Completion enables the End-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and is expected to facilitate ongoing partnership discussions

Adial’s formulation exhibited predictable bioavailability relative to the reference standard; near-micro doses exhibited dose proportionality in pharmacokinetic exposure, and no food effect

Safety and tolerability consistent with ondansetron’s extensive human use experience

GLEN ALLEN, Va., Jan.  29, 2025  (GLOBE NEWSWIRE) -- 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 the completion of a pharmacokinetics (PK) study of AD04, and has made a regulatory submission of the results to the FDA. AD04 is the Company's investigational drug candidate, a selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of Alcohol Use Disorder (AUD) in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and conform with the FDA’s bridging requirements for a 505(b)(2) registration pathway.

The purpose of the study, AD04-103, was to evaluate the PK, bioavailability, and food effect of AD04 near-micro doses relative to marketed ondansetron in healthy volunteers (HVs). The study was conducted in two phases and enrolled a total of 30 HVs in two cohorts.

Cohort 1 (n=6): A randomized, open-label, two-sequence, two-period crossover study evaluating the PK variability of ondansetron in AD04 0.33 mg and 0.99 mg doses.Cohort 2 (n=24): A randomized, open-label, six-sequence, four-period crossover study evaluating the relative bioavailability of AD04 0.33 mg tablets compared to marketed ondansetron 4 mg tablets, the dose proportionality of ondansetron PK between AD04 0.33 mg and 0.99 mg doses, and the food effect on the bioavailability of ondansetron administered as AD04 0.33 mg tablets.

The results of the study confirmed that ondansetron pharmacokinetic exposure increased proportionally across a three–fold AD04 dose range, between AD04 0.33 mg tablets and the marketed ondansetron 4 mg tablets. Additionally, the study demonstrated that AD04 can be taken with or without food.

Cary Claiborne, President and Chief Executive Officer of Adial commented, “Successful completion of this bridging study supports our plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway. We have engaged with the FDA on the results of this PK bridging study and will incorporate their feedback as we prepare for our End-of-Phase 2 meeting, targeted to take place in the first half of this year. We are excited to achieve this important milestone on the path toward regulatory approval.”

About AD04
AD04 (0.33 mg 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. Adial's prior clinical studies have indicated that patients with mutations in the 5HT3 receptor may 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.

Adial has already developed a companion diagnostic test (CDx) to select patients with the specific genomic biomarker that may benefit from AD04. It was successfully used in a large scale randomized controlled trial (RCT), the ONWARD study, and will be advanced in future clinical studies, to support FDA approval and commercial availability 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 selective serotonin-3 receptor antagonist. AD04 is being developed for the treatment of Alcohol Use Disorder (AUD) in patients with a 5-HT3 genomic biomarker. AD04 was recently investigated in a large scale RCT, the ONWARD™ study for the potential treatment of AUD in subjects with certain target genotypes. 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 completion of the pharmacokinetics study of AD04 for the Treatment of Alcohol Use Disorder enabling the end-of-Phase 2 (EOP2) interaction with the FDA on the design of the Phase 3 program and facilitating ongoing partnership discussions, study results supporting the near micro-dosing regimen planned for use in the upcoming registration trials for AD04, successful completion of this bridging study supporting the Company’s plans to pursue FDA approval of AD04 under the 505(b)(2) regulatory pathway, incorporating FDA feedback on the results of the PK bridging study, preparing for an End-of-Phase 2 meeting in the first half of this year, advancing the Company’s companion diagnostic test (CDx) in future clinical studies to support FDA approval, commercial availability at the time of AD04's launch, 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.

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