[Translation] A 36-week, multicenter, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of Ganluten Sodium Capsules (GV971) in the treatment of mild and moderate Alzheimer's disease

主要目的：验证甘露特钠（GV-971）治疗轻、中度阿尔茨海默病 36 周对改善认知功能、日常生活功能的有效性。其他目的：评价甘露特钠（GV-971）对整体临床印象、日常生活功能和精神行为症状的疗效，验证其可能的作用机制，并同时观察其安全性。

[Translation]

Main purpose: To verify the effectiveness of sodium mannitol (GV-971) in treating mild and moderate Alzheimer's disease for 36 weeks in improving cognitive function and daily life function. Other purposes: To evaluate the efficacy of sodium mannitol (GV-971) on overall clinical impression, daily life function and psychiatric and behavioral symptoms, verify its possible mechanism of action, and observe its safety at the same time.

Start Date20 Sep 2023

Sponsor / Collaborator

Ocean University of China

[+2]

NCT05908695 / RecruitingPhase 4

A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease

The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.

Start Date31 Aug 2023

Sponsor / Collaborator

Shanghai Green Valley Pharmaceutical Co., Ltd.

100 Clinical Results associated with Sodium Oligomannurarate

100 Translational Medicine associated with Sodium Oligomannurarate

100 Patents (Medical) associated with Sodium Oligomannurarate

Literatures (Medical) associated with Sodium Oligomannurarate

01 Sep 2024·Biosensors and Bioelectronics

Strategies for measuring concentrations and forms of amyloid-β peptides

Review

Author: Kong, Fangong ; Shen, Hangyu ; Liu, Keyin ; Ren, Mingguang ; Wang, Xiaoying ; Wang, Shoujuan

Alzheimer's disease (AD) is affecting more and more people worldwide without the effective treatment, while the existed pathological mechanism has been confirmed barely useful in the treatment. Amyloid-β peptide (Aβ), a main component of senile plaque, is regarded as the most promising target in AD treatment. Aβ clearance from AD brain seems to be a reliably therapeutic strategy, as the two exited drugs, GV-971 and aducanumab, are both developed based on it. However, doubt still exists. To exhaustive expound on the pathological mechanism of Aβ, rigorous analyses on the concentrations and aggregation forms are essential. Thus, it is attracting broad attention these years. However, most of the sensors have not been used in pathological studies, as the lack of the bridge between analytical chemist and pathologists. In this review, we made a brief introduce on Aβ-related pathological mechanism included in β-amyloid hypothesis to elucidate the detection conditions of sensor methods. Furthermore, a summary of the sensor methods was made, which were based on Aβ concentrations and form detections that have been developed in the past 10 years. As the greatest number of the sensors were built on fluorescent spectroscopy, electrochemistry, and Roman spectroscopy, detailed elucidation on them was made. Notably, the aggregation process is another important factor in revealing the progress of AD and developing the treatment methods, so the sensors on monitoring Aβ aggregation processes were also summarized.

01 Sep 2024·Acta Pharmacologica Sinica

Sodium oligomannate activates the enteroendocrine-vagal afferent pathways in APP/PS1 mice

Article

Author: Gong, Hua-Shan ; Wu, Mei-Mei ; Guo, Fei ; Dong, Li ; Pan, Jing-Pei ; Rong, Wei-Fang ; Li, Yang

Enteroendocrine cells (EECs) and vagal afferent neurons constitute functional sensory units of the gut, which have been implicated in bottom-up modulation of brain functions. Sodium oligomannate (GV-971) has been shown to improve cognitive functions in murine models of Alzheimer's disease (AD) and recently approved for the treatment of AD patients in China. In this study, we explored whether activation of the EECs-vagal afferent pathways was involved in the therapeutic effects of GV-971. We found that an enteroendocrine cell line RIN-14B displayed spontaneous calcium oscillations due to TRPA1-mediated calcium entry; perfusion of GV-971 (50, 100 mg/L) concentration-dependently enhanced the calcium oscillations in EECs. In ex vivo murine jejunum preparation, intraluminal infusion of GV-971 (500 mg/L) significantly increased the spontaneous and distension-induced discharge rate of the vagal afferent nerves. In wild-type mice, administration of GV-971 (100 mg· kg^-1 ·d^-1, i.g. for 7 days) significantly elevated serum serotonin and CCK levels and increased jejunal afferent nerve activity. In 7-month-old APP/PS1 mice, administration of GV-971 for 12 weeks significantly increased jejunal afferent nerve activity and improved the cognitive deficits in behavioral tests. Sweet taste receptor inhibitor Lactisole (0.5 mM) and the TRPA1 channel blocker HC-030031 (10 µM) negated the effects of GV-971 on calcium oscillations in RIN-14B cells as well as on jejunal afferent nerve activity. In APP/PS1 mice, co-administration of Lactisole (30 mg ·kg^-1 ·d^-1, i.g. for 12 weeks) attenuated the effects of GV-971 on serum serotonin and CCK levels, vagal afferent firing, and cognitive behaviors. We conclude that GV-971 activates sweet taste receptors and TRPA1, either directly or indirectly, to enhance calcium entry in enteroendocrine cells, resulting in increased CCK and 5-HT release and consequent increase of vagal afferent activity. GV-971 might activate the EECs-vagal afferent pathways to modulate cognitive functions.

15 Aug 2024·Biology of Reproduction

Sodium oligomannate’s amelioration of reproductive and metabolic phenotypes in a letrozole-induced PCOS-like mouse model depends on the gut microbiome

Article

Author: Zhang, Feifei ; Liu, Haiou ; Bai, Yixuan ; Cai, Qingqing ; Li, Zhi ; Liu, Yan ; Wang, Yuhui ; Xu, Congjian ; Wang, Yang

AbstractIt has been well established that there is a connection between polycystic ovary syndrome pathology and gut microbiome dysbiosis. A marine-derived oligosaccharide, GV-971, has been reported to alter gut microbiota and alleviate Aβ amyloidosis. In this study, the effects of GV-971 on polycystic ovary syndrome–like mice were explored. Mice were randomly assigned into four groups: control, letrozole, letrozole + GV-971, and control + GV-971. Glucose metabolism in polycystic ovary syndrome–like mice was ameliorated by GV-971, while the reproductive endocrine disorder of polycystic ovary syndrome–like mice was partially reversed. The messenger ribonucleic acid levels of steroidogenic enzymes in ovaries of polycystic ovary syndrome–like mice were improved. GV-971 restored the fertility of polycystic ovary syndrome–like mice and significantly increase the number of litters. Furthermore, GV-971 treatment effectively mitigated abnormal bile acid metabolism. Notably, after GV-971 intervention, gut microbiota alpha-diversity was considerably raised and the relative abundance of Firmicutes was reduced. In conclusion, the hyperinsulinemia and hyperandrogenemia of polycystic ovary syndrome–like mice were alleviated by GV-971 intervention, which was associated with mitigating bile acid metabolism and modulating gut microbiota.

News (Medical) associated with Sodium Oligomannurarate

20 Dec 2022

·www.businesswire.com

World Alzheimer's Disease Therapeutics Analysis Report 2022: 101 Active Drugs - Market Insight, Epidemiology and Pipeline Assessment by Molecule Type, Route of Administration, Pipeline Phase - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Alzheimer's Disease Therapeutics (2022 Edition) - Market Insight, Epidemiology and Pipeline Assessment (By Molecule Type, By Route of Administration, By Pipeline Phase)" report has been added to ResearchAndMarkets.com's offering. Alzheimer's disease Therapeutics Pipeline Analysis has 101 active drugs undergoing several stages of clinical trials. The Alzheimer's disease Therapeutics Pipeline is driven by an increasing gap of unmet need of effective therapeutics that can cure Alzheimer's disease. Additionally, life expectancy has increased due to various healthcare reforms in major economies such as the U.S., Japan, and China. This has resulted in a large geriatric population which is the age group most affected by the disease. Alzheimer's prevalence is rising rapidly and despite decades of research, the disease remains incurable. The majority of therapeutics target symptom reduction and slowing the progression of the disease. The Food and Drug Administration (FDA) approved aducanumab (Aduhelm) for the treatment of certain cases of Alzheimer's disease in June 2021 and this is the first drug approved for Alzheimer's disease in decades. Eisai, Biogen, Hoffmann-La Roche, AZTherapies, Cerecin, Neurotrope, AC Immune, Cassava Sciences, AB Science, Anavex Life Sciences, Athira Pharma, Denali Therapeutics Inc., and other notable companies are developing therapeutic candidates to improve the Alzheimer's Diagnosis and treatment scenario. Scope of the Report The report analyses the Alzheimer's Disease Therapeutics in Pipeline by Molecule Type (Small Molecules, Monoclonal Antibody, Vaccine, DNA/RNA Based, Natural products, Gene Therapy, Cell Therapy, Others). The report analyses the Alzheimer's disease Therapeutics by Route of Administration (Oral, Intravenous, Intramuscular, Subcutaneous, Intrathecal, Intranasal, Other). The report analyses the Alzheimer's disease Therapeutics by Pipeline Phase (Phase I, Phase I/II, Phase II, Phase II/III, Phase III, Phase IV, Preclinical). The report analyses the Pain Management Drugs Market by Availability (Over the Counter (OTC), Prescription). The Alzheimer's Disease Therapeutics Pipeline Analysis has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The Global Pain Management Drugs Market has been analysed By Region (Americas, Europe, Asia Pacific, and MEA). The key insights of the report have been presented through the leading company shares. Also, the major, trends, drivers and challenges as well as Unmet Needs of the industry has been analysed in the report. The companies analysed in the report include Eli-Lily & Co , Elsal Co., Ltd., BioVie, Johnson and Johnson, Otsuka Pharmaceutical Co., Ltd. H. Lundbeck A/S, Novartis, Cognition Therapeutics, Merck Sharp & Dohme LLC, Biogen. Key Target Audience Alzheimer's Disease Therapeutics Companies End Users (Hospitals and clinics) Research and Development (R&D) Organizations Government Bodies & Regulating Authorities Investment Banks and Equity Firms Key Topics Covered: 1. Introduction 1.1 Alzheimer's Disease Therapeutics Overview 1.2 Scope of Research 2. Executive Summary 2.1 Market Dashboard 2.2 Regional Insights 2.3 Market Ecosystem Factors 3. Research Methodology 3.1 Data Collection Process 3.2 Market Size Calculation-Top-to-Bottom 4. Macro Economic Indicator Outlook 4.1 Global, Region wise GDP Growth 4.2 Global Medical Spending 4.3 Current Healthcare Expenditure 4.4 Pharmaceutical Spending/capita 5. Competitive Positioning 5.1 Companies' Product Positioning 5.2 Competitive positioning 5.2.1 Eli-Lily & Co 5.2.2 Elsal Co., Ltd. 5.2.3 BioVie 5.2.4 Johnson & Johnson 5.2.5 Otsuka Pharmaceutical Co., Ltd. 5.2.6 H. Lundbeck A/S 5.2.7 Novartis 5.2.8 Cognition Therapeutics 5.2.9 Merck Sharp & Dohme LLC 5.2.10 Biogen 6. Alzheimer's disease background 6.1 AD Fact Sheet 6.2 Epidemiology 6.3 Causes and Risk Factors 6.4 Diagnosis and Assessment 6.5 Unmet Needs 7. Therapeutics in Pipeline 7.1 Pipeline Scenario 7.2 Alzheimer's Therapeutics Comparative Review 8. Pipeline Analysis 9. Phase I therapeutics Overview 9.1 LY3372993 9.1.1 Drug Description 9.1.2 Outcomes 9.2 Lu AF87908 9.3 anle138b 9.4 ASN51 9.5 CMS121 9.6 IBC-Ab002 9.7 LX1001 9.8 MK-2214 9.9 MK-8189 9.10 ACU193 9.11 NIO752 9.12 ALN-APP 9.13 TB006 9.14 SNK01 9.15 Pepinemab 9.16 GB-5001 9.17 AC-1202 9.18 SHR-1707 9.19 BEY2153 9.20 JNJ-40346527 9.21 APNmAb005 9.22 NPT 2042 9.23 ALZ-101 10. Phase I/II therapeutics Overview 10.1 Posiphen 10.1.1 Drug Description 10.1.2 Outcomes 10.1.3 Collaborators 10.2 PrimeProT/ PrimeMSKT 10.3 TB006 10.4 RO7126209 10.5 DNL593 10.6 BIIB080 10.7 E2814 10.8 Tdap 10.9 ACI-35.030/ JACI-35.054 10.10 ACI-24.060 10.11 IVL3003 11. Phase II therapeutics Overview 11.1 Lecanemab 11.1.1 Drug Description 11.1.2 Outcomes 11.1.3 Collaborators 11.2 Lomecel-B 11.3 AL002 11.4 AL001 11.5 CT1812 (Elaya) 11.6 APH-1105 11.7 ATH-1017 11.8 T-817MA 11.9 Montelukast buccal film 11.10 ABBV-916 11.11 Bepranemab 11.12 TB006 11.13 LY3372689 11.14 MW150 11.15 EX039 11.16 JNJ-42847922 11.17 REM0046127 11.18 Bryostatin 1 11.19 NanoLithium NP03 11.20 AstroStem 11.21 Gantenerumab 11.22 Semorinemab 11.23 Obicetrapib 11.24 ALZ-801 11.25 CY6463 11.26 Crenezumab 11.27 T3D-959 11.28 PMZ-1620 11.29 GV1001 11.30 ACZ885 11.31 PQ912 11.32 APH-1105 11.33 SLS-005 11.34 Flos gossypii flavonoids 11.35 Human Mesenchymal Stem cells (MSCs) 11.36 JNJ-63733657 11.37 IGC-AD1 11.38 TW001 11.39 ABvac40 12. Phase II/III therapeutics Overview 12.1 Tricaprilin 12.1.1 Drug Description 12.1.2 Outcomes 12.2 ANAVEX2-73 12.3 Piromelatine 12.4 AGB101 13. Phase III therapeutics Overview 13.1 Simufilam 13.1.1 Drug Description 13.1.2 Outcomes 13.1.3 Collaborators 13.2 ATH-1017 13.3 Lecanemab 13.4 Nilotinib BE 13.5 Brexpiprazole 13.6 Masitinib 13.7 Remternetug 13.8 Donanemab 13.9 NE3107 13.10 Gantenerumab 13.11 GV-971 13.12 Aducanumab 13.13 TRx0237 13.14 Semagludtide 13.15 BPDO-1603 13.16 AR1001 13.17 KarXT 13.18 AXS-05 14. Phase IV therapeutics Overview 14.1 Choline Alfoscerate 14.1.1 Drug Description 14.1.2 Outcomes 14.2 Ebicomb 14.3 Rivastigmine 14.4 GV-971 15. Preclinical Phase therapeutics Overview 15.1 PMN310 15.1.1 Drug Description 15.1.2 Outcomes 15.1.3 Collaborators 15.2 PRX123 16. Pipeline analysis, By molecule type 16.1 Alzheimer's Therapeutics Comparative Review, by Molecule type 17. Pipeline analysis, By Route of Administration 17.1 Alzheimer's Therapeutics Comparative Review, By Route of Administration For more information about this report visit https://www.researchandmarkets.com/r/wcw7f7

Drug ApprovalPhase 2Phase 1

11 May 2022

·endpts.com

Scoop: Green Valley's seaweed-derived Alzheimer's drug, approved in China, is halted in PhIII study

A Phase III study of a seaweed-derived Alzheimer’s drug, conditionally approved in China in November 2019, has been halted, five trial sites have confirmed to Endpoints News. Shanghai-based Green Valley Pharmaceuticals’ oligomannate, or GV-971, was in a late-stage Alzheimer’s study dubbed “Green Memory,” but the trial was halted due to supply chain issues, according to four of the sites. One site said it was not supply chain-related. Eric Reiman, a former scientific advisor to Green Valley, said he was informed the trial was discontinued “due to unexpected financial challenges related to the COVID-19 Pandemic in China.” “Based on the information that was shared with us, the advisors were not aware of any treatment-related safety issues,” Reiman said in an email to Endpoints. He is also executive director of Banner Alzheimer’s Institute, which is listed as one of the study’s trial sites on clinicaltrials.gov. The trial was halted at one site in early April, another about two weeks ago and others “several” and “a couple” weeks ago. One trial site said they received a calendar invite from the company for tomorrow. “Shanghai is not in a happy place,” one of the trial sites said, citing the Covid-19 lockdowns currently taking place in the city. Endpoints has reached out to multiple phone numbers and emails associated with Green Valley and will update accordingly. At the time of its IND clearance in April 2020, Green Valley said it would work with IQVIA on the trial. A spokesperson for the CRO told Endpoints in an emailed statement: “It’s our corporate policy to defer all study questions to the respective study sponsors.” The news comes after CMO Samuel Agus left his post last month, according to his LinkedIn profile. The study kicked off in October 2020 and had expected to enroll 2,046 patients with mild to moderate Alzheimer’s. At the time of the IND clearance news, Green Valley said it planned to wrap up the trial in 2024 and submit an NDA by 2025. In January, the biotech said the trial was now slated for completion by 2025 and that it had screened 949 patients and had 292 randomized, thus far. At that time, 154 clinical centers in 10 countries and regions had been activated. Green Valley has described the drug as: “Being the world’s first AD drug that targets the gut-brain axis, GV-971 reduces peripheral and central inflammation by reconditioning the gut microbiota and inhibiting the abnormal balance of gut microbiota-derived metabolites.” China’s regulators conditionally approved the drug in November 2019, sending shockwaves into the Alzheimer’s drug development world as there hadn’t been a new medicine for the memory-robbing disease in nearly two decades. But experts were “cautiously optimistic” following the nod. Related:Alzheimer's breakthrough? Not so fast — experts poke holes in data underlying China's surprise approval “The other scientific advisors and I were excited about the chance to help the company design a rigorous global Phase 3 clinical trial. We were interested in the drug’s potentially novel mechanism of action, the initial basic science and clinical trial findings from China, the chance to clarify the drug’s efficacy, and potential implications for the role of the microbiome in the development and treatment of Alzheimer’s disease,” Reiman told Endpoints. The drug was included in China’s national reimbursement drug list late last year, Green Valley said in December 2021, reducing the monthly medication cost from RMB 3,580 ($531) to RMB 1,184 ($175). The FDA also cleared an IND for a Phase II study of the drug in patients with early-stage Parkinson’s, Green Valley said in January. That trial is expected to include 300 patients at 30 centers in North America and Asia-Pacific over the course of a 36-week study. The news comes as Biogen and Eisai said Monday that they completed the submission for their second Alzheimer’s treatment, dubbed lecanemab, and as Eli Lilly works on its application for its drug donanemab. Green Valley was founded in 1997 and employs 1,500 people, according to the company’s website.

Small molecular drug

100 Deals associated with Sodium Oligomannurarate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	N07	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alzheimer Disease	CN	Green Valley (Shanghai) Pharmaceutical Technology Co., Ltd.	02 Nov 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	CN	Shanghai Green Valley Pharmaceutical Co., Ltd.	01 Apr 2014
Alzheimer Disease	Phase 2	CN	Ocean University of China	01 Apr 2014
Pancreatitis	Preclinical	CN	Guangzhou Medical University	27 Sep 2024
Parkinson Disease	Preclinical	US	Shanghai Green Valley Pharmaceutical Co., Ltd.	16 Dec 2021
Alzheimer Disease	Discovery	CN	Ocean University of China	01 Apr 2014
Alzheimer Disease	Discovery	CN	Shanghai Green Valley Pharmaceutical Co., Ltd.	01 Apr 2014
Cognitive Dysfunction	Discovery	CN	Shanghai Green Valley Pharmaceutical Co., Ltd.	01 Apr 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02293915 (Pubmed \| Alzheimers Res Ther) Manual	Phase 3	Alzheimer Disease	818	GV-971	(vajhabtsia): difference = -2.15 (95% CI, - 3.07 - - 1.23), P-Value = <0.0001	Positive	17 Mar 2021
				Placebo
NCT01453569 (CTgov)	Phase 2	Alzheimer Disease \| Cognitive Dysfunction	255	Sodium oligo-mannurarate 900mg (Sodium Oligo-mannurarate 900mg)	bnquvnksdc(tbmavjywza) = fmgznnkvyx jmacbtgojc (qfhekhixhh, vqvupedtye - olhfhgjefc) View more	-	27 Jan 2015
				Sodium oligo-mannurarate 600mg (Sodium Oligo-mannurarate 600mg)	bnquvnksdc(tbmavjywza) = rjworpnawx jmacbtgojc (qfhekhixhh, cfocurbrdq - uikteupzgm) View more

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