Xuanwu Hospital of Capital Medical University, the global clinical trial’s first clinical site in China, signaling the formal commencement of GV-971 global multi-center Phase III clinical trial in Greater China. Coded “Green Memory”, the global clinical trial will span about 200 sites in 14 countries and regions across North America, Europe and Greater China for a 52-week double-blind trial and a 26-week open-label trial. It will involve 2,046 patients with mild-to-moderate AD, with 40% of them coming from Greater China.
Up to the end of July 2021, GV-971 global clinical trial has already initiated 88 clinical sites in the US, Canada, Australia, China and Czech Republic, completed screening of 464 patients, and randomly enrolled 105 of them.
“The global clinical trial will increase the proportion of patients with moderate-to-severe AD, and include new endpoints such as biomarkers and microbiota related to the disease course, including immunity, metabolism, and nerve damage in the blood. Therefore, we aim to further clarify GV-971’s potential in changing AD’s disease course, and further understand its long-term therapeutic effects through the trial.” Noted Professor Xiao Shifu from Shanghai Mental Health Center, a principal investigator of GV-971’s multi-center global Phase III clinical trial, at the Conference for Greater China Investigators.
Preclinical studies have revealed that GV-971, the first novel drug approved for treating AD globally in 17 years, has a brand-new mechanism of action on the gut-brain axis – this not only provides important scientific basis for deep understanding of the drug’s clinical efficacy, but also offers a new scientific perspective, guided by a holistic view, for research on the pathogenesis and treatment solution of chronic and complex diseases like AD. Preclinical studies have also shown that GV-971 can improve cognitive function by reshaping the balance of gastrointestinal microbiota and inhibiting the abnormal increase of specific metabolites of this gut microbiota, therefore reducing neuroinflammation. The drug can also directly bind with β-amyloid and reduce β-amyloid deposition in the brain.
Previously, GV-971’s China Phase III clinical trial was conducted in 34 Tier-1 hospitals across the country, and a total of 818 patients diagnosed with mild-to-moderate Alzheimer’s disease completed the drug trial. Results of the 36-week trial demonstrated that GV-971 had statistically improved cognitive function in patients with mild-to-moderate AD, with significantly improved primary efﬁcacy endpoints of cognitive function compared with the placebo group – the mean difference between GV-971 and placebo groups in ADAS-Cog12 Score (a standard cognitive measure commonly used in AD studies) was 2.54 (p< 0.0001). In addition, GV-971 was also safe and well tolerated with side effects comparable to the placebo. Based on GV-971’s mechanism of action and clinical trial data, Professor Jeffrey Cummings, a globally-renowned neurologist, commented that “GV-971 has the dual effect of both improving symptoms and potentially changing the disease course.”
For the global clinical trial, Green Valley continues to work with IQVIA, a world-famous CRO, for clinical trial operation, MedAvante for collection and evaluation of therapeutic indicators such as cognitive scales, and Q2sloution for analysis of biomarkers.
The 52-week double-blind global clinical trial is planned for completion by 2025, to be followed by new drug application (NDA) in Europe and the US, which will bring new hope for more AD patients around the world.