Adial Pharmaceuticals Announces Publication in Leading Peer Reviewed Journal Supporting Potential Effectiveness of AD04 as a Precision Medicine for the Treatment of Alcohol Use Disorder

AD04 Reduced Binge Drinking Days in Heavy Drinkers With Alcohol Use Disorder and a Specific Genetic Profile, Identified by a Companion Diagnostic Test (CDx)

GLEN ALLEN, Va., June 20, 2024 (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 substance abuse and related disorders, announced the release of previously disclosed results from its phase study 3 ONWARD in a peer-reviewed journal. article in the European Journal of Internal Medicine titled “Low-dose ondansetron: a prospective precision medicine candidate to treat alcohol use disorder endophenotypes.” The results of the publication showed a significant difference in the monthly percentage of binge drinking days between the company’s lead asset, AD04 (low-dose ondansetron), and the placebo group among patients who drink heavily and suffer from alcohol use disorders (AUD) and specific genotypic variants.

Key findings include:

• AD04 significantly reduced the monthly percentage of heavy drinking days after 6 months of treatment in heavy drinking individuals with an alcohol use disorder and a specific genetic profile, as determined via a CDx.

• This genotypic profile is located in the serotonin transporter and serotonin-AB receptor complex.

• Adverse events (AEs) of AD04 correspond to those of placebo

• Combining AD04 with psychosocial intervention may favorably change the way AUD disease is viewed and increase the demand for treatment for many people who would not otherwise consider it.

“The results highlighted in the publication underscore the promise of AD04, with the incorporation of a CDx, as an important advancement in the field of precision medicine. This approach is critical as AUD can be caused by various gene-environment interactions and does not manifest uniformly in all patients,” said Cary Claiborne, CEO of Adial. “We believe AUD patients will benefit more from precision treatments aimed at reducing alcohol consumption, such as AD04, as opposed to a one-size-fits-all approach. Recognition of the benefits of AD04 within this genetically and behaviorally defined patient population will allow Adial to continue to develop a 21st century-based approach to the treatment of this devastating disorder. AD04 offers a new strategy for managing AUD by reducing the potential harm of AUD, while reducing the perceived stigma of personal failure associated with the disorder.

The study examined the role of endophenotypes in predicting the effectiveness of AD04 for the treatment of AUD and found that specific genotypes affecting the serotonin transporter and the serotonin-AB receptor complex are predictive of the ability of AD04 to reduce the number of days of heavy drinking in patients with AUD. In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as “heavy drinkers” (on average <10 drinks per drinking day) saw a reduction in the monthly percentage of heavy drinking days. of alcohol after 6 months of treatment. . Additional analysis revealed that patients treated with AD04 had minimal AEs comparable to placebo treatment, high treatment adherence, and minimal discontinuation rate. The authors further noted that there are no studies in the alcohol literature in which an effective drug has an AE profile similar to that of a placebo.

The story continues

About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for addiction and related disorders. The Company’s lead investigational new drug, AD04, is a genetically targeted serotonin 3 receptor antagonist, a therapeutic agent for the treatment of alcohol use disorder (AUD) in patients who drink heavy alcohol . It was recently the subject of the Company’s pivotal phase 3 ONWARD™ clinical study. trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s companion diagnostic genetic test. ONWARD has shown promising results in reducing alcohol consumption in patients who drink heavily, without any obvious safety or tolerability concerns. AD04 would also 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 United States federal securities laws. These statements are based on various facts and derived from numerous material assumptions and are subject to known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements. , expressed or implied. by these forward-looking statements. Statements preceded by, followed by or otherwise including the words “believes”, “expects”, “anticipates”, “intends”, “projects”, “estimates”, “plans” and similar expressions or future or conditional verbs such as “will”, “should”, “would”, “could” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include what precedes. Forward-looking statements include statements regarding the potential use of AD04 as a precision medicine for the treatment of AUD, combining AD04 with a psychosocial intervention favorably changing the way AUD disease is viewed and increasing the demand for treatment for many people who would not have considered it otherwise. patients struggling with AUD may benefit more from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one-size-fits-all approach, recognizing the benefits of AD04 within this genetically-based patient population and behaviorally defined, allowing Adial to continue to develop a 21st century approach to the treatment of this devastating disorder, AD04 offering a new strategy for managing AUD by reducing the potential harm of AUD while reducing the perceived stigma of AUD personal failure associated with the disorder and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. All forward-looking statements included herein reflect our current views and involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnership discussions, our ability to obtain regulatory approvals for the commercialization of product candidates or to comply with applicable regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to finance our activities research and development, our ability to complete clinical trials on time and achieve the desired results and expected benefits, regulatory limitations related to our ability to promote or market our product candidates for specific indications, acceptance of our product candidates to market and the successful development, commercialization or sale of our products, our ability to maintain our licensing agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our listing on Nasdaq. These risks should not be construed as exhaustive and should be read in conjunction with other cautionary statements 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 originally made. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in circumstances or otherwise, except as required by law.

Contact:
Crescendo Communications, LLC
David Waldman/Alexandra Schilt
Tel: 212-671-1020
Email: [email protected]