Adial Pharmaceuticals Awarded New Patent from the United States Patent and Trademark Office
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Insights
The issuance of a patent is a critical step in the protection of intellectual property for biopharmaceutical companies. The patent for AD04 not only adds a layer of exclusivity for Adial Pharmaceuticals but also potentially extends the commercial lifespan of the drug by preventing competitors from creating generic versions. This exclusivity is vital for recouping the significant investment required for drug development. Furthermore, the ability of AD04 to target the serotonin transporter gene suggests a novel mechanism of action that may offer advantages over existing treatments for opioid use disorder (OUD), which is a market with a high unmet medical need.
From a patent perspective, the strength of the claim lies in its specificity to the serotonin transporter gene. This could limit the avenues for competitors to design around the patent, thereby solidifying Adial's position in the market if AD04 is approved. However, the actual commercial impact will depend on the drug's efficacy and safety profile, which are determined in clinical trials.
Opioid use disorder represents a significant market opportunity due to the ongoing opioid epidemic. The development of new treatments like AD04 is closely watched by investors and healthcare providers alike. The uniqueness of AD04 targeting the serotonin transporter gene may differentiate it from other therapies and could be a key selling point if the drug reaches the market. The patent announcement may stimulate investor confidence in Adial Pharmaceuticals, as it suggests a commitment to expanding the drug's indications beyond alcohol use disorder.
It is important to analyze the potential market size for AD04, considering the prevalence of OUD and the competitive landscape. If AD04 proves to be effective, it could capture a significant share of the market, which would have a positive impact on Adial's revenue and growth prospects. The long-term benefits, however, hinge on successful clinical trials and eventual FDA approval. The patent news should be seen as a positive development, but with the understanding that commercial success is not guaranteed and is contingent upon future regulatory and clinical milestones.
The targeting of the serotonin transporter gene by AD04 is a promising approach in the treatment of OUD, given the role of serotonin in addiction pathways. Current treatments for OUD, such as methadone and buprenorphine, primarily target the opioid receptors. A drug that works through a different mechanism, such as modulating the serotonin system, could be beneficial in cases where existing treatments are inadequate.
However, the clinical implications of this new patent will ultimately depend on the outcomes of clinical trials assessing AD04's safety and efficacy. If AD04 is shown to be effective, it could represent a significant advancement in addiction medicine. It's essential to consider the potential impact on patient care, including how this treatment could be integrated into existing treatment protocols and its accessibility for patients. The patent news is a step forward, but the real-world impact on patient outcomes remains to be seen.
New patent strengthens Adial’s patent portfolio and covers AD04’s unique ability to target the serotonin transporter gene for the potential treatment of opioid use disorder
CHARLOTTESVILLE, Va., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“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 11,905,562 was issued on February 20, 2024 by the United States Patent and Trademark Office. The patent covers the Company’s lead investigational new drug product, AD04, and its ability to target the serotonin transporter gene for the potential treatment of opioid use disorder (OUD).
“We are proud to be awarded another important patent that broadens our Intellectual Property portfolio and covers meaningful aspects of our lead asset, AD04, including its unique ability to target the serotonin transporter gene,” commented Cary Claiborne, CEO of Adial Pharmaceuticals. “We believe AD04 has significant potential to treat OUD and other drug dependencies in addition to our initial indication of alcohol use disorder. We remain focused on advancing AD04 toward commercialization for the treatment of alcohol use disorder and look forward to advancing OUD and other indications in the future.”
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 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.
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 AD04 having significant potential to treat opioid use disorder and other drug dependencies in addition to the initial indication of alcohol use disorder, advancing AD04 toward commercialization for the treatment of alcohol use disorder, advancing OUD and other indications in the future 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 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, 2022, 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
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