Adial Pharmaceuticals announces a new patent for treating addiction using its drug AD04 in genetically identified patients.
Quiver AI Summary
Adial Pharmaceuticals, Inc. announced the issuance of patent number 12,274,692 by the USPTO on April 15, 2025, which protects a new method for treating alcohol-related diseases and opioid-related disorders with their investigational drug, AD04, tailored for genetically identified patients. This patent enhances Adial's intellectual property by covering the use of AD04 based on specific genetic markers linked to treatment efficacy, including variations in genes associated with serotonin. The patent encompasses various alcohol-related disorders, highlighting a precision medicine approach that aims to improve treatment outcomes for patients with Alcohol Use Disorder (AUD) and other addictive disorders. CEO Cary Claiborne expressed the company’s commitment to advancing AD04's development, emphasizing the need for effective personalized addiction treatments.
Potential Positives
- The issuance of patent number 12,274,692 reinforces Adial Pharmaceuticals' intellectual property portfolio, which is vital to maintaining a competitive edge in the biopharmaceutical industry.
- The patent covers a novel method of treating alcohol-related diseases and opioid-related disorders, potentially enhancing treatment options for these significant health issues.
- By tailoring treatments based on genetic markers, Adial is pioneering a precision medicine approach, which could lead to improved patient outcomes and increased efficacy of their investigational drug AD04.
- The announcement of promising results from the ONWARD™ pivotal Phase 3 clinical trial strengthens the case for AD04 as a viable treatment for Alcohol Use Disorder (AUD), demonstrating no overt safety concerns.
Potential Negatives
- The press release emphasizes the uncertainty and risks associated with the company's future, particularly regarding the ability to successfully complete clinical trials and obtain regulatory approvals for commercialization.
- The mention of multiple risks in the forward-looking statements could raise concerns among investors about the company's ability to achieve its goals and maintain its financial stability.
- There is no indication of current sales or market reception of AD04, which could suggest potential difficulties in translating the clinical success into commercial viability.
FAQ
What recent patent has Adial Pharmaceuticals received?
Adial Pharmaceuticals announced the issuance of patent number 12,274,692 for a novel method of treating alcohol-related diseases and opioid-related disorders using AD04.
How does AD04 work as a precision medicine?
AD04 is administered based on specific genetic markers, targeting patients with serotonin-related gene variations for effective treatment of addiction.
What types of disorders can AD04 potentially treat?
AD04 is being developed for Alcohol Use Disorder (AUD), Opioid Use Disorder, and other addictive disorders like gambling and obesity.
What was the outcome of the ONWARD clinical trial?
The ONWARD Phase 3 clinical trial for AD04 showed promising results in reducing heavy drinking in patients without major safety concerns.
How can partnerships be formed with Adial Pharmaceuticals?
Interested parties can reach out to Adial at [email protected] to explore partnership opportunities for addressing addiction treatment challenges.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ADIL Hedge Fund Activity
We have seen 6 institutional investors add shares of $ADIL stock to their portfolio, and 4 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RENAISSANCE TECHNOLOGIES LLC added 47,613 shares (+inf%) to their portfolio in Q4 2024, for an estimated $48,089
- TWO SIGMA SECURITIES, LLC removed 27,115 shares (-100.0%) from their portfolio in Q4 2024, for an estimated $27,386
- CAMBRIDGE INVESTMENT RESEARCH ADVISORS, INC. removed 27,000 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $17,123
- CITADEL ADVISORS LLC added 21,238 shares (+63.8%) to their portfolio in Q4 2024, for an estimated $21,450
- UBS GROUP AG added 16,614 shares (+377.2%) to their portfolio in Q4 2024, for an estimated $16,780
- GEODE CAPITAL MANAGEMENT, LLC added 16,381 shares (+36.0%) to their portfolio in Q4 2024, for an estimated $16,544
- 1620 INVESTMENT ADVISORS, INC. added 3,600 shares (+inf%) to their portfolio in Q4 2024, for an estimated $3,636
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
GLEN ALLEN, Va., May 01, 2025 (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 patent number 12,274,692 was issued on April 15, 2025 by the United States Patent and Trademark Office (USPTO) covering a novel method of treating alcohol-related diseases and opioid-related disorders using AD04 in genetically identified patients.
This newly issued patent strengthens Adial’s intellectual property portfolio by covering the administration of AD04, the Company’s investigational drug, as a precision medicine approach for patients with specific genetic markers. The patent claims a method of treating addiction by administering a therapeutically effective amount of AD04 to patients with serotonin-related gene variations, including specific genotypes of HTR3A, HTR3B, and SLC6A4, such as the LL genotype of 5-HTTLPR in combination with variations in rs1150226, rs17614942, and rs1176713. The granted claims include specific genetic profiles associated with treatment efficacy and the corresponding dosing regimens. Specifically for AUD, the patent claims cover a method of treatment for a broad definition of alcohol related disorders including, but not limited to, disorders associated with alcohol use such as alcohol induced or associated anxiety, bi-polar, sexual dysfunction, sleep disorder, or gambling disorder as well as alcohol withdrawal.
“This patent represents yet another significant milestone for Adial Pharmaceuticals as we advance our mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “By identifying genetic markers associated with AD04 response, we are pioneering a precision medicine approach for AUD that has the potential to enhance treatment efficacy and improve patient outcomes. We remain committed to advancing AD04 through clinical development and regulatory pathways to address the urgent need for effective, personalized addiction treatments.”
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 ([email protected]) to discuss how our joint efforts can bring about positive change to 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 the Company’s mission to provide targeted treatments for individuals suffering from alcohol and opioid use disorders; and identifying genetic markers associated with AD04 response having the potential to enhance treatment efficacy and improve patient outcomes for AUD. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, future AD04 trials supporting AUO 4’s ability to enhance treatment efficacy and improve patient outcomes for AUD; 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, 2024, 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:
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