EXCLUSIVE: Adial Pharmaceuticals Announces Publication In Journal Supporting the Potential Efficacy Of AD04 For Alcohol Use Disorder
EXCLUSIVE: Adial Pharmaceuticals Announces Publication In Journal Supporting the Potential Efficacy Of AD04 For Alcohol Use Disorder
On Thursday, Adial Pharmaceuticals Inc (NASDAQ:ADIL) 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."
週四，Adial Pharmicals Inc（納斯達克股票代碼：ADIL）在一篇經過同行評審的文章中宣佈了先前披露的3期後續研究結果 歐洲內科雜誌 標題爲 “低劑量恩丹西酮：治療酒精濫用內分型的候選前瞻性精準藥物。”
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 and specific genotypic variants.
該出版物的調查結果顯示，該公司的主要資產AD04（低劑量昂丹西酮）與重度飲酒患者和特定基因型變異的安慰劑組之間的每月大量飲酒天數百分比存在顯著差異。
Related: EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder.
相關： 獨家：Adial Pharmaceuticals開始在AD04酒精使用障礙的藥代動力學研究中給患者服藥。
Key findings include:
主要發現包括：
- AD04 significantly decreased the monthly percentage of heavy drinking days after six months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a companion diagnostic (CDx).
- This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex.
- Additional analysis revealed that patients treated with AD04 experienced minimal adverse events, which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate.
- Combining AD04 with psychosocial intervention may change favorably how alcohol use disorder disease is perceived and increase the demand for treatment to many who have not otherwise considered it.
- 根據伴隨診斷（CDx），AD04顯著降低了患有酒精使用障礙和特定遺傳特徵的重度飲酒者在接受六個月治療後的每月大量飲酒天數百分比。
- 這種基因型特徵存在於血清素轉運蛋白和血清素-AB 受體複合物中。
- 其他分析顯示，接受AD04治療的患者出現的不良事件微乎其微，與安慰劑治療相當，藥物依從性高，輟學率最低。
- 將AD04與心理社會干預相結合可能會有利地改變人們對酒精使用障礙疾病的看法，並增加許多原本沒有考慮過酒精使用障礙的人的治療需求。
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.
該研究考察了內表型在預測AD04治療澳元療效中的作用，發現影響血清素轉運蛋白和血清素-AB受體複合物的特定基因型可以預測AD04減少澳元患者大量飲酒天數的能力。
In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as "heavy drinkers" saw a reduction in the monthly percentage of heavy drinking days after six months of treatment.
特別是，數據顯示，具有特定遺傳背景並符合 “大量飲酒者” 標準的人在接受六個月的治療後，每月大量飲酒天數的百分比有所下降。
The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar adverse events profile to a placebo.
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不良事件特徵。
Price Action: ADIL shares closed at $1.27 on Tuesday.
價格走勢：ADIL股價週二收於1.27美元。
譯文內容由第三人軟體翻譯。