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Adial Pharmaceuticals Granted Key Patent From the United States Patent and Trademark Office

Adial Pharmaceuticals Granted Key Patent From the United States Patent and Trademark Office

Adial Pharmicals 获得了美国专利和商标局的关键专利
GlobeNewswire ·  2024/04/22 20:30

GLEN ALLEN, Va., April 22, 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 patent number 11957664 was issued April 16, 2024 by the United States Patent and Trademark Office. This patent expands Adial's intellectual property protection and covers the combination of the Company's proprietary genetic diagnostic to identify patients with specific genotypes for genetically targeted treatment of alcohol use disorder (AUD) and other drug dependencies, such as opioid use disorder (OUD), with the Company's lead investigational new drug product AD04.

弗吉尼亚州格伦艾伦,2024年4月22日(环球新闻专线)——专注于开发治疗和预防成瘾及相关疾病疗法的临床阶段生物制药公司艾迪尔制药公司(纳斯达克股票代码:ADIL)(“Adial” 或 “公司”)今天宣布,美国专利商标局于2024年4月16日发布了编号为11957664的专利。该专利扩大了Adial的知识产权保护,涵盖了该公司专有的基因诊断与该公司主要研究新药产品AD04相结合,该诊断旨在识别具有特定基因型的患者,用于酒精使用障碍(AUD)和其他药物依赖的基因靶向治疗,例如阿片类药物使用障碍(OUD)。

Cary Claiborne, CEO of Adial, commented, "We are proud to have secured this new patent, which covers important aspects of the combination of our proprietary genetic diagnostic and AD04 to treat AUD, OUD, and other drug dependencies. Importantly, we have identified specific genotypes that have responded with clinically meaningful changes in drinking behavior compared to placebo in the AD04 post hoc analysis, which represents an addressable market of approximately $40 billion in the U.S. alone. We believe our unique personalized approach can offer new hope to the millions affected by AUD, OUD and other addictive disorders such as obesity and gambling."

Adial首席执行官Cary Claiborne评论说:“我们很自豪能够获得这项新专利,该专利涵盖了我们专有的基因诊断与AD04相结合以治疗AUD、OUD和其他药物依赖的重要方面。重要的是,在AD04事后分析中,与安慰剂相比,我们已经确定了特定的基因型,这些基因型的饮酒行为发生了具有临床意义的变化,仅在美国就有约400亿美元的潜在市场。我们相信,我们独特的个性化方法可以为数百万受澳元、OUD和其他成瘾性疾病(例如肥胖和赌博)影响的患者带来新的希望。”

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 .

关于阿迪尔制药公司
Adial Pharmaceuticals是一家临床阶段的生物制药公司,专注于开发成瘾和相关疾病的治疗方法。该公司的主要研究性新药产品AD04是一种基因靶向血清素-3受体拮抗剂,用于治疗重度饮酒患者酒精使用障碍(AUD),最近在该公司ONWARD的关键性3期临床试验中进行了研究,该试验旨在对使用公司的伴随诊断基因测试确定的具有某些靶标基因型的受试者可能治疗澳元。ONWARD在减少大量饮酒患者的饮酒量方面显示出令人鼓舞的结果,没有明显的安全性或耐受性问题。AD04还被认为有可能治疗其他成瘾性疾病,例如阿片类药物使用障碍、赌博和肥胖。其他信息可在以下网址获得。

Forward-Looking Statements

前瞻性陈述

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 addressable market for AD04 representing approximately $40 billion in the U.S. alone, the Company's unique personalized approach offering new hope to the millions affected by AUD, OUD and other addictive disorders such as obesity and gambling 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 retain our key employees or maintain our Nasdaq listing, 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 statements 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.

本通信包含美国联邦证券法所指的某些 “前瞻性陈述”。此类陈述基于各种事实,并利用许多重要假设得出,并受已知和未知的风险、不确定性和其他因素的影响,这些因素可能导致实际业绩、业绩或成就与此类前瞻性陈述所表达或暗示的任何未来业绩、业绩或成就存在重大差异。前后跟或以其他方式包含 “相信”、“期望”、“预期”、“打算”、“项目”、“估计”、“计划” 等类似表达方式或未来或条件动词(如 “将”、“应该”、“将”、“可能” 和 “可能”)的陈述在本质上通常是前瞻性的,而不是历史事实,尽管并非所有前瞻性陈述都包括前述内容。前瞻性陈述包括有关AD04潜在市场的陈述,仅在美国就有约400亿美元,该公司独特的个性化方法为数百万受澳元、OUD和其他成瘾性疾病(例如肥胖和赌博)影响的患者带来了新的希望,以及AD04治疗阿片类药物使用障碍、赌博和肥胖等其他成瘾性疾病的潜力。此处包含的任何前瞻性陈述都反映了我们当前的观点,它们涉及某些风险和不确定性,其中包括:我们推行监管战略的能力、推进持续合作讨论的能力、我们获得监管部门批准以实现候选产品商业化或遵守现行监管要求的能力、我们开发战略合作机会和维持合作的能力、我们获得或维持为研究提供资金所必需的资本或补助金的能力,以及开发活动,我们留住关键员工或维持在纳斯达克上市的能力,我们按时完成临床试验并按预期取得预期结果和收益的能力,与我们针对特定适应症推广或商业化候选产品的能力相关的监管限制,候选产品在市场上的接受以及我们产品的成功开发、营销或销售,我们维持许可协议的能力,专利资产的持续维护和增长以及我们的能力留住我们的关键员工或维持我们在纳斯达克的上市。不应将这些风险解释为详尽无遗,应与我们在截至2023年12月31日止年度的10-K表年度报告、随后的10-Q表季度报告以及向美国证券交易委员会提交的8-K表最新报告中的其他警示性声明一起阅读。任何前瞻性陈述仅代表其最初发表之日。除非法律要求,否则我们没有义务公开更新或修改任何前瞻性陈述,无论是由于新信息、未来事件、情况变化还是其他原因。

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

联系人:
克雷森多通讯有限责任公司
大卫·沃尔德曼/亚历山德拉·席尔特
电话:212-671-1020
电子邮件:adil@crescendo-ir.com


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