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一项里程碑式的I期随机双盲临床试验显示,高剂量Niagen®、专利烟酰胺核糖(NR)补充剂可诱导强效NAD+反应,并与帕金森病(PD)的轻度改善有关

A Milestone Phase I Randomized, Double-Blind Clinical Trial Demonstrates High-Dose Niagen ® , Patented Nicotinamide Riboside (NR), Supplementation Induces a Potent NAD + Response and Is Associated With Mild Improvement in Parkinson's Disease (PD)

businesswire 等信源发布 2023-11-30 20:34

可切换为仅中文


LOS ANGELES--(BUSINESS WIRE)--ChromaDex Corp. (NASDAQ:CDXC), a global authority on Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging research, shares results from a new breakthrough study analyzing the safety of high-dose nicotinamide riboside (NR) supplementation on individuals with Parkinson’s disease (PD).

洛杉矶-(商业时报)-全球烟酰胺腺嘌呤二核苷酸(NAD+)和健康老龄化研究权威机构ChromaDex Corp.(纳斯达克股票代码:CDXC)分享了一项新的突破性研究的结果,该研究分析了高剂量烟酰胺核糖苷(NR)补充帕金森病(PD)患者。

This study was part of the ChromaDex External Research Program (CERP™), which donated ChromaDex’s patented NR ingredient, Niagen®, the most efficient and high quality NAD+ precursor, for the advancement of this research..

本研究是ChromaDex外部研究项目(CERP)的一部分™),捐赠了ChromaDex专利的NR成分Niagen®,这是最有效和最优质的NAD+前体,用于推进这项研究。。

In a pioneering development for PD treatment, this landmark phase I randomized, double-blind clinical study reported in the peer-reviewed journal Nature Communications by a team of scientists led by Prof. Charalampos Tzoulis, Haukeland University Hospital and University of Bergen in Norway, demonstrated that supplementing individuals with PD with high-dose (3,000 mg daily) Niagen NR was short-term safe, greatly increased whole blood NAD+ levels, augmented the NAD+ metabolome, and was associated with a significant clinical improvement.

在PD治疗的开创性发展中,这项具有里程碑意义的I期随机双盲临床研究由挪威Haukeland大学医院和卑尔根大学Charalampos Tzoulis教授领导的科学家团队在同行评审的Nature Communications杂志上报道,证明用高剂量(每日3000mg)烟碱NR补充PD患者是短期安全的,大大增加了全血NAD+水平,增加了NAD+代谢组,并且与显着的临床改善相关。

These results build upon previous research led by Dr. Tzoulis (Cell Metabolism) and showcase that supplementation with Niagen NR may be a therapeutic strategy for PD, pending further research..

这些结果建立在Tzoulis博士(细胞代谢)领导的先前研究的基础上,并展示补充Niagen NR可能是PD的治疗策略,有待进一步研究。。

With several studies demonstrating the safety and tolerability of 2,000mg of Niagen NR, this marks a milestone as the first-ever clinical study to demonstrate the safety, tolerability, and beneficial effects of high-dose Niagen NR at 3,000 mg per day.

有几项研究证明了2000mg Niagen NR的安全性和耐受性,这是首次证明高剂量Niagen NR每天3000 mg的安全性,耐受性和有益作用的临床研究的里程碑。

“As the world's leading company in NAD+ research and commercialization, ChromaDex is proud to announce this groundbreaking NR-SAFE study from Dr. Tzoulis and his team of researchers that reveals the potential of Niagen NR as a therapy for Parkinson's disease. PD affects more than 10 million people worldwide,” noted Rob Fried, CEO of ChromaDex.

“作为NAD+研究和商业化的世界领先公司,ChromaDex很自豪地宣布Tzoulis博士及其研究团队开展的这项开创性的NR-SAFE研究,揭示了Niagen NR作为帕金森病治疗的潜力.PD影响全球超过1000万人,“ChromaDex首席执行官Rob Fried指出。

“This research not only demonstrates the safety and tolerability of high-dose Niagen NR but also highlights its ability to significantly increase NAD+ levels and potentially improve the clinical severity of PD.'.

“这项研究不仅证明了高剂量烟碱NR的安全性和耐受性,而且突出了其显着增加NAD+水平并可能改善PD临床严重程度的能力。”。

PD is a common neurodegenerative disorder largely characterized by progressive impairments in motor function, including tremors, stiffness, slow movement, and poor balance, as well as in non-motor functions, such as abnormal sleep patterns, gastrointestinal dysfunction, and cognitive impairment, or dementia.

PD是一种常见的神经退行性疾病,其主要特征在于运动功能的进行性损伤,包括震颤,僵硬,运动缓慢和平衡不良,以及非运动功能,例如异常睡眠模式,胃肠功能障碍和认知障碍,或痴呆症。

Current treatment options are limited, and there is a pressing need for innovative approaches to manage the effects of this debilitating neurodegenerative disorder..

目前的治疗选择是有限的,迫切需要创新的方法来管理这种使人衰弱的神经退行性疾病的影响。。

“Results of this study build on previous research conducted by our lab, demonstrating that oral NR therapy increases NAD+ levels in the brain of individuals with PD and this is associated with ameliorated brain metabolism and mild clinical improvement,” commented Prof. Charalampos Tzoulis, Professor of Neurology and Neurogenetics, Director of the K.G Jebsen Center for Translational Research in Parkinson’s disease, and Co-Director of the Neuro-SysMed Research Center, University of Bergen and Haukeland University Hospital, Bergen, Norway.

神经病学和神经遗传学教授Charalampos Tzoulis教授评论说:“这项研究的结果建立在我们实验室以前的研究基础上,证明口服NR治疗可增加PD患者大脑中的NAD+水平,这与改善大脑代谢和轻度临床改善有关,K.G Jebsen帕金森病转化研究中心主任,卑尔根大学神经SysMed研究中心和挪威卑尔根Haukeland大学医院联合主任。

“Abnormal energy metabolism due to dysfunction in the mitochondria has been linked to PD and is believed to play a role in the initiation and progression of the disease. Our previous findings have nominated NR as a potential disease-modifying therapy for PD, which will not only target and rectify disease-specific processes, but may also optimize neuronal metabolism and fortify neurons, rendering them more resilient against age-related stress and neurodegeneration.

“由于线粒体功能障碍导致的能量代谢异常与PD有关,并被认为在疾病的发生和发展中发挥作用。我们之前的研究结果提名NR作为PD的潜在疾病改善疗法,不仅可以针对和纠正疾病特定的过程,还可以优化神经元代谢并强化神经元,rendering它们更能抵抗与年龄有关的压力和神经变性。

However, to harness the full therapeutic potential of NR, we need to explore higher dose regimens. This study establishes the short-term safety of 3,000 mg NR daily and allows the clinical community to explore high-dose options in future therapeutic trials. As for conclusive proof on the therapeutic potential of NR in PD, we look forward to the results from our year-long NO-PARK phase II/III study on 400 persons with PD, which is already ongoing at our Center, and estimated to conclude by the end of 2024.” Public information on the NO-PARK study can be viewed at neuro-sysmed.no and at www.clinicaltrials.gov.

然而,为了充分利用NR的治疗潜力,我们需要探索更高剂量的方案。该研究确定了每日3000 mg NR的短期安全性,并允许临床团体在未来的治疗试验中探索高剂量选择。至于NR在PD中的治疗潜力的确凿证据,我们期待我们对400名PD患者进行为期一年的NO-PARK II/III期研究的结果,该研究已经在我们中心进行,并估计到2024年底结束。“关于NO-PARK研究的公开信息可以在neuro-sysmed.NO和www.clinicaltrials.gov上查看。

Notably, all of Prof. Tzoulis’ clinical research is academically-driven and based largely on public funding..

值得注意的是,Tzoulis教授的所有临床研究都是学术驱动的,主要基于公共资金。。

About the study

关于这项研究

Dr. Tzoulis and his team of researchers sought to assess short-term tolerability and impact on NAD+ as well as clinical severity of PD. Exploratory outcomes included changes in serum homocysteine levels, fasting blood glucose, and serum insulin levels.

Tzoulis博士及其研究小组试图评估短期耐受性和对NAD+的影响以及PD的临床严重程度。探索性结果包括血清同型半胱氨酸水平,空腹血糖和血清胰岛素水平的变化。

The study was a randomized, double-blind, placebo-controlled, phase I clinical trial in 20 individuals with idiopathic PD fulfilling the criteria set by the Movement Disorders Society (MDS). Individuals with PD were given 3,000 mg of NR per day or placebo for four consecutive weeks. They were assessed based on clinical and molecular measures, an electrocardiogram, and through the MDS-UPDRS rating scale, a tool used by medical professionals and researchers to assess and measure the severity of PD symptoms..

该研究是一项随机,双盲,安慰剂对照的I期临床试验,对20名符合运动障碍协会(MDS)设定标准的特发性PD患者进行了研究。PD患者连续四周每天给予3000 mg NR或安慰剂。根据临床和分子测量,心电图以及MDS-UPDRS评定量表(医学专业人员和研究人员用于评估和测量PD症状严重程度的工具)对它们进行评估。。

Study highlights

研究亮点

High-dose NR was safe and well-tolerated with no related adverse events.

高剂量NR安全且耐受性良好,无相关不良事件。

NR significantly increased NAD+ levels and modified the NAD+ metabolome in whole blood.

NR显着增加NAD+水平并改变全血中的NAD+代谢组。

High-dose NR did not alter whole blood homocysteine, or other major methyl donor groups, suggesting no impact on methyl donor group pool.

高剂量NR不改变全血同型半胱氨酸或其他主要甲基供体基团,表明对甲基供体基团库没有影响。

NR was associated with a significant improvement of clinical symptoms of PD, measured by MDS-UPDRS, suggesting augmenting NAD+ levels may have a symptomatic anti-Parkinson's effect.

通过MDS-UPDRS测量,NR与PD的临床症状的显着改善相关,表明增加NAD+水平可能具有症状性抗帕金森病作用。

Relevance

关联

This promising milestone research demonstrates that high-dose NR at 3,000 mg per day is safe, well-tolerated, and may improve clinical symptoms for PD. These results set the stage for the long-term NO-PARK Phase II/III clinical study, which will determine if NR can delay disease progression in persons with PD.

这项有希望的里程碑研究表明,每天3000毫克的高剂量NR是安全的,耐受性良好的,可能会改善PD的临床症状。这些结果为长期的公园II/III期临床研究奠定了基础,这将决定NR是否可以延缓PD患者的疾病进展。

Further, Prof. Tzoulis and his team of investigators are conducting the N-DOSE clinical trial to determine the optimal safe dose to assess the efficacy of NR as part of the treatment of PD (clinicaltrials.gov)..

此外,Tzoulis教授和他的研究小组正在进行N剂量临床试验,以确定最佳安全剂量,以评估NR作为PD治疗一部分的疗效(clinicaltrials.gov)。。

For additional information on the science supporting Niagen® visit www.chromadex.com.

有关支持Niagen®的科学的更多信息,请访问www.chromadex.com。

About ChromaDex:

关于ChromaDex:

ChromaDex Corp. is a global bioscience company dedicated to healthy aging. The ChromaDex team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), levels of which decline with age. ChromaDex is the innovator behind NAD+ precursor nicotinamide riboside (NR), commercialized as the flagship ingredient Niagen®.

ChromaDex Corp.是一家致力于健康老龄化的全球生物科学公司。包括世界知名科学家在内的ChromaDex团队正在对烟酰胺腺嘌呤二核苷酸(NAD+)进行开创性研究,其水平随着年龄的增长而下降。ChromaDex是NAD+前体烟酰胺核苷(NR)的创新者,作为旗舰成分Niagen®商业化。

Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio. ChromaDex maintains a website at www.chromadex.com to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company..

烟酰胺核苷和其他NAD+前体受ChromaDex专利组合的保护。ChromaDex在www.ChromaDex.com维护一个网站,ChromaDex定期向该网站发布其新闻稿的副本以及有关该公司的其他财务信息。。

Forward-Looking Statements:

前瞻性声明:

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to whether the study revealed groundbreaking insights into the potential of Niagen NR ingredient as a therapy for Parkinson's disease and whether this research not only demonstrates the safety and tolerability of high-dose Niagen NR but also highlights its ability to significantly increase NAD+ levels and improve the clinical severity of PD.

本版本包含1933年“证券法”第27A条(经修订)和1934年“证券交易法”第21E条(经修订)含义内的前瞻性声明,包括有关该研究是否揭示了Niagen NR成分作为帕金森病治疗潜力的开创性见解,以及该研究是否不仅证明了高剂量Niagen NR的安全性和耐受性,而且还强调了其显着增加NAD+水平的能力并改善PD的临床严重程度。

Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plans,' 'potential,' 'possible,' 'probable,' 'believes,' 'seeks,' 'may,' 'will,' 'should,' 'could' or the negative of such terms or other similar expressions.

不是对历史事实的描述的陈述构成前瞻性陈述,并且通常(但不总是)可以通过使用诸如“期望”,“预期”,“意图”,“估计”,“计划,“潜力”,“可能”,“可能”,“相信”,“寻求”,“可能”,“将会”,“应该”或这些术语或其他类似表达的否定。

Risks that contribute to the uncertain nature of these forward-looking statements include the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition.

导致这些前瞻性声明性质不确定的风险包括COVID-19大流行对我们业务和全球经济的影响;我们的经营损失历史和需要获得额外融资;我们产品销售的增长和盈利能力;我们保持销售,营销和分销能力的能力;改变消费者对我们产品的看法;我们依赖单一或有限数量的第三方供应商;以及与我们的业务和财务状况相关的风险和不确定性。

More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, ChromaDex's Quarterly Reports on Form 10-Q and other filings .

有关ChromaDex的更详细信息以及可能影响实现前瞻性报表的风险因素,请参阅ChromaDex在截至2022年12月31日的财政年度10-K表格的年度报告,ChromaDex关于表格10-Q的季度报告和其他文件。