Adial Pharmaceuticals Signs Agreement with Boudicca Dx to Advance Regulatory Strategy for Companion Diagnostic Genetic Test for AD04

Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL) has partnered with Boudicca Dx to advance the regulatory strategy for its companion diagnostic genetic test. This test is designed to accompany AD04, Adial's lead investigational asset for Alcohol Use Disorder (AUD) treatment. Boudicca Dx will support Adial in ensuring the test's compliance with FDA guidelines, a important step in Adial's regulatory strategy and preparation for its planned Phase 3 program.

The collaboration aims to validate the companion diagnostic both technically and clinically, supporting patient identification and recruitment for AD04 trials. This partnership is seen as a key component in Adial's mission to develop a first-in-class precision medicine for AUD treatment, addressing a significant unmet need in a disease affecting over 30 million people in the US and causing 3 million deaths worldwide annually.

Positive

• Partnership with Boudicca Dx to advance regulatory strategy for companion diagnostic test
• Preparation for Phase 3 study of AD04 for Alcohol Use Disorder treatment
• Potential development of first-in-class precision medicine for AUD

Negative

• None.

Insights

Medical Research Analyst

This collaboration marks a significant step towards advancing AD04, a potential breakthrough in Alcohol Use Disorder (AUD) treatment. The partnership with Boudicca Dx to develop a companion diagnostic test is important for several reasons:

• It enables precise patient identification, potentially improving clinical trial outcomes and future treatment efficacy.
• FDA validation of the diagnostic test strengthens Adial's regulatory strategy, potentially expediting the approval process.
• This approach aligns with the growing trend of personalized medicine in addiction treatment, addressing a critical gap in current AUD therapies.

However, investors should note that success is not guaranteed. The Phase 3 trial and FDA approval are still significant hurdles. The market potential is substantial, given the 30 million affected individuals in the US alone, but competition and adoption rates will be key factors to monitor.

Regulatory Affairs Specialist

Adial's partnership with Boudicca Dx is a strategic move to navigate the complex FDA regulatory landscape for companion diagnostics. Key points to consider:

• The FDA has stringent requirements for validating companion diagnostics, which are critical for the approval of targeted therapies like AD04.
• Boudicca's expertise could potentially streamline the regulatory process, reducing time and costs associated with FDA interactions.
• A successfully validated companion diagnostic could provide Adial with a competitive advantage in the AUD treatment market.

However, the regulatory path for novel companion diagnostics can be challenging and time-consuming. Investors should be prepared for potential delays or additional studies if required by the FDA. The success of this strategy could significantly impact Adial's timeline to market and overall valuation.

Market Research Analyst

Adial's focus on developing a precision medicine approach for AUD treatment positions them uniquely in a large, underserved market. Key market considerations include:

• The global AUD treatment market is substantial, with 3 million deaths worldwide annually highlighting the urgent need for effective therapies.
• Precision medicine in addiction treatment is an emerging trend, potentially offering Adial first-mover advantage.
• The companion diagnostic could create a high barrier to entry for competitors, potentially securing a significant market share if AD04 proves successful.

However, market adoption of new addiction treatments can be slow and healthcare provider education will be crucial. The success of AD04 and its companion diagnostic could reshape the AUD treatment landscape, but investors should be aware of the long-term nature of this potential market transformation.

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 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 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

FAQ

What is the purpose of Adial Pharmaceuticals' partnership with Boudicca Dx?

Adial Pharmaceuticals (NASDAQ: ADIL) has partnered with Boudicca Dx to advance the regulatory strategy for its companion diagnostic genetic test, ensuring compliance with FDA guidelines for AD04, their investigational treatment for Alcohol Use Disorder (AUD).

What is AD04 and what condition does it target?

AD04 is Adial Pharmaceuticals' lead investigational asset. It is a genetically targeted, serotonin-3 receptor antagonist therapeutic agent designed for the treatment of Alcohol Use Disorder (AUD).

How many people are affected by Alcohol Use Disorder according to the press release?

According to the press release, Alcohol Use Disorder affects more than 30 million people in the US alone and causes 3 million deaths worldwide each year.

What is the significance of the companion diagnostic test for Adial Pharmaceuticals (ADIL)?

The companion diagnostic test is important for Adial Pharmaceuticals (ADIL) as it will help identify potential patients for AD04 treatment and support recruitment for the planned Phase 3 program. It's a key component in developing a first-in-class precision medicine for AUD treatment.