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 Pharmaceuticals Inc（納斯達克：adil）宣佈其第三階段ONWARDS研究的先前披露結果已在《歐洲內科學雜誌》的同行評審文章中發表。文章標題爲“低劑量依託咪酯：一種候選前瞻性精準治療酒精使用障礙內源性表現。”該研究發現，公司的主要資產AD04（低劑量依託咪酯）與安慰劑組相比，在重度飲酒患者和特定基因型變異者中，每月重度飲酒日的百分比存在顯著差異。獨家報道：Adial Pharmaceuticals開始對AD04進行藥代動力學研究以治療酒精使用障礙。
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.
關鍵發現包括：AD04顯著降低了在伴侶診斷檢測（CDx）確定的酒精使用障礙患者和特定基因型患者中治療6個月後的重度飲酒日百分比。
Related: EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder.
相關新聞: 吉利德的 Trodelvy 在普通膀胱癌最常見類型的後期研究中未能達到主要目標。補充分析表明，AD04治療的患者出現最少的不良事件，與安慰劑治療相當，服藥依從性高，退出率很低。
Key findings include:
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 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.
- 該研究探討了內源性表現在預測AD04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可以預測AD04減少酒精使用障礙患者重度飲酒日數量的能力。
- 特別是，數據顯示，具有特定基因背景並符合定義爲“重度飲酒者”標準的個體，在治療6個月後，每月重度飲酒日的百分比有所降低。
- 作者進一步指出，在已有的酒精文獻研究中，沒有一項有效的藥物會表現出與安慰劑類似的不良事件的風險。
- ADIL股票週二收於1.27美元。
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.
研究分析了內源性表型的作用，預測AD04對治療AUD的療效，並發現影響5-羥色胺轉運體和5-羥色胺-AB受體複合物的特定基因型可以預測AD04減少AUD患者飲酒次數的能力。
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“重度飲酒者”的標準的個體，在6個月治療後，重度飲酒日的月百分比有所減少。
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，在酒精文獻中沒有一項現有研究表明，有效的藥物具有類似於安慰劑的不良事件概況。
Price Action: ADIL shares closed at $1.27 on Tuesday.
股票行情：ADIL股票週二收盤價爲1.27美元。
譯文內容由第三人軟體翻譯。