Adial Pharmaceuticals Achieves Important Milestone of First Patient Dosed in Pharmacokinetics Study of AD04 for the Treatment of Alcohol Use Disorder

2024-06-07

研发

临床3期临床结果

Study intended to optimize design elements needed for the upcoming US Pivotal Phase 3 studies

and support ongoing partnership discussions

Topline results expected in early Q4 2024

June 05, 2024 -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, announced that the first patient has been dosed in a pharmacokinetics study of AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as Cary Claiborne, President and Chief Executive Officer of Adial commented, “Dosing our first patient is an important milestone, marking the beginning of clinical activity in this previously planned and pre-budgeted study. Our goal is to obtain data we need to design a more precise and informed Phase 3 trial protocol, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD. Completion of this study is in accord with previous guidance provided by the FDA and is intended to enhance the likelihood of success in our upcoming Phase 3 trial. This relatively short and low-cost study is also a key element of our strategy to advance ongoing partnership discussions. The study will also provide data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA. Looking ahead, we plan to engage with the FDA in Q4 2024 to discuss the results of this pharmacokinetics study and obtain feedback to refine the Phase 3 study design. This meeting will help establish the final protocol and ensure that it aligns with FDA expectations, further advancing AD04 towards regulatory approval.”

The pharmacokinetics study will involve two cohorts conducted consecutively and is expected to be completed in early Q4 2024. The single-center, relative bioavailability, open-label study will enroll up to 30 healthy adult volunteers and compare the pharmacokinetic profile of AD04 when administered as an oral dose taken twice daily of 0.33 mg with or without food against a reference standard product. This study will provide valuable information on the pharmacokinetic properties of AD04. The company expects to report topline results in early Q4 2024.

About AD04

AD04 (0.33mg ondansetron taken orally twice daily) acts upon the 5HT3 pathway and is thought to reduce alcohol craving. This mode of action is distinct from, but complimentary to, the currently approved therapies for AUD. Post-hoc analyses of Adial’s prior clinical studies have indicated that patients with mutations in the 5HT3 receptor experience substantial and clinically meaningful reductions in alcohol consumption. The specific mutations that appear to respond to AD04 are single nucleotide polymorphisms (SNPs) on rs1150226-AG (“AG”) or rs1176713-GG (“GG”) genotypes in the gene that encodes the 5-HT3A receptor subunit. These genes are thought to affect the binding of AD04 to the 5HT3 receptor and its function. Furthermore, in both previous clinical trials, AD04 had similar adverse events to placebo, demonstrating that it is extremely safe and tolerable.

Adial has already developed a companion diagnostic test (CDx) to identify the specific genotypes that benefit from AD04. This test was used in its Phase 3 ONWARD study, will be used in future clinical studies, and will be commercially available at the time of AD04's launch.

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.

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