Boudicca will support and advise Adial on its companion diagnostic genetic test to ensure compliance with FDA guidelines

GLEN ALLEN, Va., Aug. 13, 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 addiction and related disorders, announced a collaboration with Boudicca Dx, LLC, a global precision medicine testing accelerator.

Under the agreement, Boudicca will support Adial in advancing its technical and regulatory strategy for the Company's companion diagnostic genetic test, to ensure it is validated both technically and clinically per FDA guidelines as part of Adial's regulatory strategy for its lead investigational asset, AD04, a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD). Adial's companion diagnostic is intended to accompany AD04 in identifying potential patients, including recruitment for the Company's planned Phase 3 program.

Cary Claiborne, President and Chief Executive Officer of Adial commented, "As we continue to prepare for the Phase 3 study for AD04, this agreement with Boudicca Dx is another key component toward achieving clinical success and is expected to support our next FDA interaction. Kelly Gordon, the Chief Executive Officer and founder of Boudicca Dx, along with her team, are the ideal partners for Adial to develop a comprehensive clinical, regulatory and commercial strategy for the AD04 companion diagnostic. Our mission is to bring a first in class precision medicine to the treatment of AUD, and having our companion diagnostic validated by the FDA is a critical step in the process."

Kelly Gordon commented, "The Boudicca Dx team is excited to support the development of a first-in-class companion diagnostic test for AD04, a precision medicine designed to treat patients with Alcohol Use Disorder. This disease affects more than 30 million people in the US alone and causes 3 million deaths worldwide each year. There is a high unmet need for a targeted therapy and its companion diagnostic test."

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 .

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 Boudicca supporting us in advancing our technical and regulatory strategy, our companion diagnostic accompanying AD04 in identifying potential patients, including recruitment for our planned Phase 3 program, continuing to prepare for the Phase 3 study for AD04, the agreement with Boudicca being another key component toward achieving clinical success and supporting our next FDA interaction. 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 companion diagnostic being able to accompany AD04 in identifying potential patients, including recruitment for our planned Phase 3 program, our ability to prepare and commence the planned Phase 3 program, our agreement with Boudicca supporting our next FDA interaction and clinical success, 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