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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)宣佈2b期研究中的第一名患者入選的AEF0117 用於治療大麻使用障礙(CUD)。這發生在Indior和Indior之後不到一年的時間艾麗斯·法瑪宣佈了一項戰略合作,其中包括AEF0117全球權利的獨家選擇權和許可協議,AEF0117是一種一流的合成信號特異性抑制劑(SSI),設計用於抑制大麻素1型(CB1)受體(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期研究顯示AEF0117減少了大麻和大麻自身給藥對中重度CUD患者的主觀影響後,這項2b期臨牀試驗旨在證明AEF0117治療CUD的有效性、耐受性和安全性,”他説。克里斯蒂安·海德佈雷德博士,Indior的首席科學官。
"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."
“過度吸食大麻及相關疾病已成為一個日益嚴重的社會問題。2019年約有2億人吸食大麻,佔全球人口的4%。在美國,2020年有4960萬12歲及以上的人吸食大麻,而去年同期有1420萬人吸食大麻。”
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.
階段2b將由Aelis Farma進行,這是一項隨機、雙盲、安慰劑對照、4組、平行組、前瞻性、多中心研究,針對患有中度至重度CUD的尋求治療的受試者。
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.
這項研究的主要目標是證明與安慰劑相比,AEF0117(0.1、0.3或1毫克每天一次,持續12周)與安慰劑相比,導致每週使用大麻1天的受試者的≤反應比例更高。還將調查達到不同程度減少使用的受試者的比例,以及這如何影響他們的生活質量。
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.
這項2b階段試驗的啟動代表着該公司正在進行的一項關鍵進展,一旦完成,將使AEF0117能夠進入針對CUD受試者的第三階段研究。
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.
聯合國最近估計過去十年(2002-2019年),吸食大麻的人數增加了近18%,大麻產品在美國幾乎翻了兩番,在歐洲翻了一番。D9-THC是大麻中的主要精神活性成分,對長期大量吸食大麻者的精神健康障礙的發展負有責任。
Photo: Courtesy of PRNewsfoto/Indivior
圖片來源:PRNewsFoto/Indior提供
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moomoo是Moomoo Technologies Inc.公司提供的金融資訊和交易應用程式。
在美國,moomoo上的投資產品和服務由Moomoo Financial Inc.提供,一家受美國證券交易委員會(SEC)監管的持牌主體。 Moomoo Financial Inc.是金融業監管局(FINRA)和證券投資者保護公司(SIPC)的成員。
在新加坡,moomoo上的投資產品和服務是通過Moomoo Financial Singapore Pte. Ltd.提供,該公司受新加坡金融管理局(MAS)監管(牌照號碼︰CMS101000) ,持有資本市場服務牌照 (CMS) ,持有財務顧問豁免(Exempt Financial Adviser)資質。本內容未經新加坡金融管理局的審查。
在澳大利亞,moomoo上的金融產品和服務是通過Futu Securities (Australia) Ltd提供,該公司是受澳大利亞證券和投資委員會(ASIC)監管的澳大利亞金融服務許可機構(AFSL No. 224663)。請閱讀並理解我們的《金融服務指南》、《條款與條件》、《隱私政策》和其他披露文件,這些文件可在我們的網站 https://www.moomoo.com/au中獲取。
在加拿大,透過moomoo應用程式提供的僅限訂單執行的券商服務由Moomoo Financial Canada Inc.提供,並受加拿大投資監管機構(CIRO)監管。
在馬來西亞,moomoo上的投資產品和服務是透過Moomoo Securities Malaysia Sdn. Bhd. 提供,該公司受馬來西亞證券監督委員會(SC)監管(牌照號碼︰eCMSL/A0397/2024) ,持有資本市場服務牌照 (CMSL) 。本內容未經馬來西亞證券監督委員會的審查。
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., 是關聯公司。
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