AD04 reduced heavy drinking days among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as identified by a companion diagnostic test (CDx)
GLEN ALLEN, Va., June 20, 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 the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, "Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes." The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company's lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants.
Key findings include:
- AD04 significantly decreased the monthly percentage of heavy drinking days after 6 months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a CDx
- This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex
- AD04′s adverse events (AEs) match those of the placebo
- Combining AD04 with psychosocial intervention may change favorably how AUD disease is perceived and increase the demand for treatment to many who not have otherwise considered it
"The findings highlighted in the publication underscore the promise of AD04, with incorporation of a CDx, as an important advancement in the field of precision medicine. This approach is critical as AUD can be caused by a variety of gene-environment interactions and does not manifest uniformly across all patients," said Cary Claiborne, CEO of Adial. "We believe patients struggling with AUD stand to gain greater benefit from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one size fits all approach. Recognizing the benefits of AD04 within this genetically and behaviorally defined patient population will allow Adial to continue developing a 21st-century-based approach to the treatment of this devastating disorder. AD04 offers a novel strategy to manage AUD by reducing the potential harm of AUD, while lowering the perceived stigma of personal failure associated with the disorder."
The study examined the role of endophenotypes in predicting AD04's efficacy for the treatment of AUD and found that specific genotypes affecting the serotonin transporter and serotonin-AB receptor complex are predictive of AD04's ability to reduce the number of heavy drinking days among patients with AUD. In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as "heavy drinkers" (avg. <10 drinks per drinking day) saw a reduction in the monthly percentage of heavy drinking days after 6 months of treatment. Additional analysis revealed that patients treated with AD04 experienced minimal AEs which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.
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 potential use of AD04 as a precision medicine for the treatment of AUD, combining AD04 with psychosocial intervention changing favorably how AUD disease is perceived and increasing the demand for treatment to many who not have otherwise considered it, patients struggling with AUD standing to gain greater benefit from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one size fits all approach, recognizing the benefits of AD04 within this genetically and behaviorally defined patient population allowing Adial to continue developing a 21st-century-based approach to the treatment of this devastating disorder, AD04 offering a novel strategy to manage AUD by reducing the potential harm of AUD while lowering the perceived stigma of personal failure associated with the disorder 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
AD04通過CDx檢測,可降低酒精濫用者飲酒重度天數。
弗吉尼亞州格倫艾倫,2024年6月20日(環球新聞社) - 一項發表在《歐洲內科雜誌》上的同行評審文章中公佈了Adial製藥公司(納斯達克:ADIL)(“Adial”或“公司”)先前披露的第3期ONWARD研究結果。文章題爲“低劑量丹生西隆:治療酒精使用障礙內部表型的候選前瞻性精準醫學”。公佈的結果顯示,相對於酗酒患者中安慰劑組,該公司的主導優勢 AD04(低劑量丹生西隆),針對伴隨特定遺傳型的酗酒患者,在每月飲酒重度天數方面有顯着差異。《歐洲內科雜誌》發表了題爲“低劑量丹生西隆:治療酒精使用障礙內部表型的候選前瞻性精準醫學”的文章,介紹了AD04明確的療法。研究結果發現,通過CDx檢測可降低AD04治療酒精使用障礙的飲酒重度天數,針對具有特定基因型變異的酗酒患者和特定遺傳和行爲家族,AD04有重要作用。
將AD04與心理社會干預相結合,可能有利於改變酒精使用障礙疾病的觀念,增加許多原本沒有考慮過該治療的人的需求。
- AD04通過CDx檢測,可降低酒精濫用者飲酒重度天數。
- 該遺傳型在血清素轉運體和血清素-AB受體複合物中
- AD04的不良事件(AEs)與安慰劑相同
- 將AD04與心理社會干預相結合,可以有益地改變患有酒精使用障礙的疾病認知,並提高許多本來不考慮治療的人的治療需求。
Adial首席執行官Cary Claiborne認爲:“發現AD04結合CDx作爲精準醫學領域的重要進展。這一方法非常關鍵,因爲酒精使用障礙可能是由多種基因環境互動引起的,並不在所有患者中表現一致。我們相信相對於‘一劑適用於所有人’的方法,患有酒精使用障礙的患者更適合使用精準治療來減少飲酒量,如AD04。認識到AD04在此遺傳和行爲定義的患者人群中的益處,將使Adial繼續開發21世紀的治療方法,減少這種破壞性劑量的混聲效果。AD04提供了管理酒精使用障礙的新策略,可以減少酒精使用障礙的潛在危害,同時降低與該障礙相關的個人失敗感。‘
該研究探討了內部表型在預測AD04對治療酒精使用障礙的有效性方面的作用,並發現影響血清素轉運體和血清素-AB受體複合物的特定基因型預測AD04減少患者飲酒重度天數的能力。特別是,該數據顯示,在治療6個月後,特定基因背景和符合“重度飲酒者”(每天平均<10杯)定義條件的患者,每月飲酒重度天數有所降低。進一步分析發現,接受AD04治療的患者經歷了最小的關心併發症,這些併發症與接受安慰劑的治療比較,藥物合規性高,退出的比例也很小。作者進一步指出,酒精文獻中不存在類似的研究,其中有效的藥物顯示類似的AE配置文件的安慰劑。
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是一家專注於開發治療成癮和相關疾病的臨床階段生物製藥公司。該公司的主要新藥研發產品AD04是一種基因靶向的5-HT3受體拮抗劑,用於治療酒精使用障礙(AUD)患者的重度飲酒,並最近在公司的ONWARD關鍵性3期臨床試驗中研究作爲AUD潛在治療方法,用於特定靶向基因型的患者並通過公司的伴隨診斷基因檢測鑑定。ONWARD在重度飲酒患者中減少飲酒方面顯示出有希望的結果,沒有明顯的安全或耐受性問題。AD04也被認爲具有治療其他成癮性疾病的潛力,如阿片類物質使用障礙、博彩和肥胖症。更多信息請瀏覽網站。
前瞻性聲明
本文包含特定的“前瞻性聲明”,其意義在於美國聯邦證券法。這些聲明是基於各種事實和推斷進行的,涉及許多重要的假設,並受到已知和未知的風險、不確定性和其他因素的影響,這些因素可能導致任何未來的結果、表現或成就與該等前瞻性聲明所反映的結果、表現或成就有實質不同。以“相信”、“預計”、“期望”、“計劃”、“估計”、“計劃”和類似表達或未來或有條件的動詞,如“將”、“應”、“會”、“可能”和“可能”等爲前綴、後綴或以其他方式包含這樣的前瞻性思維的聲明通常是具有前瞻性的性質,而不是歷史事實。其中包括關於AD04作爲治療酒精使用障礙的精準藥物的潛力,將AD04與心理社會干預結合起來,有利於改變酒精使用障礙疾病的認知,並提高許多本來不考慮治療的人的治療需求,患有酒精使用障礙的患者從精準治療中受益更多,以減少酒精消費,例如AD04,而不是一種尺碼適合所有的方法,以認識AD04在這個通過遺傳學和行爲定義的患者群體中的好處,使Adial繼續開發治療這種破壞性障礙的21世紀基礎方法,AD04通過減少酒精使用障礙的潛在危害,降低與該障礙相關的個人失敗感,以及AD04治療其他成癮性障礙,例如阿片類藥物使用障礙、賭博和肥胖症的潛力。這裏包含的任何前瞻性聲明都反映了我們當前的觀點,並涉及一定的風險和不確定性,包括我們追求監管戰略的能力,我們能夠推進進行中的合作伙伴討論的能力,我們能夠獲得產品候選藥物商業化的監管批准,或遵守不斷變化的監管要求的能力,我們能夠開發戰略性合作伙伴機會並維持合作關係,我們能夠獲得或維持資本或資助來資助我們的研究和開發活動,我們能夠按時完成臨床試驗並達到預期的結果和收益,與我們特定指示的產品候選藥物推廣或商業化相關的監管限制,我們的產品候選藥物在市場上的接受度和成功的開發、營銷或銷售我們的產品,我們能夠保持我們的許可協議,我們專利財產維護和增長的持續維護以及我們能夠保留我們的關鍵員工或保持我們的Nasdaq上市。這些風險不應被解釋爲詳盡無遺,應與我們提交給證券交易委員會的關於2013年12月31日年度報告、隨後提交的季度報告和在當前提交的有關8-K表格中包含的其他警告性聲明一起閱讀。任何前瞻性聲明僅於其最初發表的日期,除非法律規定,否則我們不承擔公開更新或修正任何前瞻性聲明的義務。
聯繫方式:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
電話:212-671-1020
電子郵件:adil@crescendo-ir.com