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."
周四，Adial Pharmaceuticals Inc（纳斯达克：adil）宣布其第三阶段ONWARDS研究的先前披露结果已在《欧洲内科学杂志》的同行评审文章中发表。文章标题为“低剂量依托咪酯：一种候选前瞻性精准治疗酒精使用障碍内源性表现。”该研究发现，公司的主要资产AD04（低剂量依托咪酯）与安慰剂组相比，在重度饮酒患者和特定基因型变异者中，每月重度饮酒日的百分比存在显著差异。独家报道：Adial Pharmaceuticals开始对AD04进行药代动力学研究以治疗酒精使用障碍。
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.
关键发现包括：AD04显著降低了在伴侣诊断检测（CDx）确定的酒精使用障碍患者和特定基因型患者中治疗6个月后的重度饮酒日百分比。
Related: EXCLUSIVE: Adial Pharmaceuticals Starts Patient Dosing In Pharmacokinetics Study Of AD04 For Alcohol Use Disorder.
相关新闻: 吉利德的 Trodelvy 在普通膀胱癌最常见类型的后期研究中未能达到主要目标。补充分析表明，AD04治疗的患者出现最少的不良事件，与安慰剂治疗相当，服药依从性高，退出率很低。
Key findings include:
将AD04与心理社会干预相结合，可能有利于改变酒精使用障碍疾病的观念，增加许多原本没有考虑过该治疗的人的需求。
- 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.
- 该研究探讨了内源性表现在预测AD04治疗酒精使用障碍的有效性方面的作用，并发现影响血清素转运体和血清素AB受体复合物的特定基因型可以预测AD04减少酒精使用障碍患者重度饮酒日数量的能力。
- 特别是，数据显示，具有特定基因背景并符合定义为“重度饮酒者”标准的个体，在治疗6个月后，每月重度饮酒日的百分比有所降低。
- 作者进一步指出，在已有的酒精文献研究中，没有一项有效的药物会表现出与安慰剂类似的不良事件的风险。
- ADIL股票周二收于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.
研究分析了内源性表型的作用，预测AD04对治疗AUD的疗效，并发现影响5-羟色胺转运体和5-羟色胺-AB受体复合物的特定基因型可以预测AD04减少AUD患者饮酒次数的能力。
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.
特别是，数据显示，具有特定遗传背景并符合“重度饮酒者”的标准的个体，在6个月治疗后，重度饮酒日的月百分比有所减少。
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.
作者进一步指出，在酒精文献中没有一项现有研究表明，有效的药物具有类似于安慰剂的不良事件概况。
Price Action: ADIL shares closed at $1.27 on Tuesday.
股票行情：ADIL股票周二收盘价为1.27美元。