Clearmind Medicine Obtains IND Approval From the FDA to Start the Phase I/IIa Clinical Trial With Its Innovative Treatment for Alcoholism
Clearmind Medicine Obtains IND Approval From the FDA to Start the Phase I/IIa Clinical Trial With Its Innovative Treatment for Alcoholism
Vancouver, Canada, July 16, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) ("Clearmind" or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule, allowing the Company to proceed with a Phase I/IIa clinical trial in the United States for treating patients with alcohol use disorder (AUD). While the Phase I/IIa clinical trial was already approved in Israel, clearance from the FDA will allow the trial to be initiated in the US.
加拿大溫哥華,2024年7月16日(環球新聞專線)——Clearmind Medicine Inc.(納斯達克股票代碼:CMND)(FSE:CWY0)(“Clearmind” 或 “公司”)是一家臨床階段的生物技術公司,專注於發現和開發新型迷幻藥衍生療法,以解決治療不足的重大健康問題,今天宣佈,美國食品藥品監督管理局(FDA)已批准該公司其專有的基於 MEAI(5-甲氧基-2-氨基吲哚烷)CMND-100 口服膠囊的研究性新藥(IND)申請,使公司得以進行 I/IIa 期臨床試驗在美國進行的治療酒精使用障礙(AUD)患者的試驗。儘管I/IIa期臨床試驗已經在以色列獲得批准,但獲得美國食品藥品管理局的批准將允許該試驗在美國啓動。
The Phase I/IIa clinical trial is a multinational, multi-center, single and multiple dose, tolerability, safety and pharmacokinetic trial of CMND-100 in healthy volunteers and AUD subjects.
I/IIa 期臨床試驗是一項針對健康志願者和 AUD 受試者的 CMND-100 的跨國、多中心、單劑量和多劑量、耐受性、安全性和藥代動力學試驗。
The Company has signed agreements to perform the Phase I/IIa clinical trial in leading universities in the United States, Yale School of Medicine's and the Johns Hopkins University School of Medicine. The Israeli trial will be conducted at the IMCA in the Tel Aviv suburb of Ramat Gan.
該公司已簽署協議,將在美國頂尖大學、耶魯醫學院和約翰·霍普金斯大學醫學院進行I/IIa期臨床試驗。以色列的審判將在特拉維夫郊區拉馬特甘的IMCA進行。
"The FDA's IND approval for CMND-100 marks a significant step forward in addressing the critical unmet medical needs in AUD, a disease currently lacking effective treatments. Excessive alcohol use is a leading preventable cause of death in the United States, affecting millions of patients and their families. We believe in the potential of our treatment to improve millions of lives in a safe, easy, and efficient way," said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. "Approval to start our first-in-human clinical trial of CMND-100 in the United States represents an important step towards validation of our approach for the treatment of this devastating addiction. In pre-clinical studies, our proprietary drug demonstrated marked efficacy with a good safety profile. We are eager to bring this potential treatment option to patients".
“美國食品和藥物管理局對 CMND-100 的IND批准標誌着在解決澳元未滿足的關鍵醫療需求方面向前邁出了重要一步,澳元是一種目前缺乏有效治療的疾病。在美國,過量飲酒是可預防的主要死亡原因,影響着數百萬患者及其家屬。我們相信我們的治療有可能以安全、簡單和有效的方式改善數百萬人的生活。” Clearmind Medicine首席執行官阿迪·祖洛夫-沙尼博士說。“批准我們在美國啓動首個 CMND-100 人體臨床試驗,這是朝着驗證我們治療這種毀滅性成癮的方法邁出的重要一步。在臨床前研究中,我們的專有藥物顯示出明顯的療效和良好的安全性。我們渴望爲患者帶來這種潛在的治療選擇”。
The primary endpoint of the Phase I/IIa clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics / pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary endpoint is to evaluate preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial.
I/IIa 期臨床試驗的主要終點是確定健康受試者和 AUD 患者單次和重複劑量 CMND-100 的可耐受劑量並描述其安全性和藥代動力學/藥效學。次要終點是評估 CMND-100 在減少中度至重度澳元患者飲酒模式和渴望方面的初步療效。將給予口服膠囊,接受這些口服膠囊治療的受試者將在臨床試驗期間報告其飲酒模式和對酒精的渴望。
The active ingredient in CMND-100 is MEAI, an innovative, psychoactive and non-hallucinogenic molecule that has been reported to reduce the desire to consume alcoholic beverages, while exerting a slight euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors 5-HT1a and 5-HT2a. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C, as well as the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT). These receptors and transporters are believed to participate in mediating alcohol drinking behavior and could constitute important molecular targets for interventions that target drugs subject to abuse, such as alcohol.
CMND-100 中的活性成分是 MEAI,這是一種創新的、具有精神活性的非致幻分子,據報道,它可以減少飲用酒精飲料的慾望,同時產生輕微的類似酒精的愉悅體驗。發現 MEAI 與血清素能受體 5-HT1a 和 5-HT2A 相互作用。血清素能系統被認爲在調節酒精攝入量、獎勵、偏好和依賴方面起着關鍵作用。還發現MEAI與α-2-腎上腺素能受體α2A、α20和α2C以及多巴胺(DAT)、去甲腎上腺素(NET)和血清素(SERT)的質膜單胺轉運蛋白相互作用。據信,這些受體和轉運蛋白參與介導酒精飲酒行爲,並可能構成針對酒精等易濫用藥物的干預措施的重要分子靶標。
About Clearmind Medicine Inc.
Clearmind Medicine Inc
Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.
Clearmind 是一家臨床階段的迷幻製藥生物技術公司,專注於發現和開發新的迷幻衍生療法,以解決廣泛存在且服務不足的健康問題,包括酒精使用障礙。其主要目標是研究和開發以迷幻藥爲基礎的化合物,並嘗試將其作爲管制藥物、食品或補充劑進行商業化。
The Company's intellectual portfolio currently consists of eighteen patent families including 28 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.
該公司的知識組合目前由十八個專利家族組成,其中包括28項已獲授權的專利。該公司打算在必要時爲其化合物尋求更多專利,並將在收購更多知識產權以建立其產品組合方面保持機會主義。
Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol "CWY0."
Clearmind的股票在納斯達克上市交易,股票代碼爲 “CMND”,法蘭克福證券交易所的股票代碼爲 “CWY0”。
For further information visit: or contact:
欲了解更多信息,請訪問:或聯繫:
Investor Relations
invest@clearmindmedicine.com
投資者關係
invest@clearmindmedicine.com
Telephone: (604) 260-1566
US: CMND@crescendo-ir.com
電話:(604) 260-1566
美國:CMND@crescendo-ir.com
General Inquiries
一般查詢
Info@Clearmindmedicine.com
Info@Clearmindmedicine.com
Forward-Looking Statements:
前瞻性陳述:
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses how the FDA's IND approval for CMND-100 marks a significant step forward in addressing the critical unmet medical needs in AUD and its belief in the potential of its treatment to improve millions of lives in a safe, easy, and efficient way. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's annual report on Form 20-F for the fiscal year ended October 31, 2023 filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.
本新聞稿包含《私人證券訴訟改革法》和其他證券法所指的 “前瞻性陳述”。諸如 “期望”、“預期”、“打算”、“計劃”、“相信”、“尋求”、“估計” 之類的詞語以及此類詞語的類似表述或變體旨在識別前瞻性陳述。例如,該公司在討論美國食品藥品管理局對 CMND-100 的IND批准如何標誌着在解決澳元未得到滿足的關鍵醫療需求方面向前邁出的重要一步,以及該公司對澳元治療有可能以安全、簡單和有效的方式改善數百萬人生活的信念時使用了前瞻性陳述。前瞻性陳述不是歷史事實,而是基於管理層當前的預期、信念和預測,從本質上講,其中許多預期、信念和預測本質上是不確定的。這些期望、信念和預測是本着誠意表達的。但是,無法保證管理層的預期、信念和預測將得到實現,實際業績可能與前瞻性陳述中所表達或表明的結果存在重大差異。前瞻性陳述受風險和不確定性的影響,這些風險和不確定性可能導致實際表現或結果與前瞻性陳述中表達的表現或結果存在重大差異。有關影響公司的風險和不確定性的更詳細描述,請參閱公司不時向美國證券交易委員會(“SEC”)提交的報告,包括但不限於公司向美國證券交易委員會提交的截至2023年10月31日財年的20-F表年度報告中詳述的風險。前瞻性陳述僅代表陳述發表之日。除非適用的證券法要求,否則公司沒有義務更新前瞻性陳述以反映實際業績、後續事件或情況、假設變化或影響前瞻性信息的其他因素的變化。如果公司確實更新了一項或多項前瞻性陳述,則不應推斷公司將對這些陳述或其他前瞻性陳述進行更多更新。爲方便起見,我們提供了網站引用和鏈接,此類網站上包含的信息未以引用方式納入本新聞稿。Clearmind 對第三方網站的內容不承擔任何責任。