Adial Pharmaceuticals received a patent for methods identifying genetic markers in addiction treatment, enhancing its investigational drug AD04.
Quiver AI Summary
Adial Pharmaceuticals, Inc. has announced the issuance of a new patent that enhances their methods for identifying and treating patients with genetic markers associated with substance use disorders using their investigational drug AD04. The patent was granted on February 11, 2025, and pertains specifically to the TT genotype of the serotonin transporter gene, which is linked to conditions like opioid dependence and alcohol use disorder. CEO Cary Claiborne emphasized the significance of this patent for advancing their mission to develop personalized addiction treatments, highlighting AD04's potential effectiveness for various addictions beyond alcohol use disorder. The company's recent pivotal Phase 3 ONWARD trial showed promising results in reducing heavy drinking, with no major safety concerns reported. Adial seeks to combine genetic diagnostics with their therapeutic solutions to improve outcomes for patients who do not respond well to traditional treatments.
Potential Positives
- The issuance of patent number 12,221,654 expands Adial's intellectual property portfolio related to methods for identifying and treating patients with specific genetic markers linked to substance use disorders.
- The patent supports the development of the company's investigational new drug, AD04, which has shown potential in clinical trials for treating opioid use disorder, alcohol dependence, and other addictive disorders.
- CEO Cary Claiborne emphasizes the significance of personalized treatment approaches in addressing addiction, aligning with current trends in precision medicine.
- Positive results from the ONWARD™ Phase 3 clinical trial reinforce the efficacy and safety profile of AD04 in reducing heavy drinking among targeted patient populations.
Potential Negatives
- The press release emphasizes forward-looking statements that are subject to numerous risks and uncertainties, which may lead to significant investor concerns about the company's ability to achieve its goals.
- The reliance on the genetic marker rs1042173 for treatment raises questions about the potential market limitations and the generalizability of treatment effectiveness for broader populations.
- The company’s status as a clinical-stage firm may create skepticism regarding the actual effectiveness of their investigational drug AD04, particularly given the competition in the addiction treatment sector.
FAQ
What is the significance of patent number 12,221,654 for Adial Pharmaceuticals?
This patent enhances methods for identifying patients with genetic markers linked to substance use disorders and the treatment using AD04.
What is AD04 and its potential uses?
AD04 is an investigational drug aimed at treating Alcohol Use Disorder and shows potential for other addictions like opioid use disorder.
How does the treatment method with AD04 work?
The treatment involves detecting specific genetic markers and administering AD04 to personalize care for addiction disorders.
What results did the ONWARD™ clinical trial for AD04 show?
The ONWARD™ trial indicated promising results in reducing heavy drinking without safety concerns for patients with targeted genotypes.
Where can I find more information about Adial Pharmaceuticals?
Additional information about Adial Pharmaceuticals and its research can be found on their official website at www.adial.com.
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 5 institutional investors add shares of $ADIL stock to their portfolio, and 7 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- UBS GROUP AG removed 79,201 shares (-94.7%) from their portfolio in Q3 2024, for an estimated $79,121
- RENAISSANCE TECHNOLOGIES LLC removed 34,346 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $34,311
- HRT FINANCIAL LP removed 29,228 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $29,198
- TWO SIGMA SECURITIES, LLC added 27,115 shares (+inf%) to their portfolio in Q3 2024, for an estimated $27,087
- GEODE CAPITAL MANAGEMENT, LLC added 19,592 shares (+75.7%) to their portfolio in Q3 2024, for an estimated $19,572
- CITADEL ADVISORS LLC added 8,524 shares (+34.4%) to their portfolio in Q3 2024, for an estimated $8,515
- 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., Feb. 12, 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 12,221,654 was issued on February 11, 2025, by the United States Patent and Trademark Office.
This patent expands the covered methods of identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the Company’s investigational new drug product. The treatment approach involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04. These treatment methods are tailored for individuals suffering from disorders such as opioid dependence, opioid abuse, alcohol dependence, and other related conditions.
“This patent is an important milestone for Adial Pharmaceuticals as we continue our mission to create innovative, personalized treatments for addiction,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Our research not only helps us understand the genetic underpinnings of addiction but also positions us to deliver solutions that are more effective and tailored to individual patients. We believe AD04 has significant potential to treat opioid use disorder and other drug dependencies in addition to our initial indication of alcohol use disorder. By combining genetic diagnostics with precision medicine, we aim to improve outcomes for patients who may not respond to traditional 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 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 creating innovative, personalized treatments for addiction, understanding the genetic underpinnings of addiction, positioning the Company to deliver solutions that are more effective and tailored to individual patients, AD04 having significant potential to treat opioid use disorder and other drug dependencies in addition alcohol use disorder, improving outcomes for patients who may not respond to traditional treatments by combining genetic diagnostics with precision medicine 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.
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