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Adial Pharmaceuticals Receives Notice of Allowance for U.S. Patent Covering Expanded Genotype Combinations Identified Using the Company’s Genetic Diagnostic for Addiction Treatment

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Adial Pharmaceuticals (NASDAQ: ADIL) has received a Notice of Allowance from the United States Patent and Trademark Office for a new patent. This patent will expand Adial's intellectual property protection for its lead investigational drug, AD04, designed to treat alcohol use disorder (AUD). The patent covers additional genotype combinations identified through the Company's proprietary genetic diagnostic tool, enhancing AD04's precision medicine approach.

Cary Claiborne, CEO of Adial Pharmaceuticals, stated that this milestone broadens their patent estate and provides greater flexibility in advancing AD04. He emphasized the company's commitment to delivering innovative, genetically-targeted treatments for addiction. The patent notification reinforces Adial's focus on using cutting-edge science to develop more effective treatments with fewer side effects for those affected by addiction.

Positive
  • Received Notice of Allowance for a new U.S. patent
  • Expands intellectual property protection for lead drug AD04
  • Covers additional genotype combinations for genetic diagnostic tool
  • Enhances precision medicine approach for alcohol use disorder treatment
Negative
  • None.

Insights

This patent allowance significantly strengthens Adial Pharmaceuticals' position in the addiction treatment space. The expanded coverage for genotype combinations enhances the potential efficacy and market reach of their lead drug candidate, AD04, for alcohol use disorder (AUD). This precision medicine approach, utilizing genetic diagnostics, could lead to more targeted and effective treatments.

The implications for investors are multi-faceted:

  • Increased intellectual property protection potentially extends the commercial lifespan of AD04
  • Enhanced market differentiation through genetically-targeted treatments
  • Potential for improved clinical outcomes, which could lead to higher adoption rates if approved
  • Expanded patent estate may increase the company's valuation and attractiveness for partnerships or acquisitions

However, it's important to note that while this is a positive development, the drug is still investigational and faces regulatory hurdles before potential commercialization. The 6.2 million market cap suggests the company is still in early stages and investors should consider the risks associated with clinical-stage biopharmaceuticals.

Expands patent estate covering Adial’s unique molecular genetic approach to diagnosing and potentially treating alcohol and drug dependence

GLEN ALLEN, Va., Oct. 17, 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, today announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a new patent.

The patent, once issued, will expand Adial's intellectual property protection around its lead investigational drug, AD04, which is designed to treat alcohol use disorder (AUD). The new patent covers additional genotype combinations identified through the Company’s proprietary genetic diagnostic tool, further enhancing the precision medicine approach of AD04.

“This Notice of Allowance represents an important milestone for Adial as we continue to broaden our patent estate,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Securing protection for these additional genotype combinations provides us with greater flexibility as we advance AD04 and reinforces our commitment to delivering innovative, genetically-targeted treatments for addiction. This patent notification is a further testament to our commitment to harnessing cutting-edge science for the betterment of countless lives affected by addiction. By understanding the genetic factors that play a role in addiction, we believe we can pave the way for treatments that are more effective and have fewer side effects.”

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction 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 proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy 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.

If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change in the millions of patients who are struggling with addiction.

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 advancing AD04 and delivering innovative, genetically-targeted treatments for addiction, harnessing cutting-edge science for the betterment of countless lives affected by addiction, paving the way for treatments that are more effective and have fewer side effects by understanding the genetic factors that play a role in addiction 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.

Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: ADIL@crescendo-ir.com


FAQ

What new patent has Adial Pharmaceuticals (ADIL) received a Notice of Allowance for?

Adial Pharmaceuticals has received a Notice of Allowance for a U.S. patent covering expanded genotype combinations identified using the company's genetic diagnostic for addiction treatment, specifically enhancing their lead drug AD04 for alcohol use disorder.

How does the new patent benefit Adial Pharmaceuticals' (ADIL) drug development?

The new patent expands Adial's intellectual property protection for AD04, provides greater flexibility in advancing the drug, and reinforces their precision medicine approach by covering additional genotype combinations identified through their proprietary genetic diagnostic tool.

What is the significance of Adial Pharmaceuticals' (ADIL) genetic approach to addiction treatment?

Adial's genetic approach aims to develop more effective treatments with fewer side effects by understanding the genetic factors that play a role in addiction. This precision medicine approach could potentially improve outcomes for patients with alcohol use disorder and other addictions.

Adial Pharmaceuticals, Inc

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