On November 4, 2021, it was revealed at the 13th Clinical Trials on Alzheimer's Disease conference (CTAD) that GV-971 (Sodium Oligomannate) developed by Green Valley Pharmaceuticals, China’s novel drug for treating Alzheimer’s disease (AD) and one of Shanghai’s high-tech innovation achievements, has officially kicked off the patient enrollment process for its global multi-center Phase III clinical Trial. So far, the study’s first patient screening in the world has been successfully completed, signaling the official start of GV-971’s internationalization journey that will benefit AD patients worldwide with the novel drug from China.
In the opening day at the CTAD conference, Jeffrey Cummings, winner of the Bengt Winblad Lifetime Achievement Award 2018 from National Alzheimer’s Association of America and Professor of Brain Science at the University of Nevada Las Vegas, the chairman of Scientific Innovation Committee for Green Valley, scientific lead for the GV-971 global phase III clinical trial, delivered an online presentation to share the study’s various elements such as framework design and study progress with scientists and researchers around the world..
He stated that GV-971’s global clinical trial had already completed its first patient screening at Clarity Clinical Research in the US. He also revealed that 40% of the trial’s enrolled patients would come from China, and 30% from North America and Europe respectively. The study plans to enroll one-fifth of its subjects in the next six months.
According to Professor Cummings, GV-971 global clinical study, coded “Green Memory”, will involve a 52-week multicenter, randomized, double-blind, double-arm, placebo-controlled parallel-group, monotherapy clinical trial that is to be conducted at about 200 sites in 14 countries and regions across 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 further verify GV-971’s clinical values.
Different from the primary efﬁcacy endpoints of GV-971 China Phase III clinical trial, its global clinical trial will not only collect the ADAS-Cog12 score, but also include the ADCS-CGIC score in the primary efﬁcacy endpoints. At the same time, its secondary efﬁcacy endpoints will also include the MMSE score, the NPI score and the ACDS score.
Professor Cummings said, “The point is for clinical measures to confirm the cognitive effect, determine the breadth of the effects, understand the duration of the effect of GV-971 in the global phase-three trial compared to the Chinese phase-three trial. Biomarker outcomes will include the blood Aβ 42/40 ratio, blood p-tau, and others to interrogate the effects of GV-971 on the microbiome and to explore the disease modifying potential of GV-971.”
“Recently, there has been a lot of interest in the gut brain connection for Parkinson's. And Parkinson's has a somewhat similar dementia to Alzheimer’s, as far as the effect. And there are also some studies on the gut brain connection for Alzheimer's." Dr. Hafner, PI of Clarity Clinical Research for GV-971 global phase III clinical trial, said, "Your studies are very promising. You have good data. The drug was approved in China. And it's something that I would like to be a part of. It's about time we expand our thought on the disease of Alzheimer's and its treatment."
For GV-971 global clinical trial, Green Valley continues to work with IQVIA, the world’s largest CRO firm, 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 international clinical study is planned for completion by 2025, to be followed by new drug application (NDA) in the US and Europe.