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InMed Pharmaceuticals Announces Favorable Behavioral Outcomes With INM-901 in Long-Term Preclinical Alzheimer's Disease Study, Confirming Previous Short-Term Pilot Study Data

InMed Pharmaceuticals Announces Favorable Behavioral Outcomes With INM-901 in Long-Term Preclinical Alzheimer's Disease Study, Confirming Previous Short-Term Pilot Study Data

InMed Pharmaceuticals宣布通过长期临床前期阿尔茨海默病研究,INm-901呈现出有益行为结果,确认之前的短期试验数据。
InMed Pharmaceuticals ·  07/30 00:00
  • Results confirm improvements in cognitive function, memory and locomotor activity
  • Achieved statistical significance in certain behavioral assessments
  • Additional molecular analyses ongoing to elucidate INM-901 mechanisms of action
  • 结果证实认知功能、记忆力和运动活动有所改善
  • 在某些行为评估中取得了统计学意义
  • 正在进行更多分子分析,以阐明INM-901的作用机制

Vancouver, British Columbia–(Newsfile Corp. – July 30, 2024) – InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced positive results from initial data sets from a long-term (7 months of dosing) in vivo preclinical Alzheimer's Disease ("AD") study of INM-901 which confirms previously reported findings from a short-term (3 months of dosing) pilot study, as disclosed in the Company's prior press release dated April 4, 2024.

不列颠哥伦比亚省温哥华——(Newsfile Corp.,2024年7月30日)——专注于开发针对大量未满足医疗需求疾病的专有小分子候选药物管道的制药公司InMed Pharmicals Inc.(纳斯达克股票代码:INM)(“InMed” 或 “公司”)今天宣布了一项长期(7个月的剂量)体内阿尔茨海默氏病(“AD”)临床前研究的初始数据集的积极结果 M-901证实了先前报告的短期(3个月给药)试点研究的结果,正如该公司此前披露的那样2024 年 4 月 4 日的新闻稿。

Similar to the short-term pilot study, this long-term dosing study was conducted using the 5xFAD amyloidosis model with extended dosing duration and increased sample size as compared to the short-term study. This long-term study had four groupings:

与短期试点研究类似,这项长期给药研究是使用5xFAD淀粉样变模型进行的,与短期研究相比,给药时间延长,样本量增加。这项长期研究分为四组:

  1. Untreated disease-free group;
  2. INM-901-treated disease-free group;
  3. Placebo-treated Alzheimer's Disease (amyloidosis) group; and
  4. INM-901-treated Alzheimer's Disease (amyloidosis) groups with two dosing levels.
  1. 未经治疗的无病组;
  2. INM-901 治疗的无病组;
  3. 安慰剂治疗的阿尔茨海默病(淀粉样变性)组;以及
  4. INM-901 治疗的阿尔茨海默病(淀粉样变性)组有两种剂量水平。

It is important to note that disease severity increases with advancing age in this preclinical amyloidosis model such that groups in the long-term study had more advanced AD than those in the previous short-term pilot study.

值得注意的是,在这个临床前淀粉样变模型中,疾病的严重程度随着年龄的增长而增加,因此长期研究中的人群的AD晚期比之前的短期试点研究中的组更晚期。

The study included an assessment of several behavioral criteria across the four study groupings:

该研究包括对四个研究组的几种行为标准的评估:

  • Novel Object Recognition Test evaluating cognitive function and memory;
  • Open Field Test evaluating general locomotor activity level;
  • Elevated and Zero Maze Tests measuring anxiety-related behavior;
  • Barnes Maze Test measuring spatial learning and memory; and
  • Acoustic Startle Test measuring sound awareness.
  • 评估认知功能和记忆的新型物体识别测试;
  • 评估一般运动活动水平的露天实地测试;
  • 高架和零迷宫测试可衡量与焦虑相关的行为;
  • Barnes Maze Test 测量空间学习和记忆;以及
  • 声学惊吓测试测量声音感知能力。

All assessments of the INM-901-treated AD groups showed a positive trend towards behaviour similar to the untreated disease-free group, with most assessments demonstrating a clear dose response. Furthermore, INM-901-treated AD groups achieved a statistically significant improvement in certain behavior criteria in comparison to the placebo-treated AD groups. These results not only supported but in several instances improved upon the prior short-term pilot study outcomes.

对接受INM-901治疗的AD组的所有评估都显示出与未经治疗的无病组相似的行为呈积极趋势,大多数评估显示出明显的剂量反应。此外,与安慰剂治疗的AD组相比,接受INM-901治疗的AD组在某些行为标准方面取得了统计学上的显著改善。这些结果不仅支持了先前的短期试点研究结果,而且在某些情况下有所改善。

Dr. Eric Hsu, InMed's Senior Vice President of Preclinical Research and Development, stated; "We are highly encouraged by the initial data sets from this long-term dosing study, which support the previously observed improvements in behavioral outcomes seen in our initial short-term preclinical Alzheimer's proof-of-concept study. INM-901 continues to demonstrate potential by targeting multiple biological pathways linked to Alzheimer's Disease and may have potential to address the critical need for effective treatments."

InMed临床前研究与开发高级副总裁Eric Hsu博士表示:“这项长期剂量研究的初始数据集令我们深受鼓舞,这些数据集支持了先前在我们最初的短期临床前阿尔茨海默氏症概念验证研究中观察到的行为结果的改善。INM-901通过靶向与阿尔茨海默氏病相关的多种生物通路继续显示出潜力,并有可能满足对有效治疗的迫切需求。”

The Company is conducting further molecular analyses to better define the mechanisms of action and potential role of INM-901 in AD treatment. The analyses will focus on the following areas using mRNA, protein and histological measurements:

该公司正在进行进一步的分子分析,以更好地定义INM-901在AD治疗中的作用机制和潜在作用。使用mRNA、蛋白质和组织学测量,分析将侧重于以下领域:

  • Receptor engagement: CB1/CB2 and PPAR;
  • Neuroinflammation: various cytokines and inflammatory marker protein level;
  • Neurogenesis: assess markers for neuronal differentiation and neuronal function; and
  • Neuroprotection: evaluating stress responses and cellular growth/survival.
  • 受体接合:CB1/CB2 和 PPAR;
  • 神经炎症:各种细胞因子和炎症标志物蛋白水平;
  • 神经发生:评估神经元分化和神经元功能的标志物;以及
  • 神经保护:评估压力反应和细胞生长/存活。

Additionally, the development of the chemistry, manufacturing, and controls (CMC) for both the drug substance and the drug product formulation is ongoing, with GLP studies in the planning stages to support an IND submission.

此外,药物物质和药品配方的化学、制造和对照(CMC)的开发正在进行中,GLP研究处于规划阶段,以支持提交IND。

INM-901 Program to date

迄今为止的 INM-901 计划

Research and development activities to date have demonstrated the potential of INM-901 to target several biological pathways associated with AD, including positive pharmacological characteristics such as:

迄今为止的研发活动表明,INM-901有可能靶向与AD相关的几种生物途径,包括积极的药理特性,例如:

  • A preferential signaling agonist for CB1/CB2 and impacts PPAR signaling pathways;
  • Blood/brain barrier (BBB) penetration; may be deliverable via oral administration;
  • Demonstrated neuroprotective effects against amyloid-beta-induced cytotoxicity;
  • Demonstrated an ability to promote neurite outgrowth, signifying the potential to improve neuronal function;
  • Demonstrated reduced neuroinflammation and improved neuronal function; and
  • Molecular data supports observations from behavior studies demonstrating improvements in locomotor activity, cognition and memory.
  • CB1/CB2 的优先信号激动剂,可影响 PPAR 信号通路;
  • 血液/脑屏障(BBB)穿透;可通过口服给药;
  • 表现出对β淀粉样蛋白诱发的细胞毒性的神经保护作用;
  • 表现出促进神经元生长的能力,表明有可能改善神经元功能;
  • 表现出减少神经炎症和改善神经元功能;以及
  • 分子数据支持行为研究的观察,这些研究表明运动活动、认知和记忆有所改善。

About InMed:

关于 inMed:

InMed Pharmaceuticals is a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed's pipeline consists of three separate programs in the treatment of Alzheimer's, ocular and dermatological indications. Together with our subsidiary BayMedica, we are a global leader in the manufacturing, development and commercialization of rare cannabinoids and proprietary small molecule drug candidates. For more information, visit .

InMed Pharmaceuticals是一家制药公司,专注于开发针对CB1/CB2受体的专有小分子候选药物管道。InMed的产品线包括三个单独的项目,分别治疗阿尔茨海默氏症、眼部和皮肤病学适应症。我们与子公司BayMedica一起,是稀有大麻素和专有小分子候选药物的制造、开发和商业化的全球领导者。欲了解更多信息,请访问。

Investor Contact:
Colin Clancy
Vice President, Investor Relations
and Corporate Communications
T: +1 604 416 0999
E: [email protected]

投资者联系人:
科林·克兰西
投资者关系副总裁
和企业传播
电话:+1 604 416 0999
E: [电子邮件保护]

Cautionary Note Regarding Forward-Looking Information:

关于前瞻性信息的警示说明:

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "potential", "possible", "would" and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: the efficacy of INM-901, INM-901's ability to treat AD, marketability and uses for INM-901, the results of further studies into INM-901 and acceleration of the development of InMed's AD program as well as potential GLP studies or IND submissions.

本新闻稿包含适用证券法所指的 “前瞻性信息” 和 “前瞻性陈述”(统称为 “前瞻性信息”)。前瞻性陈述通常以 “期望”、“预期”、“相信”、“打算”、“潜力”、“可能”、“将” 等词语和类似表述来识别,但并非总是如此。此类陈述基于管理层当前的预期,本质上涉及许多已知和未知的风险、不确定性和假设,其中许多是我们无法控制的。前瞻性信息基于管理层当前的预期和信念,存在许多风险和不确定性,这些风险和不确定性可能导致实际业绩与前瞻性陈述中描述的结果存在重大差异。在不限制上述内容的前提下,本新闻稿中的前瞻性信息包括但不限于以下方面的陈述:INM-901的功效、INM-901治疗AD的能力、INM-901的适销性和用途、对INM-901的进一步研究结果和加速InMed的AD项目开发以及潜在的GLP研究或IND申报。

Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. A complete discussion of the risks and uncertainties facing InMed's stand-alone business is disclosed in InMed's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on www.sec.gov.

此外,还有一些已知和未知的风险因素可能导致InMed的实际业绩、业绩或成就与本文所包含的前瞻性信息所表达或暗示的任何未来业绩、业绩或成就存在重大差异。InMed向美国证券交易委员会提交的10-K表年度报告以及其他在www.sec.gov上提交给美国证券交易委员会的文件中披露了对InMed独立业务面临的风险和不确定性的全面讨论。

All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.

此处的所有前瞻性信息均受本警示声明的全面限制,除非法律要求,否则InMed不承担任何修改或更新任何此类前瞻性信息或公开宣布为反映未来业绩、事件或发展而对本文包含的任何前瞻性信息进行任何修订的结果的义务。

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