ADILW Adial Pharmaceuticals Inc

 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 < 10 drinks/drinking day). The study is expected to take 6 months to complete and is intended to produce data which will help the Company to optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study will also satisfy a requirement of the FDA guidance for the upcoming Phase 3 clinical trial of AD04.

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.

Forward-Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the pharmacokinetics study of AD04 taking 6 months to complete, the study producing data which will help the Company to optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04, including evaluating the optimal dosing regimen to maximize the efficacy and safety of AD04 in patients with AUD, the study enhancing the likelihood of success in the Company’s upcoming Phase 3 trial, the study also providing data necessary to support an application for approval of AD04 under a 505(b)(2) regulatory pathway with FDA, engaging with the FDA in Q4 2024 to discuss the results of the study and obtain feedback to refine the Phase 3 study design, the meeting helping establish the final protocol and ensuring that it aligns with FDA expectations, further advancing AD04 towards regulatory approval, the study involving two cohorts conducted consecutively and being completed in early Q4 2024, enrolling up to 30 healthy adult volunteers, the study providing valuable information on the pharmacokinetic properties of AD04, including its absorption, distribution, metabolism, and excretion, as well as the effect of food on its bioavailability, reporting topline results in early Q4 2024 and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:Crescendo Communications, LLC                        David Waldman / Alexandra Schilt                        Tel: 212-671-1020                                Email: adil@crescendo-ir.com