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Adial Pharmaceuticals Granted Key Patent From the United States Patent and Trademark Office

Adial Pharmaceuticals Granted Key Patent From the United States Patent and Trademark Office

Adial Pharmicals 獲得了美國專利和商標局的關鍵專利
GlobeNewswire ·  04/22 20:30

GLEN ALLEN, Va., April 22, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced patent number 11957664 was issued April 16, 2024 by the United States Patent and Trademark Office. This patent expands Adial's intellectual property protection and covers the combination of the Company's proprietary genetic diagnostic to identify patients with specific genotypes for genetically targeted treatment of alcohol use disorder (AUD) and other drug dependencies, such as opioid use disorder (OUD), with the Company's lead investigational new drug product AD04.

弗吉尼亞州格倫艾倫,2024年4月22日(環球新聞專線)——專注於開發治療和預防成癮及相關疾病療法的臨床階段生物製藥公司艾迪爾製藥公司(納斯達克股票代碼:ADIL)(“Adial” 或 “公司”)今天宣佈,美國專利商標局於2024年4月16日發佈了編號爲11957664的專利。該專利擴大了Adial的知識產權保護,涵蓋了該公司專有的基因診斷與該公司主要研究新藥產品AD04相結合,該診斷旨在識別具有特定基因型的患者,用於酒精使用障礙(AUD)和其他藥物依賴的基因靶向治療,例如阿片類藥物使用障礙(OUD)。

Cary Claiborne, CEO of Adial, commented, "We are proud to have secured this new patent, which covers important aspects of the combination of our proprietary genetic diagnostic and AD04 to treat AUD, OUD, and other drug dependencies. Importantly, we have identified specific genotypes that have responded with clinically meaningful changes in drinking behavior compared to placebo in the AD04 post hoc analysis, which represents an addressable market of approximately $40 billion in the U.S. alone. We believe our unique personalized approach can offer new hope to the millions affected by AUD, OUD and other addictive disorders such as obesity and gambling."

Adial首席執行官Cary Claiborne評論說:“我們很自豪能夠獲得這項新專利,該專利涵蓋了我們專有的基因診斷與AD04相結合以治療AUD、OUD和其他藥物依賴的重要方面。重要的是,在AD04事後分析中,與安慰劑相比,我們已經確定了特定的基因型,這些基因型的飲酒行爲發生了具有臨床意義的變化,僅在美國就有約400億美元的潛在市場。我們相信,我們獨特的個性化方法可以爲數百萬受澳元、OUD和其他成癮性疾病(例如肥胖和賭博)影響的患者帶來新的希望。”

About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company's lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company's ONWARD pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company's companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at .

關於阿迪爾製藥公司
Adial Pharmaceuticals是一家臨床階段的生物製藥公司,專注於開發成癮和相關疾病的治療方法。該公司的主要研究性新藥產品AD04是一種基因靶向血清素-3受體拮抗劑,用於治療重度飲酒患者酒精使用障礙(AUD),最近在該公司ONWARD的關鍵性3期臨床試驗中進行了研究,該試驗旨在對使用公司的伴隨診斷基因測試確定的具有某些靶標基因型的受試者可能治療澳元。ONWARD在減少大量飲酒患者的飲酒量方面顯示出令人鼓舞的結果,沒有明顯的安全性或耐受性問題。AD04還被認爲有可能治療其他成癮性疾病,例如阿片類藥物使用障礙、賭博和肥胖。其他信息可在以下網址獲得。

Forward-Looking Statements

前瞻性陳述

This communication contains certain "forward-looking statements" within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans" and similar expressions or future or conditional verbs such as "will," "should," "would," "may" and "could" are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the addressable market for AD04 representing approximately $40 billion in the U.S. alone, the Company's unique personalized approach offering new hope to the millions affected by AUD, OUD and other addictive disorders such as obesity and gambling and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

本通信包含美國聯邦證券法所指的某些 “前瞻性陳述”。此類陳述基於各種事實,並利用許多重要假設得出,並受已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致實際業績、業績或成就與此類前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在重大差異。前後跟或以其他方式包含 “相信”、“期望”、“預期”、“打算”、“項目”、“估計”、“計劃” 等類似表達方式或未來或條件動詞(如 “將”、“應該”、“將”、“可能” 和 “可能”)的陳述在本質上通常是前瞻性的,而不是歷史事實,儘管並非所有前瞻性陳述都包括前述內容。前瞻性陳述包括有關AD04潛在市場的陳述,僅在美國就有約400億美元,該公司獨特的個性化方法爲數百萬受澳元、OUD和其他成癮性疾病(例如肥胖和賭博)影響的患者帶來了新的希望,以及AD04治療阿片類藥物使用障礙、賭博和肥胖等其他成癮性疾病的潛力。此處包含的任何前瞻性陳述都反映了我們當前的觀點,它們涉及某些風險和不確定性,其中包括:我們推行監管戰略的能力、推進持續合作討論的能力、我們獲得監管部門批准以實現候選產品商業化或遵守現行監管要求的能力、我們開發戰略合作機會和維持合作的能力、我們獲得或維持爲研究提供資金所必需的資本或補助金的能力,以及開發活動,我們留住關鍵員工或維持在納斯達克上市的能力,我們按時完成臨床試驗並按預期取得預期結果和收益的能力,與我們針對特定適應症推廣或商業化候選產品的能力相關的監管限制,候選產品在市場上的接受以及我們產品的成功開發、營銷或銷售,我們維持許可協議的能力,專利資產的持續維護和增長以及我們的能力留住我們的關鍵員工或維持我們在納斯達克的上市。不應將這些風險解釋爲詳盡無遺,應與我們在截至2023年12月31日止年度的10-K表年度報告、隨後的10-Q表季度報告以及向美國證券交易委員會提交的8-K表最新報告中的其他警示性聲明一起閱讀。任何前瞻性陳述僅代表其最初發表之日。除非法律要求,否則我們沒有義務公開更新或修改任何前瞻性陳述,無論是由於新信息、未來事件、情況變化還是其他原因。

Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com

聯繫人:
克雷森多通訊有限責任公司
大衛·沃爾德曼/亞歷山德拉·席爾特
電話:212-671-1020
電子郵件:adil@crescendo-ir.com


譯文內容由第三人軟體翻譯。


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