独家：Adial Pharmaceuticals公布了AD04治疗酒精使用障碍的药代动力学研究结果-动脉网

EXCLUSIVE: Adial Pharmaceuticals Reveals Topline Results From Pharmacokinetics Study Of AD04 For Alcohol Use Disorder

benzinga 等信源发布 2024-11-14 08:00

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Thursday, Adial Pharmaceuticals Inc ADIL said it has completed a pharmacokinetics (PK) study of AD04 for Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than ten drinks/drinking day).

周四，Adial Pharmaceuticals Inc ADIL表示，它已经完成了AD04在重度饮酒患者（定义为每天饮酒少于十杯）中的药代动力学（PK）研究。

This data will help the company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04.

这些数据将有助于该公司优化即将进行的AD04 3期临床试验所需的研究设计元素。

Completing the study also satisfied an FDA requirement for the upcoming Phase 3 trials of AD04.

完成这项研究也满足了FDA对即将进行的AD04第3阶段试验的要求。

Also Read: EXCLUSIVE: Adial Pharmaceuticals Advances Regulatory Strategy For Companion Diagnostic Genetic Test For Its Lead Program For Alcohol Use Disorder

另读：独家：Adial Pharmaceuticals为其酒精使用障碍的主要项目推进了伴随诊断基因检测的监管策略

The single-center, relative bioavailability, open-label study enrolled 30 healthy adult volunteers in two cohorts.

这项单中心相对生物利用度开放标签研究在两个队列中招募了30名健康成年志愿者。

Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg.

队列1（n=6）是一项随机，开放标签，2序列，2期交叉研究，用于评估昂丹司琼从AD04 0.33和0.99mg的PK变异性。

Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet..

队列2（n=24）是一项随机，开放标签，6序列，4期交叉研究，旨在评估AD04 0.33mg片剂与市售昂丹司琼4mg片剂的相对生物利用度，昂丹司琼PK在AD04 0.33和0.99mg之间的剂量比例，以及食物对作为AD04 0.33mg片剂给药的昂丹司琼生物利用度的影响。。

The results of this study showed that, due to the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3–fold AD04 dose range; and AD04 can be taken in fed or fasted states. .

这项研究的结果表明，由于剂量较低，AD04 0.33mg的昂丹司琼PK暴露量低于市售参考标准昂丹司琼4mg片剂；在3倍的AD04剂量范围内，昂丹司琼的药代动力学暴露与剂量成比例增加；。。

Its completion is in accordance with previous guidance provided by the FDA. This relatively short and low-cost study was key to the strategy to advance ongoing partnership discussions.

。这项相对较短且成本较低的研究是推动正在进行的伙伴关系讨论的战略的关键。

Additionally, the study will provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with the FDA.

此外，该研究将提供必要的数据，以支持FDA根据505（b）（2）监管途径批准AD04的申请。

The company plans to engage with the FDA during the fourth quarter of 2024 with the results of this pharmacokinetics study and obtain feedback that will assist with the AD04 Phase 3 study program.

该公司计划在2024年第四季度与FDA合作，获得这项药代动力学研究的结果，并获得有助于AD04第三阶段研究计划的反馈。

Price Action: ADIL stock is down 0.01% at $0.99 during the premarket session at last check Thursday.

价格走势：在周四最后一次检查的上市前交易中，ADIL股价下跌0.01%，至0.99美元。