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Cybin Approved For First In-Human Dosing Of DMT Molecule CYB004, Milestone For Anxiety Disorder Treatment
Cybin Approved For First In-Human Dosing Of DMT Molecule CYB004, Milestone For Anxiety Disorder Treatment
Cybin Inc. (NYSE: CYBN) announced that it has received approval from an independent ethics committee in the Netherlands to begin the first in-human dosing of its proprietary deuterated N, N-dimethyltryptamine (DMT) molecule CYB004 through a protocol amendment to its ongoing CYB004-E Phase 1 trial.
Why It Matters
This clinical advancement marks the first time a deuterated DMT molecule will be evaluated in humans and further reduces Cybin's time-to-clinic with CYB004. Cybin plans to evaluate CYB004 for the treatment of generalized anxiety disorder with or without major depressive disorder.
"This is a major milestone for our CYB004 program and for better understanding the potential therapeutic benefits of our proprietary deuterated DMT molecule for the treatment of generalized anxiety disorder," said Doug Drysdale, Cybin's CEO. "The ability to evaluate our novel CYB004 molecule in humans at this early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 in addition to what we have already learned through our study of DMT. We expect to apply these findings to optimize dosing and delivery of CYB004 in future clinical trials, which supports our mission to bring this new investigational therapy to patients as quickly as possible."
The Phase 1 CYB004-E trial is being conducted at the Centre for Human Drug Research in the Netherlands and is the largest-ever Phase 1 DMT trial conducted to date.
DMT And CYB004
In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer more convenient dosing methods via inhaled, subcutaneous, or intramuscular routes of administration.
In February 2022, Cybin secured a U.S. composition of matter patent covering CYB004, which provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.
"With strong intellectual property in place and promising preclinical data, we believe we have a solid clinical development path forward for CYB004. We will continue to focus our research on identifying the most convenient routes of administration while also maintaining an optimal therapeutic profile for this important molecule," concluded Drysdale.
Cybin Inc. (NYSE: CYBN) announced that it has received approval from an independent ethics committee in the Netherlands to begin the first in-human dosing of its proprietary deuterated N, N-dimethyltryptamine (DMT) molecule CYB004 through a protocol amendment to its ongoing CYB004-E Phase 1 trial.
Cybin 公司 紐約證券交易所代碼:CYBN)宣布,已獲得荷蘭獨立倫理委員會的批准,通過對其正在進行的 CYB004-E 1 期試驗的協議修訂,開始對其專有的代 N,N-二甲基色氨酸(DMT)分子 CYB004 進行的首次人體給藥。
Why It Matters
為什麼它很重要
This clinical advancement marks the first time a deuterated DMT molecule will be evaluated in humans and further reduces Cybin's time-to-clinic with CYB004. Cybin plans to evaluate CYB004 for the treatment of generalized anxiety disorder with or without major depressive disorder.
這種臨床進步標誌著將首次在人類中評估分的 DMT 分子,並進一步縮短 Cybin 的診所時間與 CYB004。Cybin 計劃評估 CYB004,用於治療有或沒有重大抑鬱症的廣泛性焦慮症。
"This is a major milestone for our CYB004 program and for better understanding the potential therapeutic benefits of our proprietary deuterated DMT molecule for the treatment of generalized anxiety disorder," said Doug Drysdale, Cybin's CEO. "The ability to evaluate our novel CYB004 molecule in humans at this early stage is a significant achievement in clinical development and will provide important insight into the pharmacokinetic and pharmacodynamic properties of CYB004 in addition to what we have already learned through our study of DMT. We expect to apply these findings to optimize dosing and delivery of CYB004 in future clinical trials, which supports our mission to bring this new investigational therapy to patients as quickly as possible."
「這是我們 CYB004 計劃的一個重要里程碑,也是為了更好地理解我們專有的代 DMT 分子對治療廣泛性焦慮症的潛在治療益處,」說 道格·德里斯代爾,賽賓的首席執行官。「在這個早期階段評估我們新穎的 CYB004 分子的能力是臨床發展的重要成就,除了我們已經通過 DMT 研究了解到的知識之外,還將對 CYB004 的藥代動力學和藥效學特性提供重要的見解。我們希望在未來的臨床試驗中應用這些研究結果來優化 CYB004 的劑量和遞送,這對我們的使命是盡快將這種新的研究治療帶給患者提供支持。」
The Phase 1 CYB004-E trial is being conducted at the Centre for Human Drug Research in the Netherlands and is the largest-ever Phase 1 DMT trial conducted to date.
第一階段 CYB004-E 試驗正在荷蘭的人類藥物研究中心進行,是迄今為止最大規模的第一階段 DMT 試驗。
DMT And CYB004
DMT 及 CYB004
In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004 has the potential to overcome the limitations of DMT. Based on preclinical studies, CYB004 has demonstrated an improved bioavailability and pharmacokinetic profile in comparison to DMT when administered via intravenous and inhaled routes. These studies also demonstrated that IV CYB004 has a longer duration of effect compared to DMT, indicating the potential to extend the therapeutic window and provide better dose optimization. By maximizing CYB004 as a deuterated molecule and improving upon the bioavailability of DMT, CYB004 has the potential to offer more convenient dosing methods via inhaled, subcutaneous, or intramuscular routes of administration.
在其規則形式, DMT 是一個不穩定的分子在體內迅速代謝, 這顯著降低了其生物利用度. CYB004 具有克服 DMT 限制的潛力。根據臨床前研究,與 DMT 相比,通過靜脈注射和吸入路線施用時,CYB004 已經證明了改善的生物利用度和藥代動力學特徵。這些研究還表明,與 DMT 相比,IV CYB004 具有更長的效果持續時間,這表明有可能擴展治療窗口並提供更好的劑量優化。通過將 CYB004 作為分子最大化並提高 DMT 的生物利用度,CYB004 有可能通過吸入,皮下或肌內管理路線提供更方便的給藥方法。
In February 2022, Cybin secured a U.S. composition of matter patent covering CYB004, which provides patent protection through 2041. The patent covers a range of deuterated forms of DMT and protects CYB004 as a putative new chemical entity.
2022 年 2 月,Cybin 獲得了涵蓋 CYB004 的美國物質組成專利,該專利在 2041 年之前提供專利保護。該專利涵蓋了一系列的 DMT 代形式,並保護 CYB004 作為假定的新化學實體。
"With strong intellectual property in place and promising preclinical data, we believe we have a solid clinical development path forward for CYB004. We will continue to focus our research on identifying the most convenient routes of administration while also maintaining an optimal therapeutic profile for this important molecule," concluded Drysdale.
憑藉強大的智慧財產權和有前途的臨床前資料,我們相信我們為 CYB004 擁有堅實的臨床發展路徑。我們將繼續專注於確定最方便的管理途徑,同時還保持這個重要分子的最佳治療特徵,」Drysdale 總結道。
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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。
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