Adial Pharmaceuticals Files New Patent Application to Protect Core Assets and Extend IP Exclusivity on Core Technology to 2044

Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL) has filed a new patent application for AD04, its lead investigational therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients. The patent, if granted, is expected to protect Adial's core assets until at least 2044. This application follows an extensive review of data and information, initiated after the company hired new patent counsel to strengthen its intellectual property portfolio.

AD04 is a genetically targeted, serotonin-3 receptor antagonist designed to treat AUD in patients consuming 10 or more drinks per drinking day. The company is currently advancing the AD04 program with ongoing pharmacokinetics studies. CEO Cary Claiborne emphasized the importance of this patent application in extending protection for Adial's core assets.

Positive

• Filed new patent application for AD04, potentially extending core asset protection to 2044
• Ongoing advancement of AD04 program with pharmacokinetics studies

Negative

• None.

Insights

Intellectual Property Lawyer

The filing of a new patent application by Adial Pharmaceuticals for their lead investigational drug AD04 is a significant move to strengthen their intellectual property position. This action could have substantial implications for the company's future:

• Extended Market Exclusivity: If granted, the patent would protect Adial's core assets until at least 2044, potentially providing the company with a 20-year monopoly on their technology. This extended period of exclusivity could significantly enhance the company's ability to monetize their innovation.
• Strategic IP Management: The decision to file this patent application after hiring new patent counsel demonstrates a proactive approach to IP strategy. It suggests that Adial is actively working to maximize the value of its intellectual property portfolio.
• Competitive Advantage: A strong patent position can serve as a barrier to entry for competitors, potentially giving Adial a significant edge in the Alcohol Use Disorder (AUD) treatment market.

However, it's important to note that patent applications are not guaranteed to be approved. The success of this application will depend on factors such as the novelty and non-obviousness of the claims. Additionally, even if granted, patents can be challenged by competitors. Investors should monitor the progress of this application through the patent office and any potential challenges that may arise.

Pharmaceutical Industry Analyst

Adial Pharmaceuticals' move to file a new patent application for AD04 is a strategic step that could significantly impact the company's market position and valuation:

• Pipeline Protection: AD04, as Adial's lead investigational drug for Alcohol Use Disorder (AUD), represents a important asset. Extending patent protection to 2044 could secure long-term revenue potential, assuming the drug receives FDA approval and achieves market success.
• Investor Confidence: This patent filing may boost investor confidence by demonstrating the company's commitment to protecting its intellectual property and maximizing the commercial potential of its research and development efforts.
• Potential for Partnerships or Acquisitions: A stronger patent position could make Adial a more attractive partner for larger pharmaceutical companies or a potential acquisition target, possibly leading to strategic alliances or exit opportunities for investors.

However, it's important to consider that the value of this patent application is contingent on the success of AD04 in clinical trials and its eventual market performance. The AUD treatment market is competitive and the ultimate commercial success of AD04 will depend on factors beyond patent protection, such as efficacy, safety profile and pricing strategy. Investors should closely monitor the progress of AD04's clinical development alongside this patent application.

Expected New Patent Based on Extensive Review of Data and Information

GLEN ALLEN, Va., July 31, 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 the filing of a new patent application for 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 patent, assuming granted, is expected to protect Adial’s core assets through at least 2044.

Cary Claiborne, President and Chief Executive Officer of Adial commented, “As we continue to advance the AD04 program with the progress of our pharmacokinetics study of AD04, this new patent application and it’s expected approval will extend protection of the core assets of Adial out to at least 2044. This application is the result of an extensive examination of data and information which occurred after Adial hired new patent counsel to bolster and leverage the company’s intellectual property portfolio.”  

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 Company’s new patent application for AD04, the patent protecting Adial’s core assets out to at least 2044 once granted, the patent being granted ,continuing to advance the AD04 program 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 protect our core assets with the new patent, 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' new patent application for AD04?

Adial Pharmaceuticals filed a new patent application for AD04 to protect its core assets and extend intellectual property exclusivity on its core technology until at least 2044.

What is AD04 designed to treat according to Adial Pharmaceuticals (ADIL)?

AD04 is designed to treat Alcohol Use Disorder (AUD) in heavy drinking patients, defined as those consuming 10 or more drinks per drinking day.

How does Adial Pharmaceuticals (ADIL) describe AD04 in terms of its mechanism?

Adial Pharmaceuticals describes AD04 as a genetically targeted, serotonin-3 receptor antagonist therapeutic agent for the treatment of Alcohol Use Disorder.

What ongoing studies is Adial Pharmaceuticals (ADIL) conducting for AD04?

Adial Pharmaceuticals is currently advancing the AD04 program with ongoing pharmacokinetics studies.