Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder
Adial Pharmaceuticals Announces Peer-Reviewed Publication Highlighting Promising Safety Data and High Patient Compliance in a Clinical Trial of AD04 as a Potential Treatment for Alcohol Use Disorder
Findings underscore the liver safety of AD04 as compared to placebo in the prior Phase 3 clinical trial
研究結果突顯了先前的3期臨床試驗中與安慰劑相比，AD04的肝臟安全性
GLEN ALLEN, Va., April 10, 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 a peer-reviewed article highlighting the promising clinical results, strong safety profile and high compliance among patients administered AD04 (low-dose ondansetron), the Company's lead investigational new drug product being developed for the treatment of Alcohol Use Disorder (AUD). The publication also reported the results of a new study analyzing the liver safety profile of AD04 compared with placebo in subjects with AUD in the Company's prior Phase 3 clinical trial.
弗吉尼亞州格倫艾倫，2024年4月10日（GLOBE NEWSWIRE）——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Adial Pharmicals, Inc.（納斯達克股票代碼：ADIL）（“Adil” 或 “公司”）宣佈發表了一篇經過同行評審的文章，重點介紹了服用AD04（低）患者的臨床結果、良好的安全性以及高依從性 dose ondansetron），該公司正在開發的用於治療酒精使用的主要研究性新藥產品失調（澳元）。該出版物還報告了一項新研究的結果，該研究分析了該公司先前的3期臨床試驗中AD04與安慰劑對比的肝臟安全性。
The published study provides a comprehensive analysis of the liver safety profile of AD04 compared to a placebo in individuals with AUD and a specific 5-marker genetic profile. AUD, characterized by compulsive alcohol consumption and loss of control over intake, poses significant health risks and is a major contributor to alcohol-associated liver disease (ALD), a leading cause of liver transplantation and global mortality.
已發表的研究全面分析了AUD患者和特定的5標記遺傳特徵患者中AD04與安慰劑相比的肝臟安全概況。澳元以強迫性飲酒和失去攝入控制爲特徵，構成嚴重的健康風險，是酒精相關性肝病（ALD）的主要病因，酒精相關肝病是肝移植和全球死亡的主要原因。
According to the publication, low-dose AD04 did not significantly change biochemical markers of liver injury, such as ALT, AST, and Serum Bilirubin. Additionally, while patients with AUD displayed elevated GGT levels, typically associated with increased alcohol consumption, this parameter remained unaffected by low-dose AD04. Additionally, no significant adverse effects were observed due to oral low-dose AD04 treatment. The publication also highlighted that low-dose AD04 demonstrated an outstanding safety and tolerability profile compared to placebo, featuring a low occurrence of adverse events (AEs), 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.
根據該出版物，低劑量AD04沒有顯著改變肝損傷的生化標誌物，例如ALT、AST和血清膽紅素。此外，雖然AUD患者表現出GGT水平升高，通常與飲酒量增加有關，但該參數仍未受到低劑量AD04的影響。此外，口服低劑量AD04治療未觀察到明顯的不良反應。該出版物還強調，與安慰劑相比，低劑量AD04表現出優異的安全性和耐受性，不良事件（AE）發生率低，藥物依從性高，輟學率最低。作者進一步指出，酒精文獻中沒有一項研究表明有效的藥物表現出與安慰劑相似的AE特徵。
The manuscript entitled, "Safety and compliance of long-term low-dose ondansetron in alcohol use disorder treatment," was published in the European Journal of Internal Medicine. The publication is available via Open Access at:
這份題爲 “長期低劑量恩丹西酮在酒精使用障礙治療中的安全性和合規性” 的手稿發表在《歐洲內科醫學雜誌》上。該出版物可通過開放獲取獲取，網址爲：
Cary Claiborne, CEO of Adial, commented, "Current pharmacological treatments for AUD are limited by low efficacy, poor adherence and adverse effects. This peer-reviewed publication emphasizes the safety and potential of AD04 in addressing the critical needs of individuals suffering from AUD and ALD. With this significant milestone, we are one step closer to providing a precision treatment option that could make a profound impact on the lives of millions worldwide."
Adial首席執行官Cary Claiborne評論說：“目前的澳元藥物治療因療效低、依從性差和不良反應而受到限制。這份經過同行評審的出版物強調了AD04在滿足澳元和ALD患者的關鍵需求方面的安全性和潛力。有了這個重要的里程碑，我們離提供可能對全球數百萬人的生活產生深遠影響的精準治療選擇又近了一步。”
"This study report further supports prior data showing that AD04 treatment does not pose significant health risks in patients with AUD. AD04 was well tolerated, and no treatment related serious adverse events were observed. AD04 treatment was not associated with significant changes in liver biochemical parameters, cardiac events, or general well-being. Most importantly, the publication highlighted the potential of AD04 for the treatment for AUD among patients with a specified genetic background. Ultimately, we believe AD04 could pave the way for precision treatments tailored to individuals with AUD, offering a novel strategy to not only manage alcohol consumption but also mitigate liver damage in affected populations," concluded Claiborne.
“這份研究報告進一步支持先前的數據，這些數據表明，AD04治療不會對澳元患者構成重大健康風險。AD04耐受性良好，未觀察到與治療相關的嚴重不良事件。AD04 治療與肝臟生化參數、心臟事件或總體健康狀況的顯著變化無關。最重要的是，該出版物強調了AD04在具有特定遺傳背景的患者中治療AUD的潛力。最終，我們相信AD04可以爲針對澳元患者量身定製的精準治療鋪平道路，提供一種新策略，不僅可以管理酒精消費，還可以減輕受影響人群的肝損傷，” 克萊伯恩總結道。
譯文內容由第三人軟體翻譯。