Patient dosing has concluded for the second and last cohort of the pharmacokinetics study of AD04
Topline results expected during the fourth quarter
GLEN ALLEN, Va., Aug. 07, 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, announced that the final patient has completed the last dose in the pharmacokinetics study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as < 10 drinks/drinking day). Topline results from both cohorts are expected to be announced during the fourth quarter of 2024.
Cary Claiborne, President and Chief Executive Officer of Adial, said, "Completion of dosing in the pharmacokinetics study for AD04 marks a significant milestone in our path toward initiating the Phase 3 clinical trial. This trial is intended to optimize dosing and, in turn, maximize the efficacy and safety of AD04 in patients with AUD. This achievement emphasizes our commitment to advancing AD04 and maximizing its likelihood of success, as a promising treatment for AUD. We believe this trial data will also play a key role as we advance ongoing partnership discussions."
"Our immediate focus will now shift to a thorough review of the important pharmacokinetic data gathered from this study. We are eager to analyze the insights and integrate them into our comprehensive development plan. Following the receipt of the topline results, which we anticipate in the fourth quarter, we will engage in detailed discussions with the FDA to ensure our path forward is well-aligned with regulatory expectations."
The single-center open-label relative bioavailability and dose proportionality study enrolled 30 healthy adult volunteers and will compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg, with or without food, against a reference standard product.
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 .
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 announcing topline results from both cohorts during the fourth quarter of 2024, the trial optimizing dosing and maximizing the efficacy and safety of AD04 in patients with AUD, advancing AD04 and maximizing its likelihood of success as a promising treatment for AUD, the trial data playing a key role as the Company advances ongoing partnership discussions, analyzing the insights from the trial and integrating them into the Company's comprehensive development plan, engaging in detailed discussions with the FDA to ensure the Company's path forward is well-aligned with regulatory expectations 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
第二组也是最后一组AD04药代动力学研究的患者给药已经结束
预计第四季度业绩将出炉
弗吉尼亚州格伦艾伦,2024年8月7日(GLOBE NEWSWIRE)——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Adial Pharmicals, Inc.(纳斯达克股票代码:ADIL)(“Adial” 或 “公司”)宣布,公司负责人AD04的药代动力学研究的最后一剂药物基于基因的靶向血清素-3 受体拮抗剂,用于治疗重度饮酒患者(定义为 < 10)酒精使用障碍(AUD)的治疗药物饮料/饮酒日)。这两个群体的头条业绩预计将在2024年第四季度公布。
Adial总裁兼首席执行官Cary Claiborne表示:“AD04药代动力学研究的完成标志着我们启动3期临床试验道路上的一个重要里程碑。该试验旨在优化剂量,进而最大限度地提高AD04对AUD患者的疗效和安全性。这一成就凸显了我们对推进AD04并最大限度地提高其成功可能性的承诺,将其作为一种有前途的澳元治疗方法。我们相信,在我们推进正在进行的合作讨论的过程中,这些试验数据也将发挥关键作用。”
“现在,我们的当务之急将转移到全面审查从这项研究中收集的重要药代动力学数据上。我们渴望分析这些见解并将其纳入我们的全面发展计划。在收到我们预计将在第四季度公布的主要业绩后,我们将与美国食品药品管理局进行详细讨论,以确保我们的前进道路与监管部门的预期完全一致。”
这项单中心开放标签的相对生物利用度和剂量比例研究招募了30名健康的成年志愿者,并将把AD04在口服剂量为0.33 mg(含或不含食物)时与参考标准产品进行比较。
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。
前瞻性陈述
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。前瞻性陈述包括关于公布两组在2024年第四季度的主要结果、优化AD04对澳元患者的剂量并最大限度地提高AD04的疗效和安全性的试验、推进AD04并最大限度地提高其作为澳元前景治疗的成功可能性的陈述、在公司推进正在进行的合作讨论、分析该试验的见解并将其纳入公司的全面发展计划、与之进行详细讨论的过程中,试验数据发挥了关键作用那个美国食品和药物管理局将确保公司的前进道路与监管预期以及AD04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)的潜力保持一致。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,市场对候选产品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,持续维护和增长我们的专利资产以及我们留住关键员工或维持在纳斯达克上市的能力。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。
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