GV-971 Global Phase III Clinical Trial Completes First Patient Dosed Globally- Press Release-Green Valley

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GV-971 Global Phase III Clinical Trial Completes First Patient Dosed Globally

Date：2021-02-08

On February 3, 2021, Sodium Oligomannate (GV-971), China’s novel drug for treating Alzheimer’s disease (AD), announced first patient dosed globally in its global multi-center Phase III clinical trial which was in Clarity Clinical Research in the US.

So far, GV-971 global clinical trial has sequentially obtained approval from the US Food and Drug Administration as well as drug administrations in Canada, France, Chinese mainland and Taiwan, and has so far completed screening of 43 patients – after undergoing a series of evaluations, these patients from the US and Canada will be randomly enrolled in either the GV-971 or the placebo group for drug dosing. All subjects will need to satisfy the patient enrollment criteria of the global trial – they are patients with mild-to-moderate AD who score between 11 and 24 in MMSE (Mini-Mental State Examination). In addition, 75% of the enrolled patients will have a MMSE score of less than 20 and a medial temporal lobe atrophy (MTA) score of no less than 2, with no ischemic foci in white matter and no prior administration of other anti-AD drugs.

To date, more than 40 clinical sites in the US and Canada have completed the site initiation visit (SIV). North American investigator meeting will be hosted online on February 24 and 25 to discuss and exchange the relevant developments of GV-971 global clinical trial, after which meeting for European and Asian-Pacific investigators have also been successively scheduled.

GV-971 global multi-center Phase III clinical trial will involve a 52-week multicenter, randomized, double-blind, double-arm, placebo-controlled parallel-group, monotherapy clinical trial that are 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, with 40% coming from China, and 30% coming from North America and Europe respectively. After the 52-week double-blind treatment period, a 26-week open-label period will also be conducted to further verify GV-971’s clinical values.

“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 after enrolling the first patient, "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."

Previously, GV-971 China Phase III clinical trial was conducted in 34 Tier-1 hospitals across China, 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 mild-to-moderate AD patients, 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.

"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. " said 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, in a speech at the 13th Clinical Trials on Alzheimer's Disease conference.

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.

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