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Indivior Positioned To Profit If Aelis Farma's Study Of Cannabis Use Disorder Succeeds
Indivior Positioned To Profit If Aelis Farma's Study Of Cannabis Use Disorder Succeeds
Indivior PLC (OTCPK:INVVY) (LON:INDV) announces the enrollment of the first patient in the Phase 2b study of AEF0117 for the treatment of cannabis use disorder (CUD). This follows less than a year after Indivior and Aelis Farma announced a strategic collaboration that includes an exclusive option and license agreement for the global rights to AEF0117, a first-in-class synthetic signaling specific inhibitor ("SSI") engineered to inhibit the cannabinoid type 1 ("CB1") receptor ("CB1-SSI").
"Following the promising results of a Phase 2a study showing that AEF0117 reduced the subjective effects of cannabis and cannabis self-administration in subjects with moderate to severe CUD, this Phase 2b clinical trial aims at demonstrating the efficacy, tolerability and safety of AEF0117 for the treatment of CUD," stated Christian Heidbreder, Ph.D., chief scientific officer at Indivior.
"Excessive cannabis use and its related disorders have become an increasing societal concern. Roughly 200 million people used cannabis in 2019 representing 4% of the global population. In the US, 49.6 million people aged 12 or older used cannabis in 2020 and 14.2 million people had a CUD in the past year during the same period."
Phase 2b, which will be conducted by Aelis Farma, is a randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study in treatment-seeking subjects with moderate to severe CUD.
The primary objective of the study is to demonstrate that AEF0117 (0.1, 0.3, or 1 mg once a day for 12 weeks) induces a greater proportion of subjects with a response of ≤1 day of cannabis use per week compared to placebo. The proportion of subjects that reach various levels of reduction of use and how this influences their quality of life will also be investigated.
The initiation of this Phase 2b trial represents a key development in the company's pipeline, which upon completion would enable AEF0117 to move forward into a Phase 3 study in subjects with CUD.
The United Nations recently estimated that the number of cannabis users increased by nearly 18% over the past decade and that cannabis products almost quadrupled in strength in the US and doubled in Europe in the last two decades (2002-2019).D9-THC, the main psychoactive component in cannabis, is responsible for the development of mental health disorders in long-term, heavy users of cannabis.
Photo: Courtesy of PRNewsfoto/Indivior
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Indivior PLC (OTCPK:INVVY) (LON:INDV) announces the enrollment of the first patient in the Phase 2b study of AEF0117 for the treatment of cannabis use disorder (CUD). This follows less than a year after Indivior and Aelis Farma announced a strategic collaboration that includes an exclusive option and license agreement for the global rights to AEF0117, a first-in-class synthetic signaling specific inhibitor ("SSI") engineered to inhibit the cannabinoid type 1 ("CB1") receptor ("CB1-SSI").
分割器PLC(OTCPK:INVVY)(LON:INV)宣布2b期研究中的第一名患者入选的AEF0117 用于治疗大麻使用障碍(CUD)。这发生在Indior和Indior之后不到一年的时间艾丽斯·法玛宣布了一项战略合作,其中包括AEF0117全球权利的独家选择权和许可协议,AEF0117是一种一流的合成信号特异性抑制剂(SSI),设计用于抑制大麻素1型(CB1)受体(CB1-SSI)。
"Following the promising results of a Phase 2a study showing that AEF0117 reduced the subjective effects of cannabis and cannabis self-administration in subjects with moderate to severe CUD, this Phase 2b clinical trial aims at demonstrating the efficacy, tolerability and safety of AEF0117 for the treatment of CUD," stated Christian Heidbreder, Ph.D., chief scientific officer at Indivior.
“在2a期研究显示AEF0117减少了大麻和大麻自身给药对中重度CUD患者的主观影响后,这项2b期临床试验旨在证明AEF0117治疗CUD的有效性、耐受性和安全性,”他说。克里斯蒂安·海德布雷德博士,Indior的首席科学官。
"Excessive cannabis use and its related disorders have become an increasing societal concern. Roughly 200 million people used cannabis in 2019 representing 4% of the global population. In the US, 49.6 million people aged 12 or older used cannabis in 2020 and 14.2 million people had a CUD in the past year during the same period."
“过度吸食大麻及相关疾病已成为一个日益严重的社会问题。2019年约有2亿人吸食大麻,占全球人口的4%。在美国,2020年有4960万12岁及以上的人吸食大麻,而去年同期有1420万人吸食大麻。”
Phase 2b, which will be conducted by Aelis Farma, is a randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study in treatment-seeking subjects with moderate to severe CUD.
阶段2b将由Aelis Farma进行,这是一项随机、双盲、安慰剂对照、4组、平行组、前瞻性、多中心研究,针对患有中度至重度CUD的寻求治疗的受试者。
The primary objective of the study is to demonstrate that AEF0117 (0.1, 0.3, or 1 mg once a day for 12 weeks) induces a greater proportion of subjects with a response of ≤1 day of cannabis use per week compared to placebo. The proportion of subjects that reach various levels of reduction of use and how this influences their quality of life will also be investigated.
这项研究的主要目标是证明与安慰剂相比,AEF0117(0.1、0.3或1毫克每天一次,持续12周)与安慰剂相比,导致每周使用大麻1天的受试者的≤反应比例更高。还将调查达到不同程度减少使用的受试者的比例,以及这如何影响他们的生活质量。
The initiation of this Phase 2b trial represents a key development in the company's pipeline, which upon completion would enable AEF0117 to move forward into a Phase 3 study in subjects with CUD.
这项2b阶段试验的启动代表着该公司正在进行的一项关键进展,一旦完成,将使AEF0117能够进入针对CUD受试者的第三阶段研究。
The United Nations recently estimated that the number of cannabis users increased by nearly 18% over the past decade and that cannabis products almost quadrupled in strength in the US and doubled in Europe in the last two decades (2002-2019).D9-THC, the main psychoactive component in cannabis, is responsible for the development of mental health disorders in long-term, heavy users of cannabis.
联合国最近估计过去十年(2002-2019年),吸食大麻的人数增加了近18%,大麻产品在美国几乎翻了两番,在欧洲翻了一番。D9-THC是大麻中的主要精神活性成分,对长期大量吸食大麻者的精神健康障碍的发展负有责任。
Photo: Courtesy of PRNewsfoto/Indivior
图片来源:PRNewsFoto/Indior提供
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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