Study intended to optimize design elements needed for the upcoming US Pivotal Phase 3 studies
and support ongoing partnership discussions
Topline results expected in early Q4 2024
GLEN ALLEN, Va., June 05, 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, announced that the first patient has been dosed in a pharmacokinetics study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 10 drinks/drinking day). The study is expected to take 6 months to complete and is intended to produce data which will help the Company to optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study will also satisfy a requirement of the FDA guidance for the upcoming Phase 3 clinical trial of AD04.
Cary Claiborne, President and Chief Executive Officer of Adial commented, "Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study. Our goal is to obtain data we need to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA. Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the Phase 3 study design. This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 towards regulatory approval."
The pharmacokinetics study will involve two cohorts conducted consecutively and is expected to be completed in early Q4 2024. The single-center, relative bioavailability, open-label study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose taken twice daily of 0.33 mg with or without food against a reference standard product. This study will provide valuable information on the pharmacokinetic properties of AD04. The company expects to report topline results in early Q4 2024.
About AD04
AD04 (0.33mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol craving. This mode of action is distinct from, but complimentary to, the currently approved therapies for AUD. Post-hoc analyses of Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor experience substantial and clinically meaningful reductions in alcohol consumption. The specific mutations that appear to respond to AD04 are single nucleotide polymorphisms (SNPs) on rs1150226-AG ("AG") or rs1176713-GG ("GG") genotypes in the gene that encodes the 5-HT3A receptor subunit. These genes are thought to affect the binding of AD04 to the 5HT3 receptor and its function. Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo, demonstrating that it is extremely safe and tolerable.
Adial has already developed a companion diagnostic test (CDx) to identify the specific genotypes that benefit from AD04. This test was used in its Phase 3 ONWARD study, will be used in future clinical studies, and will be commercially available at the time of AD04's launch.
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 .
Forward-Looking Statements
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 pharmacokinetics study of AD04 taking 6 months to complete, the study producing data which will help the Company to optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD, the study enhancing the likelihood of success in the Company's upcoming Phase 3 trial, the study also providing data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA, engaging with the FDA in Q4 2024 to discuss the results of the study and obtain feedback to refine the Phase 3 study design, the meeting helping establish the final protocol and ensuring that it aligns with FDA expectations, further advancing AD04 towards regulatory approval, the study involving two cohorts conducted consecutively and being completed in early Q4 2024, enrolling up to 30 healthy adult volunteers, the study providing valuable information on the pharmacokinetic properties of AD04, including its absorption, distribution, metabolism, and excretion, as well as the effect of food on its bioavailability, reporting topline results in early Q4 2024 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 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 statement 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.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com
該研究旨在優化設計元素,以滿足即將到來的美國關鍵第三階段研究的要求
並支持正在進行的合作伙伴關係的討論
首要結果將於2024年第四季度初公佈
瓦吉尼亞州格倫艾倫,2024年6月5日(環球新聞社)——臨床階段生物製藥公司Adial Pharmaceuticals, Inc.(NASDAQ: ADIL)(“Adial”或“公司”)宣佈,首名患者接受了基因靶向、選擇性5-HT3拮抗劑治療藥物AD04的藥代動力學研究。該藥物旨在治療重度喝酒患者(定義爲每天飲酒次數<10次)的酒精使用障礙(AUD)。該研究預計要花費6個月左右完成,旨在產生數據,有助於公司優化AD04關鍵第三階段臨床試驗所需的研究設計元素。完成該研究還將滿足FDA指南對即將進行的AD04第三階段臨床試驗的要求。
Adial的總裁兼首席執行官Cary Claiborne評論道:“首名患者接受治療是一個重要的里程碑,標誌着該事先計劃和預算研究的臨床活動的開始。我們的目標是獲得所需的數據,以設計更精確和明智的第三階段試驗方案,包括評估最佳劑量方案,以最大限度地提高AD04對AUD患者的療效和安全性。完成該研究符合FDA提供的先前指導,並旨在增加我們即將進行的AD04第三階段試驗的成功機會。這項相對較短且低成本的研究也是我們推進正在進行的夥伴關係討論的關鍵要素。研究還將提供必要的數據,以支持AD04在FDA 505(b)(2)監管途徑下的批准申請。展望未來,我們計劃在2024年第四季度與FDA進行磋商,討論此藥代動力學研究的結果並獲得反饋,以進一步推進AD04向監管批准的進展。”
該藥代動力學研究將連續進行兩個隊列,預計將於2024年第四季度初完成。這項單中心、相對生物等效性、開放式研究將招募多達30名健康成年志願者,並比較口服0.33毫克AD04(每天兩次)在有無食物條件下的藥物動力學特徵與參考標準產品。該研究將提供有關AD04藥代動力學特性的有價值信息。公司預計將於2024年第四季度初公佈首要結果。
關於AD04
AD04(口服0.33毫克的順樂安定,每天兩次)作用於5HT3途徑,據信可以減少酒精渴求。這種作用機制不同於目前已批准的AUD療法,但與其相輔相成。Adial以前的臨床研究的後期分析表明,患有5HT3受體突變的患者會經歷明顯且具有臨床意義的飲酒量降低。對於AD04作出反應的具體突變被認爲是5-HT3A受體亞基在rs1150226-AG ('AG')或rs1176713-GG ('GG') 基因型的單核苷酸多態性(SNP)。這些基因被認爲會影響AD04與5HT3受體的結合和其功能。此外,在以前的兩項臨床試驗中,AD04與安慰劑有相似的不良事件,表明其極其安全和耐受。Adial已經開發出伴隨診斷檢測(CDx),用於確定受益於AD04的特定基因型。該檢測用於其第三階段ONWARD臨床試驗,將用於將來的臨床試驗,並將在AD04上市時商業提供。
AD04 (每日口服0.33毫克洛硫司瓊,早晚各服用一次) 作用於5-HT3途徑,有助於減少對酒精的渴求。這種作用方式不同於目前已批准的AUD治療方法,但是互補。Adial先前的臨床研究的事後分析表明,5-HT3受體突變的患者飲酒量大幅減少,具有臨床意義。似乎會對AD04產生反應的特定突變是編碼5-HT3A受體亞單位的rs1150226-AG(“AG”)或rs1176713-GG(“GG”)基因上的單核苷酸多態性(SNP)。這些基因被認爲會影響AD04結合到5-HT3受體及其功能。此外,在先前的兩項臨床試驗中,AD04與安慰劑的不良事件相似,表明其極其安全和可耐受。
Adial已經開發出伴隨診斷檢測(CDx),用於確定受益於AD04的特定基因型。該檢測用於其第三階段ONWARD臨床試驗,將用於將來的臨床試驗,並將在AD04上市時商業提供。
關於Adial Pharmaceuticals,Inc.
Adial Pharmaceuticals是一家專注於開發成癮和相關疾病治療方法的臨床階段生物製藥公司。公司的首個新藥研究產品AD04是一種基因靶向,選擇性5-HT3受體拮抗劑,治療重度喝酒患者的酒精使用障礙,並在公司的ONWARD關鍵第三階段臨床試驗中對某些目標基因型的主題AUD進行了研究,在重度飲酒患者中減少飲酒,沒有明顯的安全或耐受性問題。此外,AD04還被認爲具有治療其他成癮障礙,如阿片類物質使用障礙、博彩和肥胖病的潛力。有關更多信息,請訪問 。
Adial Pharmaceuticals是一家臨床階段生物製藥公司,專注於治療成癮及相關疾病的研發。該公司的主要新藥研究產品AD04是一種基因靶向、三環素受體拮抗劑,用於治療酒精使用障礙(AUD)的重度飲酒患者,並最近在該公司的ONWARD關鍵性第3期臨床試驗中進行了研究,以期治療具有某些目標基因型的AUD患者,該試驗使用了該公司的伴隨診斷基因檢測。ONWARD在減少重度飲酒患者的飲酒方面展示了有希望的結果,沒有明顯的安全或耐受性問題。AD04也被認爲有潛力治療其他成癮性障礙,如阿片類藥物使用障礙、博彩和肥胖症。可在公司的網站上獲取更多信息。
前瞻性聲明
本文包含某些根據美國聯邦證券法律規定的"向前看語句"。這些聲明基於各種事實和得出的重要假設,並受到已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致實際結果、業績或成就與任何未來結果、業績或成就有實質性不同。以"相信"、"期望"、"預計"、"計劃"和類似表達式或未來或條件動詞(例如"將"、"應該"、"將會"、"可能"和"能夠")開頭、結尾或包括的語句,如"瀏覽"、"跟隨"或其他類似語言。向前看語句通常是向前看性質,並非歷史事實,雖然並非所有向前看語句都包括前述內容。向前看語句包括有關AD04藥代動力學研究要花費6個月左右完成的聲明,這項研究將產生數據,有助於公司優化AD04關鍵第三階段臨床試驗所需的研究設計元素,包括評估在AUD患者中最大化AD04療效和安全性的最佳劑量方案,該研究將增加公司即將進行的AD04第三階段試驗的成功機會,該研究還將提供必要的數據,以支持AD04在FDA 505(b)(2)監管途徑下的批准申請,在2024年第四季度與FDA進行磋商,討論該藥代動力學研究的結果並獲得反饋,以進一步推進AD04向監管批准的進展,該研究將連續進行兩個隊列,預計將於2024年第四季度初完成,招募多達30名健康成年志願者,該研究將提供有關AD04藥代動力學特性的有價值信息,包括其吸收、分佈、代謝和排泄以及食物對其生物利用度的影響,預計於2024年第四季度初公佈首要結果以及AD04有望治療其他成癮障礙,如阿片類物質使用障礙、博彩和肥胖病的潛力。這些風險不應被視爲詳盡無遺,並應與我們在2023年12月31日年度報告10-K、後續季度報告10-Q和提交給證券交易委員會的當前報告8-K中包括的其他謹慎聲明一起閱讀。任何向前看語句僅於其最初發表的日期發表。我們無義務公開更新或修訂任何向前看語句,除非法律要求。
聯繫方式:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
電話:212-671-1020
電子郵件:adil@crescendo-ir.com