Green Valley Obtains IND Approval from U.S. FDA for Sodium Oligomannate's International, Phase III Clinical Study
PR83819
SHANGHAI, April 27, 2020 /PRNewswire=KYODO JBN/ --
On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the
formal decision letter from the US Food and Drug Administration (FDA) on the
Investigational New Drug (IND) application for the GV-971 international
multi-center Phase III clinical study. The letter indicated the "Study May
Proceed" with the proposed clinical investigation in the treatment of patients
with Alzheimer's disease, and the IND effective date is April 3, 2020.
GV-971 is an orally administered mixture of acidic linear oligosaccharides
derived from marine brown algae. Preclinical studies on its mechanism of action
shows that GV-971 can improve cognitive function by reshaping the balance of
gastrointestinal microbiota, inhibiting the abnormal increase of specific
metabolites of this gut microbiota, reducing peripheral and central
inflammation, Beta-amyloid deposition and hyperphosphorylation of Tau protein.
A growing body of evidence reveals that gut microbiota is highly correlated
with the incidence of Parkinson's disease, depression, autism and other central
nervous system diseases. GV-971 obtained conditional approval from China NMPA
for improving the cognitive function of patients living with mild to moderate
Alzheimer's disease on November 2, 2019, and launched in China on December 29,
2019.
Based on the full data package of GV-971 nonclinical, clinical, chemistry,
manufacturing and control (CMC), and the China Phase III clinical efficacy and
safety outcomes used for the NDA approval by the China NMPA, Green Valley
submitted the IND application to the FDA directly for an international
multi-center Phase III clinical trial and obtained approval, which will shorten
the overall process to bring the new hope to patients suffering from
Alzheimer's disease worldwide.
Green Valley will continue to work with IQVIA (formerly known as Quntile), the
world's largest contract research organization (CRO) for clinical trial
operation, to manage the Phase III clinical trial of GV-971. The study, which
plans to enroll more than 2000 patients with mild to moderate Alzheimer 's
disease, and comprises of a 12-month double-blind treatment period and a
6-month open-label period, will be conducted at 200 sites in North America,
Europe, and Asia-Pacific regions including China. Jeffrey Cummings, the winner
of the Bengt Winblad Lifetime Achievement Award (2018) from National
Alzheimer's Association of America and Professor of Neurotherapeutics and Drug
Development in the Neurological Institute, Cleveland Clinic, has been leading
the clinical trial design and will serve as the Chairman of Scientific
Innovation Committee (SIC) for Green Valley. Leading principal investigators
(PI) include Martin Farlow, Roy Jones, Bruno Vellas and other world-renowned
experts. The leading PIs in China are Professor Jia Jianping of Xuanwu Hospital
of Capital Medical University and Professor Xiao Shifu of Shanghai Mental
Health Center.
The phase III clinical trial is planned to be completed in 2024, and the new
drug registration application (NDA) submission is expected by 2025.
Source: Shanghai Green Valley Pharmaceuticals
本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。
このプレスリリースには、報道機関向けの情報があります。
プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。