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.
多倫多,安大略省-(Newsfile Corp. - 2024年10月22日)- Awakn生命科學公司(cse: AWKN)(OTCQB: AWKNF)(FSE: 954)("Awakn"或"公司"), 一家臨床生物技術公司,正在開發治療物質使用和心理健康障礙的醫藥,宣佈開設四個額外的臨床試驗站點:蘇塞克斯大學醫院NHS基金會信託;南倫敦和莫茲利醫院NHS基金會信託;大曼徹斯特精神衛生NHS基金會信託;以及普利茅斯大學醫院NHS信託。這將使「MORE-KARE」第3階段AWKN-001試驗的總活動試驗站點達到7個。
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是一種用於治療嚴重AUD的研究性、新型藥物輔助治療,由N-甲基-D-天冬氨酸受體調節藥物(氯胺酮)與嚴重AUD的手冊化心理社會支持結合靜脈注射(IV)組成。
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,即關於減少酒精復發的氯胺酮多中心調查,由英國醫學研究委員會(MRC)和國家衛生及護理研究所(NIHR)的合作資助,以及Awakn生命科學公司。該研究由艾克塞特大學臨床試驗單位管理。
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.
第3階段試驗旨在評估AWKN-001的單個治療週期的療效。參與者將被隨機分配到一個試驗組,接受不同劑量的氯胺酮輸注,以及來自試驗治療師的心理社會支持會話。每位參與者的具體劑量和心理支持類型將由計算機隨機分配。參與者和研究團隊都將被矇蔽以防止知道分配的劑量/支持。
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首席執行官安東尼·坦尼森(Anthony Tennyson)評論道:「試驗站點的擴展標誌着我們在爲AUD的創新治療提供迫切需要的里程碑。我們相信AWKN-001有潛力改變英國嚴重酒精使用障礙患者的護理標準,爲他們提供新穎、更有效的治療途徑。」
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的首席研究官David Nutt教授補充道:"開設這些額外的研究站點加速了我們收集健全臨床數據的能力,這對於將這一突破性治療帶給更多患者至關重要。在英國領先的研究機構的支持下,我們有望證明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.
這項研究是迄今爲止規模最大的關於利用氯胺酮輔助治療AUD的研究。總試驗成本估計爲£240萬/加幣420萬,Awakn貢獻了£80萬/加幣140萬。該試驗正在英國的八個國民健康服務(NHS)站點進行。
About AWKN-001
關於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是一種針對嚴重AUD的調查性新型藥物輔助治療,由一種N-甲基-D-天冬氨酸受體調節藥物(氯胺酮)與在英國市場上僅施用的手動化心理社會支持結合靜脈內(IV)途徑給藥。
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.
二期試驗已成功完成,證實了療效,在治療後的6個月內,平均戒斷率達到86%,而前期試驗僅有2%,重度飲酒日數減少50%,高於安慰劑。
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.
由埃克塞特大學進行的第3期臨床試驗("MORE KARE")正在進行。該試驗得到了英國國家健康研究所(NIHR)和醫學研究理事會(MRC)合作支持的療效與機制評估(EME)計劃共同資助,同時Awakn生命科學公司也參與支持。
About Awakn Life Sciences Corp.
關於Awakn Life Sciences Corp。
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生命科學公司是一家處於臨床階段的生物技術公司,開發針對物質濫用和心理健康障礙的治療藥物。Awakn目前重點關注AUD,這是一種影響到美國約2900萬成年人以及歐美關鍵市場的大約4000萬成年人的控件,當前的標準治療效果不佳。我們的目標是爲急需幫助的成癮患者提供突破性治療藥物,我們的策略着重於在多個渠道推廣我們的研發管線。
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About the University of Exeter
關於埃克塞特大學
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.
埃克塞特大學是這項臨床試驗的贊助商,整體試驗管理、數據管理和統計分析是與埃克塞特臨床試驗機構(埃克塞特大學)合作提供的。在埃克塞特大學,我們將教學卓越和高水平的學生滿意度與埃克塞特和康沃爾校區的世界級研究相結合。我們是領先的研究型大學協會「羅素團體」的成員。
About The National Institute for Health and Care Research (NIHR)
關於國家健康與護理研究所(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:
國家健康與護理研究所(NIHR)的使命是通過研究提高國民的健康和財富。我們通過以下方式實現這一目標:
- 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.
- 資助受益於英國國民保健服務、公共衛生和社會保健的高質量、及時的研究;
- 投資於世界級專業知識、設施和熟練的交付團隊,將發現轉化爲改進的治療和服務。
- 與患者、服務用戶、照顧者和社區合作,改善研究的相關性、質量和影響力;
- 吸引、培訓和支持最優秀的研究人員來解決複雜的醫療和社會護理挑戰;
- 與其他公共資助者、慈善機構和行業合作,幫助塑造一個具有凝聚力和全球競爭力的研究系統;
- 資助應用全球衛生研究和培訓,以滿足低收入和中等收入國家最貧困人群的需求。
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由英國衛生和社會風險部門資助。其在低收入和中等收入國家的工作主要通過英國政府的英國援助資助。
About the Medical Research Council
關於醫學研究理事會
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.
英國研究與創新醫學研究理事會站在科學發現的前沿,以改善人類健康。成立於1913年,應對結核病,MRC目前在各個健康領域投資納稅人的資金,致力於全球一些最優秀的醫學研究。三十三名MRC資助的研究人員獲得了諾貝爾獎,在各種學科領域取得了重要發現,如維生素、DNA的結構和吸菸與癌症之間的聯繫,以及開創性地使用隨機對照試驗,MRI掃描的發明,以及一組抗體的開發用於製造有史以來研發最成功的藥物。
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.
今天,受MRC資助的科學家正在應對21世紀面臨的一些重大健康問題,從與老齡化相關的慢性疾病不斷增加到由快速突變的微生物帶來的威脅。醫學研究理事會是英國研究與創新的一部分。
Notice Regarding Forward-Looking Information
關於前瞻性信息的通知
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.
本新聞稿中含有某些前瞻性信息和前瞻性聲明,如適用證券法所定義的那樣(以下統稱「前瞻性聲明」)。「前瞻性聲明」反映了關於未來事件或公司未來業績的目前期望或信念。除歷史事實之外,所有陳述均爲前瞻性聲明。常常但並非總是能夠通過使用諸如「計劃」、「預計」、「預計」、「預算」、「計劃」、「估計」、「繼續」、「預測」、「項目」、「預測」、「打算」、「 預售」或這些單詞和短語的變體或這些單詞和短語的否定,或者聲明某些行動,「事件」或「結果」「可能」,「可能」,「將」,「應該」,「可能」或「將要」被採取,發生或實現,包括涉及公司業務的聲明。所有前瞻性聲明,包括此處的所有聲明均受到本警示聲明的約束。
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.
儘管公司認爲此類聲明所表達的期望基於合理的假設,但這些聲明並不保證未來業績,實際結果或發展情況可能與陳述不同。存在某些因素可能導致實際結果與前瞻性信息有所不同。這些因素包括但不限於:宏觀經濟環境的波動;公司的業務計劃和戰略;公司能否在高度監管的業務中遵守所有適用政府法規;在某些司法管轄區中目標公司或項目的營運歷史有限或沒有營運歷史,且涉及當前被視爲非法活動的活動;法規變化;運營歷史有限;依賴管理層;需要獲取額外的融資;競爭;證券市場波動性;關於使用致幻藥物用於醫療方面的公衆意見和感知不一致;對戒癮市場規模的預期;以及監管或政治變化。讀者被警告,上述因素清單並非前瞻性聲明影響因素的窮盡清單,請勿過於依賴前瞻性聲明。本新聞稿中的前瞻性聲明僅反映發表日期或在該等聲明中指定的日期或日期。
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.
投資者需注意,此類陳述並不保證未來業績,實際結果或發展情況可能與前瞻性信息所述有所不同。有關公司的更多信息,投資者應鼓勵查閱該公司在SEDAR的公開申報文件。該公司聲明除了法律規定之外,沒有任何意圖或義務更新或修訂任何前瞻性信息。
Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com
416-270-9566
投資者查詢:
Awakn生命科學首席執行官Anthony Tennyson
anthony.tennyson@awaknlifesciences.com
416-270-9566
譯文內容由第三人軟體翻譯。