Awakn Announces Opening of Four Additional AWKN-001 Phase 3 Trial Sites
Awakn Announces Opening of Four Additional AWKN-001 Phase 3 Trial Sites
Toronto, Ontario--(Newsfile Corp. - October 22, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, announces the opening of four additional clinical trial sites: University Hospitals Sussex NHS Foundation Trust; South London and Maudsley NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; and University Hospitals Plymouth NHS Trust. This brings the total active trial sites to 7 in the landmark 'MORE-KARE' Phase 3 trial of AWKN-001 for severe AUD.
安大略省多伦多--(Newsfile Corp.,2024年10月22日)——开发药物滥用和心理健康障碍疗法的临床阶段生物技术公司Awakn Life Sciences Corp.(CSE:AWKN)(OTCQB:AWKNF)(FSE:954)(“Awakn” 或 “公司”)宣布再开放四个临床试验地点:苏塞克斯大学医院 NHS 基金会信托基金;南伦敦和莫兹利 NHS基金会信托基金;大曼彻斯特心理健康NHS基金会信托基金;普利茅斯大学医院NHS信托基金。这使具有里程碑意义的 “MORE-KARE” 针对重症澳元的 AWKN-001 三期试验的活跃试验点总数达到7个。
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe AUD.
AWKN-001 是一种正在研究的新型药物辅助治疗重度澳元,由静脉注射(IV)的 N-甲基-D-天冬氨酸受体调节药物(氯胺酮)与重度澳元的手动心理社会支持相结合。
The MORE-KARE study, or the Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse, is co-funded by a partnership between the UK's Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. It is managed by the Exeter Clinical Trials Unit at the University of Exeter.
MORE-KARE研究,即氯胺酮减少酒精复发的多中心研究,由英国医学研究委员会(MRC)和国家健康与保健研究所(NIHR)和Awakn Life Sciences Corp. 共同资助。该研究由埃克塞特大学埃克塞特临床试验部门管理。
The Phase 3 trial aims to evaluate the efficacy of a single treatment cycle of AWKN-001. Participants will be randomly allocated into a trial arm, receiving different doses of ketamine infusion along with psycho-social support sessions from a trial therapist. The specific dose and type of psychological support for each participant will be randomly assigned by a computer. Both participants and the research team will be blinded to the assigned dose/support.
这项 3 期试验旨在评估 AWKN-001 单一治疗周期的疗效。参与者将被随机分配到试验组,接受不同剂量的氯胺酮输液,并接受试验治疗师的心理社会支持。每位参与者的具体剂量和心理支持类型将由计算机随机分配。参与者和研究小组都将对指定的剂量/支持视而不见。
Anthony Tennyson, CEO, Awakn, commented: "The expansion of trial sites marks a significant milestone in our mission to address the pressing need for innovative treatments for AUD. We are confident that AWKN-001, has the potential to change the standard of care for individuals suffering from severe alcohol use disorder in the UK, offering them a novel, more effective treatment pathway."
Awakn首席执行官安东尼·坦尼森评论说:“试验场所的扩建标志着我们满足澳元对创新疗法的迫切需求这一使命中的一个重要里程碑。我们相信,AWKN-001 有可能改变英国严重酒精使用障碍患者的护理标准,为他们提供一种新颖的、更有效的治疗途径。”
Prof. David Nutt, Chief Research Officer of Awakn, added: "The opening of these additional sites accelerates our ability to gather robust clinical data, essential for bringing this groundbreaking treatment to more patients. With the support of the UK's leading research institutions, we are well-positioned to demonstrate the effectiveness of AWKN-001."
Awakn首席研究官戴维·纳特教授补充说:“这些额外研究中心的开放加快了我们收集可靠临床数据的能力,这对于将这种开创性的治疗方法带给更多患者至关重要。在英国领先研究机构的支持下,我们完全有能力证明 AWKN-001 的有效性。”
This study is the largest of its kind investigating ketamine-assisted therapy for AUD. The total trial cost is estimated at £2.4 million / CAD 4.2 million, with Awakn contributing £0.8 million / CAD 1.4 million. The trial is being conducted at eight National Health Service (NHS) sites across the UK.
这项研究是研究氯胺酮辅助治疗澳元的同类研究中规模最大的研究。总试用费用估计为240万英镑/420万加元,其中Awakn出资80万英镑/140万加元。该试验正在英国的八个国家卫生服务(NHS)站点进行。
About AWKN-001
关于 AWKN-001
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support in the UK market only.
AWKN-001 是一种正在研究的新型药物辅助治疗重度澳元,由静脉注射(IV)的 N-甲基-D-天冬氨酸受体调节药物(氯胺酮)与手动心理社会支持相结合,仅在英国市场上提供。
A phase 2 trial was successfully completed with efficacy proven, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial and a 50% reduction in Heavy Drinking Days versus placebo.
一项2期试验成功完成,疗效得到证实,与安慰剂相比,治疗后的6个月平均禁欲率为86%,而试验前为2%,重度饮酒天数减少了50%。
A phase 3 clinical trial ("MORE KARE") is being run by the University of Exeter. This trial is co-funded by the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the UK's National Institute for Health Research (NIHR) and the Medical Research Council (MRC) - and Awakn Life Sciences Corp.
埃克塞特大学正在进行一项3期临床试验(“MORE KARE”)。该试验由疗效与机制评估(EME)计划共同资助,该计划由英国国家卫生研究院(NIHR)和医学研究委员会(MRC)与Awakn Life Sciences Corp. 共同资助
About Awakn Life Sciences Corp.
Awakn 生命科学公司简介
Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on AUD, a condition affecting approximately 29 million adults in the US and approximately 40 million in the US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.
Awakn Life Sciences Corp. 是一家处于临床阶段的生物技术公司,开发针对药物使用和心理健康障碍的疗法。Awakn的近期重点是澳元,这种疾病影响了美国约2900万名成年人,而目前的护理标准不足的美国和主要欧洲市场则影响了约4000万澳元。我们的目标是为急需的成瘾患者提供突破性疗法,我们的战略侧重于通过多个渠道将我们的研发渠道商业化。
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About the University of Exeter
埃克塞特大学简介
The University of Exeter is the sponsor of this clinical trial with overall trial management, data management and statistical analysis provided in collaboration with the Exeter Clinical Trials Unit (University of Exeter). At the University of Exeter, we combine teaching excellence and high levels of student satisfaction with world class research at our campuses in Exeter and Cornwall. We are a member of the Russell Group of leading research-intensive universities.
埃克塞特大学是这项临床试验的赞助商,与埃克塞特临床试验部门(埃克塞特大学)合作提供整体试验管理、数据管理和统计分析。在埃克塞特大学,我们将卓越的教学和较高的学生满意度与埃克塞特和康沃尔校区的世界一流研究相结合。我们是领先的研究密集型大学罗素集团的成员。
About The National Institute for Health and Care Research (NIHR)
关于国家健康与保健研究所(NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
国家健康与保健研究所(NIHR)的使命是通过研究改善国家的健康和财富。我们通过以下方式做到这一点:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
- 资助有利于国民保健服务、公共卫生和社会护理的高质量、及时的研究;
- 投资世界一流的专业知识、设施和熟练的送货员工,将发现转化为更好的治疗和服务;
- 与患者、服务用户、护理人员和社区合作,提高我们研究的相关性、质量和影响力;
- 吸引、培训和支持最优秀的研究人员,以应对复杂的健康和社会护理挑战;
- 与其他公共资助者、慈善机构和行业合作,帮助建立一个具有凝聚力和全球竞争力的研究体系;
- 资助应用全球健康研究和培训,以满足低收入和中等收入国家最贫穷人口的需求。
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
NIHR 由卫生和社会保健部资助。它在低收入和中等收入国家的工作主要由英国政府的英国援助提供资金。
About the Medical Research Council
关于医学研究委员会
The UKRI Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed.
UKRI医学研究委员会站在改善人类健康的科学发现的最前沿。MRC成立于1913年,旨在应对结核病,现在将纳税人的钱投资于世界上各个健康领域的最佳医学研究。33名由MRC资助的研究人员在各个学科中获得了诺贝尔奖,MRC的科学家们支持了维生素、DNA结构以及吸烟与癌症之间的联系等多种发现,以及开创性地使用随机对照试验、发明核磁共振成像扫描以及开发一组用于制造有史以来最成功药物的抗体等成就。
Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation.
如今,MRC资助的科学家正在解决21世纪人类面临的一些最大的健康问题,从与衰老相关的慢性病的上升到快速变异的微生物构成的威胁。医学研究委员会是英国研究与创新的一部分。
Notice Regarding Forward-Looking Information
关于前瞻性信息的通知
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
本新闻稿包含适用的证券法(以下统称为 “前瞻性陈述”)中定义的某些前瞻性信息和前瞻性陈述。前瞻性陈述反映了当前对未来事件或公司未来业绩的预期或信念。除历史事实陈述以外的所有陈述均为前瞻性陈述。通常,但并非总是如此,前瞻性陈述可以通过使用 “计划”、“期望”、“预期”、“预算”、“预期”、“估计”、“继续”、“预测”、“项目”、“预测”、“打算”、“预期”、“目标” 或 “相信” 等词语来识别,或者这些词语和短语或陈述的否定词,“可能”、“可能”、“将”、“应该”、“可能” 或 “将” 被采取、发生或实现的事件或结果,包括与公司业务有关的声明。所有前瞻性陈述,包括本文中的前瞻性陈述,均受本警示性陈述的限制。
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
尽管公司认为此类陈述中表达的预期基于合理的假设,但此类陈述并不能保证未来的业绩,实际业绩或发展可能与声明中的业绩或发展存在重大差异。某些因素可能导致实际业绩与前瞻性信息中的结果存在重大差异。其中包括但不限于:总体宏观经济状况的波动;公司的业务计划和战略;公司在高度监管的企业中遵守所有适用的政府法规的能力;投资运营历史有限或没有运营历史且从事某些司法管辖区目前被视为非法活动的目标公司或项目的固有风险;法律变化;运营历史有限;对管理的依赖;对额外融资的要求;竞争;证券市场的波动;公众对迷幻药物医疗用途的看法和看法不一致;对成瘾市场规模的预期;以及监管或政治变革。提醒读者,上述因素清单并未详尽列出可能影响前瞻性陈述的因素。因此,读者不应过分依赖前瞻性陈述。本新闻稿中的前瞻性陈述仅代表截至本新闻稿发布之日或此类陈述中规定的一个或多个日期。
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at . The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
投资者请注意,任何此类陈述都不能保证未来的表现,实际业绩或发展可能与前瞻性信息中的预测存在重大差异。有关该公司的更多信息,鼓励投资者在SEDAR上查看公司的公开文件,网址为。除法律要求外,公司不打算或义务更新或修改任何前瞻性信息,无论是由于新信息、未来事件还是其他原因。
Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com
416-270-9566
投资者查询:
安东尼·坦尼森,Awakn Life Sciences首席执行官
anthony.tennyson@awaknlifesciences.com
416-270-9566
译文内容由第三方软件翻译。