独家：Adial制药公司针对酒精使用障碍的主打候选药物迈向第 3阶段试验-动脉网

EXCLUSIVE: Adial Pharmaceuticals Lead Candidate For Alcohol Use Disorder Advances Toward Phase 3 Trial

benzinga 等信源发布 2025-06-11 07:30

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Adial Pharmaceuticals, Inc.

阿迪亚尔制药公司

ADIL

公平的

on Wednesday announced progress in the design and planning of its upcoming Phase 3 trial evaluating AD04, the company's lead investigational genetically targeted, serotonin-3 receptor antagonist, a

周三宣布了其即将进行的第三阶段试验的设计和规划进展，该试验评估了公司主要研究的基因靶向、血清素-3受体拮抗剂AD04。

therapeutic agent for Alcohol Use

酒精使用治疗剂

Disorder (AUD) in heavy drinking patients (defined as < 8 drinks/day).

重度饮酒患者（定义为每天饮酒小于8杯）的酒精使用障碍（AUD）。

As part of its Phase 3 trial preparation, Adial engaged

作为其第三阶段试验准备的一部分，Adial进行了

Cytel Inc

赛泰尔公司

。

, a provider of data science and advanced statistical methodologies for clinical trials, to provide expert support on trial design and data interrogation.

，一家为临床试验提供数据科学和高级统计方法的供应商，提供关于试验设计和数据审查的专家支持。

Cytel's contributions have helped inform key design elements of Adial's upcoming trial, which aims to maximize efficiency, cost-effectiveness, and the likelihood of success.

Cytel的贡献帮助告知了Adial即将进行的试验的关键设计元素，该试验旨在最大化效率、成本效益和成功可能性。

Also Read:

另请阅读：

EXCLUSIVE: After FDA Response, Adial Starts Manufacturing Clinical Supplies For Upcoming Phase 3 Program Of Lead Candidate For Alcohol Use Disorder

独家：在FDA回复后，Adial开始为即将进行的酒精使用障碍主导候选药物的第三阶段计划生产临床供应。

In part, Cytel's efforts identified specific genetic subpopulations potentially more responsive to AD04, enabling a refined Phase 3 strategy that aligns with clinical and regulatory expectations.

部分而言，Cytel的努力确定了可能对AD04更敏感的特定基因亚群，从而制定了符合临床和监管期望的精细化III期策略。

Highlights:

亮点：

Post-hoc historical clinical trial data analyses identified genotype-defined patient subgroups likely to benefit most from AD04. This supports Adial's precision medicine approach in the upcoming Phase 3 trial, which targets higher efficacy and commercial differentiation.

事后对历史临床试验数据的分析确定了最有可能从AD04中获益的基因型定义的患者亚组。这支持了Adial在即将到来的第三阶段试验中采用的精准医疗方法，该方法旨在实现更高的疗效和商业差异化。

Adial partnered with Cytel to apply advanced statistical analytics and simulation modeling to optimize the trial design, enable adaptive enrichment, and align with regulatory expectations.

Adial与Cytel合作，应用高级统计分析和模拟建模来优化试验设计、实现适应性富集，并符合监管期望。

The Phase 3 trial is expected to begin in late 2025, with the potential for interim analysis-driven readouts supporting a streamlined path to potential regulatory submission.

三期试验预计将于2025年底开始，通过中期分析驱动的数据读出，有望支持一条简化的路径以实现潜在的监管提交。

Why It Matters

重要性所在

Adial said in a statement on Wednesday that AD04 represents a first-in-class opportunity in the multi-billion-dollar global AUD market and that its refined clinical strategy will accelerate value realization.

Adial公司在周三的一份声明中表示，AD04代表了全球数十亿美元的AUD市场中的首创新药机会，并且其优化的临床策略将加速价值实现。

In May, the U.S. Food and Drug Administration (FDA) granted the company's request for an End of Phase 2 meeting to discuss its proposed clinical development plan and seek the U.S. Food and Drug Administration (FDA) guidance on the

今年 5 月，美国食品药品监督管理局 (FDA) 接受了该公司的请求，召开第 2 阶段末会议，讨论其拟议的临床开发计划，并寻求美国食品药品监督管理局 (FDA) 的指导。

Phase 3 trial for AD04

AD04的第三阶段试验

. The meeting will take place

会议将举行。

on July 25, 2025

2025年7月25日

。

The United States Patent and Trademark Office (USPTO) issued patent number 12,274,692

美国专利商标局（USPTO）发布了专利号12,274,692

to AD04 in May

五月到AD04