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announcement on early termination of gv-971 global multi-center phase iii clinical trial
date:2022-05-13

sodium oligomannate (coded "gv-971") is a china-developed novel drug and was approved for treating alzheimer's disease (ad) by china's national medical products administration on 2 november 2019 following fast-track review [1], and received approval from the us food and drug administration for the investigational new drug (ind) application for global multi-center phase iii clinical trial ("gv-971 global phase iii trial") on 8 april 2020 [2] [3].

 

gv-971 global phase iii trial was lunched at the beginning of the global covid-19 pandemic, a time when the pandemic was forcing pharmaceutical companies worldwide to suspend or freeze their clinical trials, and causing varying degrees of loss [4] [5].

 

thanks to the joint efforts of the sponsor, investigators, cros, suppliers as well as the kind support from the subjects and their families over the past two years, gv-971 global phase iii trial has overcome a great many difficulties and negative impacts that the global pandemic has brought in various aspects, such as site initiation, patient screening, enrollment, and follow-up, and have successfully achieved key study milestones.

 

approved by regulatory authorities in 11 countries/regions, gv-971 global phase iii trial has been carried out in 162 clinical centers around the world. as of 26 april 2022, 1,308 patients had been screened, and 439 subjects had been randomized, including 257 in north america, 118 in europe, and 64 in china [6].

 

on 21 january 2022, the third-party data and safety monitoring board (dsmb) analyzed the safety data of gv-971 global phase iii trial when the enrollment reached the 10% milestone and recommended the study to continue without further modifications, based on the conclusion that "there are no safety risks associated with the continuation of the study" [6].

 

to ensure funding for the huge undertake of gv-971 global phase iii trial, green valley, as the sponsor, has endured the pandemic's negative impacts on its business operations, and launched a financing plan in the capital market. but regrettably, the plan coincided with the harshest winter in the capital market and the geopolitical instability at the beginning of 2022, resulting in insufficient financing [7] [8]

 

the covid-19 resurgences across china since the beginning of 2022 have also had an impact on the existing marketing channels of in-hospital prescription products including gv-971, leading to a material adverse effect on sales. at the same time, after more than two years of activating international clinical centers, gv-971 global phase iii trial has witnessed accelerated enrollment rate and entered an unprecedented peak period, generating a huge need for funds. and due to the characteristics and needs of cognitive function assessment for ad patients, the repeated and regionally differential outbreaks of the pandemic have made subjects unable to visit clinical centers on schedule, resulting in an increasing trend of dropout rate as well as rising quality risks and research costs for the clinical trial [9] [10].

 

given such unfavorable factors outside the company's control, to be accountable to subject safety, trial quality and integrity, investigators and clinical centers, and after careful evaluation referring to the clinical trial management guidelines during covid-19 issued by international regulatory and research organizations, green valley, as the sponsor, under the current circumstances, was forced to make a prudent decision: terminate gv-971 global phase iii trial (fda ind: 144482; nmpa approval no.: cxhb2000033) earlier than planned.

 

green valley strictly abides by the requirements of ich-gcp regulations, and has initiated and is implementing the following actions in an orderly manner:

1. engage all parties involved in the clinical trials, regulatory autorities, clinical investigators, clinical trial institutions, and clinical trial service providers by formal written communication and coordination, to minimize any possible impact of the early termination;

2. stop all screening and enrollment, inform and recall enrolled subjects for early termination visits for the safe drug withdrawal of all subjects, and re-enable standard treatment according to regulations to ensure that all subjects complete the corresponding safety visits, their safety is guaranteed to the greatest extent, and their rights and interests are protected;

3. carry out center closure in an orderly manner and in accordance with applicable laws and regulations.

 

just like all global investigators and partners who have devoted a lot, green valley has also invested huge financial and material resources in gv-971 global phase iii trial. the early termination of the trial is undoubtedly a huge loss for green valley and all investigators, which we greatly regret.

 

the development of gv-971 would have never been possible without the support of researchers, clinicians, patients and their families, regulatory authorities, and all sectors of the society. green valley will make every effort to ensure a smooth progress of gv-971 ongoing post-launch clinical trials, including two 2-year post-launch studies – one for long-term efficacy and safety (ctr20210187; sample size: 800), and one for long-term safety (ctr20210760; sample size: 2,500) – both are now in the stage of patient enrollment and are advancing normally [11] [12]. the long-term efficacy and safety studies will also include blood biomarkers related to the mechanism of action of gv-971 and the examination of the gut microbiota, to further evaluate the drug's long-term effects on ad patients as well as on biomarkers based on the results of gv-971 china phase iii clinical trial and pre-clinical study on the mechanism of action [13] [14].

 

china is now home to the world's largest population of about 10 million ad patients [15]. as the pandemic situation gradually eases, green valley will accelerate the access of gv-971 to market and hospital as it has been included in china national reimbursement drug list, and spearhead all available resources to improve the existing market. as the outstanding therapeutic effects of gv-971 have been observed on more and more patients following its market launch in china, an increasing number of doctors have started to recognize its unique clinical value [16]. gv-971 has also been included in major authoritative diagnosis and treatment guidelines and expert consensuses for clinical medicine as well as the national reimbursement drug list [17] [18], which is expected to benefit more chinese patients in the future. at the same time, celebrating a mission of "developing only the medicine that human beings most hope for", green valley will stay committed to the goal of the global registration and marketing of gv-971 and will relaunch gv-971 global clinical trial when conditions permit, and make this innovative ad drug available to patients worldwide as early as possible.

 

the research on complex brain diseases such as ad presents a lengthy journey of exploration, and scientists and pharmaceutical companies around the world have made arduous efforts for this. as the developer of gv-971, we are willing to engage in sincere exchanges and scientific collaboration with scientists and researchers both in china and around the world, to conduct more in-depth research on its unique mechanism of action and long-term therapeutic value, and to contribute to the realization of our shared dream of conquering alzheimer's disease.

 

green valley (shanghai) pharmaceuticals co., ltd.

may 13, 2022

 

 

 

1.china national medical products administration. work procedures of drug review and approval for conditional market launch. retrieved from:

https://www.cnppa.org/public/editor/attached/file/20200506/20200506143415_28611.pdf 

2.china national health commission. gv-971, fruit of national major sci-tech program for novel drug development, gets approved for market launch. retrieved from:

http://www.nhc.gov.cn/wjw/xwdt/201911/3d563fc6866942b8a561081fbdeb3062.shtml 

3.green valley pharmaceuticals. usfda approves sodium oligomannate (gv-971) for proposed international phase-ii clinical trial in treating parkinson’s disease. retrieved from:

https://www.greenvalleypharma.com/cn/index/pageview/catid/15/id/46.html 

4.van dorn a. covid-19 and readjusting clinical trials[j]. the lancet, 2020, 396(10250): 523-524. 

5.ben fidler. lilly, galapagos halt trials as coronavirus deepens impact on drug research. retrieved from: https://www.biopharmadive.com/news/coronavirus-eli-lilly-galapagos-clinical-trials-biotech-pharma/574667/ 

6.data on file:gv971-007 dsmb data review meeting no.1 

7.arab news .global ipo activity drops 70% in q1 of 2022:bloomberg .retrieved from: https://www.arabnews.com/node/2051326/business-economy 

8.world health organization. who coronavirus (covid-19) dashboard. retrieved from:https://covid19.who.int/ 

9.li h, wang m, lun b, wu y. the impact of the covid-19 pandemic on clinical trials under study and suggestions for countermeasures [j]. chinese journal of evidence-based medicine, 2020,20(08):871-877. 

10.us food and drug administration. conduct of clinical trials of medical products during the covid-19 public health emergency[j]. guidance for industry, investigators, and institutional review boards, 2021. 

11.xin x. a clinical study to evaluate the long-term safety of sodium oligomannate capsules (gv-971) (ctr20210760). retrieved from:

https://www.wuxuwang.com/linchuang/f8ba8a87-9cdf-11eb-8ee7-b8599fb47a0c 

12.xin x. a clinical study to evaluate the long-term efficacy and safety of sodium oligomannate capsules (gv-971) (ctr20212999). retrieved from:

https://www.wuxuwang.com/linchuang/e39a84e7-5bb9-11ec-aae7-0a6bfd409a9a 

13.xiao s, chan p, wang t, et al. a 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate alzheimer’s dementia[j]. alzheimer's research & therapy, 2021, 13(1): 1-11. 

14.bio art. cell research special report | geng meiyu's team reveals the mechanism of action of gv-971, china's original novel drug for treating alzheimer's disease. retrieved from:

http://www.bioart.com.cn/index.php?m=content&c=index&a=show&catid=11&id=542 

15.jia l, quan m, fu y, et al. dementia in china: epidemiology, clinical management, and research advances[j]. the lancet neurology, 2020, 19(1): 81-92. 

16.parts of case study research papers published after gv-971’s market launch 

1)zhao w. a case of alzheimer's disease with irritable bowel syndrome treated with sodium oligomannate [j]. chinese journal of new drugs and clinical remedies, 2021,40(10):734-736.doi:10.14109/j.cnki.xyylc.2021.10.13. 

2)gao j, wang w. a case of sodium oligomannate improving cognitive function, behavioral & mental symptoms, and daily life functions in patient with alzheimer's disease after ovarian cancer surgery [j]. chinese journal of new drugs and clinical remedies, 2021,40(11):797-800.doi:10.14109/j.cnki.xyylc.2021.11.16. 

3)sun w. a case of alzheimer's disease with epilepsy treated with sodium oligomannate in combination with levetiracetam [j]. chinese journal of new drugs and clinical remedies, 2021,40(12):861-864. 

4)he y, luo x. a case of vascular dementia treated with sodium oligomannate [j]. chinese journal of new drugs and clinical remedies, 2022,41(1):60-62. 

5)hu x, zhan z, lv d, pan y. a case of behavioral variant frontotemporal dementia treated with sodium oligomannate in combination with memantine [j]. chinese journal of new drugs and clinical remedies, 2022,41(2):125-128. 

6)qi c, feng h, lou z. a case of apoe ε3/ε4 alzheimer's disease treated with sodium oligomannate in combination with donepezil [j]. chinese journal of new drugs and clinical remedies, 2022,03:189-192. 

17.clinical guidelines and consensuses that have included gv-971 after its market launch 

1)china national health commission. guidelines for the diagnosis and treatment of alzheimer’s disease (2020 edition). retrieved from:

http://www.abiggp.com/management/common/kindeditor/attached/file/20210315/20210315140159_5317.pdf 

2)china national health commission. guidelines for the diagnosis and treatment of mental disorders (2020 edition). retrieved from:

http://www.nhc.gov.cn/yzygj/s7653p/202012/a1c4397dbf504e1393b3d2f6c263d782/files/763f4289c2304524a429b79370cb56f3.pdf 

3) chinese society of neurology under the chinese medical association. chinese guidelines for the prevention and treatment of elderly dementia [m]. beijing: people’s medical publishing house. 2021. 

4) vascular cognitive impairment branch of chinese stroke association, wang k, dong q, et al. expert consensus on the management of post-stroke cognitive impairment 2021 [j]. chinese journal of stroke, 2021, 16(4):14. 

5)shi h, xu j. expert consensus on the nutritional intervention for brain health in alzheimer's disease [j]. scientia sinica vitae, 2021. 

6)dementia and cognitive impairment group of neurology branch of chinese medical association. chinese expert consensus on the diagnosis and treatment of mild cognitive impairment due to alzheimer's disease 2021 [j]. chinese journal of neurology, 2022,55(5):421-440. 

18.china national medical products administration. press interview of national medical products administration on updating the national reimbursement drug list in 2021. retrieved from:

https://mp.weixin.qq.com/s/kuzx2ruivdc7obfrddzhga

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