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InMed提供药物开发计划的最新进展——推进主要候选药物进入IND和临床试验阶段

InMed Provides Update on Pharmaceutical Development Programs - Advancing Lead Drug Candidates Towards IND and Clinical Trial

INN 等信源发布 2026-03-09 20:34

可切换为仅中文


Investing News Network

投资新闻网络

March 09, 2026

2026年3月9日

Advancing Alzheimer's and Age-Related Macular Degeneration Programs Toward FDA Engagement and IND-Enabling Activities

推进阿尔茨海默病和年龄相关性黄斑变性项目,迈向FDA参与和IND支持活动

Targeting Initiation of Phase 1 Clinical Trial in Alzheimer's Disease in 2027

计划于2027年启动阿尔茨海默病的1期临床试验

InMed Pharmaceuticals Inc.

InMed制药公司

(NASDAQ:

(纳斯达克:

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印度国家数学

) ('InMed' or the 'Company'), a pharmaceutical company focused on developing a pipeline of disease-modifying small molecule drug candidates that target CB1CB2 receptors, today provides a pharmaceutical development outlook for 2026.

)(“InMed”或“公司”),一家专注于开发针对CB1CB2受体的疾病修饰小分子药物候选管线的制药公司,今天提供了2026年的药物开发展望。

'Over the last several quarters, we made meaningful scientific and operational progress across our pipeline, particularly with

“在过去的几个季度中,我们在整个产品线中取得了有意义的科学和运营进展,特别是在

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-901, generating data that fundamentally strengthened its scientific rationale and strategic positioning in the Alzheimer's segment. These results support a differentiated approach to Alzheimer's disease that extends beyond single-target strategies. We further refined the program's direction and reinforced our conviction that targeting neuroinflammation is critical to addressing Alzheimer's disease progression,' commented Eric A.

“-901生成的数据从根本上增强了其在阿尔茨海默病领域的科学依据和战略定位。这些结果支持了一种超越单一靶点策略的阿尔茨海默病差异化方法。我们进一步细化了项目的方向,并坚定了我们的信念,即针对神经炎症是解决阿尔茨海默病进展的关键。”埃里克·A评论道。

Adams, InMed President and CEO..

亚当斯,InMed公司总裁兼首席执行官。

'Looking ahead in 2026, our primary focus is executing activities toward a pre-IND meeting with the FDA in Q3 to discuss the

‘展望2026年,我们的主要重点是执行在第三季度与FDA召开pre-IND会议的活动,讨论

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-901 program, which we believe will be a key inflection point as we work toward IND submission and initiation of a Phase 1 clinical trial in 2027. In parallel, we will continue developing

-901计划,我们认为这将是关键的转折点,因为我们正在朝着2027年提交IND和启动一期临床试验努力。同时,我们将继续开发

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-089 and plan for a pre-IND meeting in Q4 2026.'

-089,并计划在2026年第四季度召开pre-IND会议。

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-901 Program Outlook

-901 计划展望

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-901 is a proprietary, orally bioavailable, disease-modifying small molecule drug candidate that is a preferential CB1/CB2 signaling agonist and can cross the blood-brain barrier with a specific focus on treating neuroinflammation in Alzheimer's disease. InMed believes

-901 是一种专有的、口服生物可利用的、疾病修饰的小分子候选药物,是优先作用于CB1/CB2信号传导的激动剂,能够穿越血脑屏障,专注于治疗阿尔茨海默病中的神经炎症。InMed相信

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-901 is uniquely positioned within the evolving Alzheimer's disease treatment landscape as increasing scientific consensus suggests that the disease is driven by multiple, interrelated biological pathways, rather than a single pathogenic mechanism.

-901 在不断发展的阿尔茨海默病治疗领域中占据独特地位,因为越来越多的科学共识表明,该疾病是由多个相互关联的生物通路驱动的,而不是单一的致病机制。

InMed has generated preclinical evidence supporting that

InMed已经生成了支持这一观点的临床前证据

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-901 exerts a therapeutic effect by directly attenuating neuroinflammation, which functions as a primary pathogenic driver for the Alzheimer's disease progression rather than a secondary or a reactive effect. Additional data on neuroprotection and neuritogenesis of

-901通过直接减弱神经炎症发挥治疗作用,这种神经炎症是阿尔茨海默病进展的主要致病驱动因素,而不是次要或反应性效应。关于神经保护和神经突生成的更多数据

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-901 demonstrated a multifactorial mechanism of action, engaging several complementary pathways critical to mitigate neurodegeneration. By clarifying its focus, InMed strengthened the clinical and commercial rationale for

-901展示了多因素作用机制,参与了几个对减轻神经退行性疾病至关重要的互补途径。通过明确其重点,InMed加强了其临床和商业理由。

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-901 and positioned the program to pursue the most efficient and impactful path forward.

-901 并将程序定位为追求最高效和最有影响力的前进路径。

Scientific and Development Progress in 2025 include:

2025年的科学和发展进展包括:

Key Anti-Neuroinflammation Progress

关键抗神经炎症进展

In 5xFAD mouse model,

在5xFAD小鼠模型中,

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-901 significantly reduced inflammatory biomarkers IFN-γ, TNF-α, IL-1β, KC-GRO, IL-2 and neurodegenerative marker neurofilament light chain (NfL).

-901显著降低了炎症生物标志物IFN-γ、TNF-α、IL-1β、KC-GRO、IL-2和神经退行性标志物神经丝轻链(NfL)。

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-901 significantly reduced inflammasome activation and multiple pro-inflammatory cytokines, including NLRP3, IL-1β, IL-6, IL-2 and KC-GRO in an LPS induced neuroinflammation model, demonstrated anti-inflammatory effects independent of amyloid-beta or tau pathology.

-901显著减少了炎症小体的激活和多种促炎细胞因子,包括NLRP3、IL-1β、IL-6、IL-2和KC-GRO,在LPS诱导的神经炎症模型中表现出独立于淀粉样蛋白-beta或tau病理的抗炎作用。

Progress Across Additional Mechanisms Within Alzheimer's Pathology

阿尔茨海默病病理学中其他机制的进展

Neuroprotection:

神经保护:

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-901 significantly reduces amyloid beta-induced cell death.​

-901显著减少淀粉样蛋白β诱导的细胞死亡。

Neuronal Regeneration:

神经元再生:

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-901 promotes neurite outgrowth, indicating its ability to enhance neuronal connectivity and function.​

-901 促进神经突生长,表明其增强神经元连接和功能的能力。

Behavioral Improvements:

行为改进:

In preclinical studies,

在临床前研究中,

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-901 demonstrates positive trends in cognitive function, anxiety-related behavior, and sensory responsiveness​.

-901在认知功能、焦虑相关行为和感官反应方面表现出积极趋势。

Bioavailability:

生物利用度:

In large animal model,

在大型动物模型中,

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-901 oral formulation achieved anticipated therapeutic levels of systemic exposure​.

-901口服制剂达到了预期的全身暴露治疗水平。

Molecular Validation:

分子验证:

mRNA data aligns with behavioral findings, supporting observed improvements in cognition, memory and neurogenesis.

mRNA数据与行为学结果一致,支持观察到的认知、记忆和神经发生的改善。

Additional Drug Development Progression

额外的药物开发进展

Initiation of the dose-ranging and exposure assessments supporting advancement toward IND-enabling studies.

开始进行支持推进至IND启用研究的剂量范围和暴露评估。

Progress in drug substance and drug product development, including formulation development and scale up to support dose ranging and future GLP studies.

药物物质和药物产品开发的进展,包括配方开发和放大以支持剂量范围确定和未来的GLP研究。

Advancement of drug product and drug substance analytical methods and stability assessments consistent with regulatory expectations.

推进与监管期望一致的药物产品和药物物质分析方法及稳定性评估。

Initiation of a regulatory and clinical development framework to support first-in-human evaluation.

启动支持首次人体评估的监管和临床开发框架。

2026 Development Priorities for

2026年发展重点

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-901 include:

-901 包括:

Conduct a pre-IND meeting with the U.S. Food and Drug Administration in Q3/2026.

在2026年第三季度与美国食品药品监督管理局进行临床前新药(pre-IND)会议。

Continue to execute on IND-enabling pharmacology and toxicology studies.

继续开展IND所需的药理学和毒理学研究。

Continued development and scale up of drug substance and product manufacturing activities to support IND enabling studies and submission.

继续开发和扩大药物物质和产品生产活动,以支持IND相关研究和提交。

Engage regulatory / clinical experts to map out topline clinical design for first in human clinical trials for the

聘请监管/临床专家,为首次人体临床试验制定顶级临床设计。

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-901.

-901。

Subject to regulatory feedback and completion of IND-enabling activities, the Company targets submission of an IND and initiation of a Phase 1 clinical trial in 2027.

根据监管反馈和完成IND所需活动的情况,公司目标是在2027年提交IND并启动一期临床试验。

As we move forward, the progress achieved to date reinforces our confidence in

随着我们向前迈进,迄今为止取得的进展增强了我们的信心

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-901 and in our strategic direction with a disciplined focus on neuroinflammation with a clear development plan. We believe we are positioned to advance

-901,并通过以神经炎症为重点的明确开发计划来确定我们的战略方向。我们相信我们有能力推进

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-901 efficiently and deliver meaningful long-term value for shareholders.

-901高效地为股东提供有意义的长期价值。

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-089 Program Outlook

-089 计划展望

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-089 is a small molecule drug candidate being studied for its potential as a treatment for dry age-related macular degeneration.

-089是一种小分子药物候选物,正在研究其作为治疗干性年龄相关性黄斑变性潜在药物的可能性。

Scientific and development progress and plans include:

科学和发展进展及计划包括:

Generation of data supporting continued evaluation of therapeutic potential.

支持对治疗潜力进行持续评估的数据生成。

Completion of preclinical studies, including dose-ranging assessment, demonstrating dose proportionality and pharmacologically relevant concentration following dosing.

完成包括剂量范围评估在内的临床前研究,证明给药后剂量比例性和药理学相关浓度。

Drug substance and drug product process in place to support IND enabling studies, with further optimization expected in advance of IND submission.

已建立支持IND启用研究的药物物质和药物产品工艺,预计在IND提交之前会进一步优化。

Planning for a pre-IND meeting with the FDA in Q4 2026.

计划在2026年第四季度与FDA举行pre-IND会议。

About InMed:

关于InMed:

InMed Pharmaceuticals

InMed制药公司

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. For more information, visit

是一家制药公司,专注于开发针对 CB1/CB2 受体的专有小分子药物候选管线。InMed 的管线包括三个独立的项目,分别用于治疗阿尔茨海默病、眼部和皮肤病适应症。欲了解更多信息,请访问

www.inmedpharma.com

www.inmedpharma.com

.

Investor Contact:

投资者联系人:

Colin Clancy

科林·克兰西

Vice President, Investor Relations

投资者关系副总裁

and Corporate Communications

公司传播部门

T: +1.604.416.0999

电话:+1.604.416.0999

E:

E:

ir@inmedpharma.com

ir@inmedpharma.com

Cautionary Note Regarding Forward-Looking Information:

关于前瞻性信息的谨慎声明:

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.

本新闻稿包含适用证券法意义上的“前瞻性信息”和“前瞻性陈述”(统称为“前瞻性信息”)。前瞻性陈述经常但并非总是通过诸如“预期”、“预计”、“相信”、“打算”、“潜力”、“可能”、“将会”等词语及类似表述加以识别。

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.

这些声明基于管理层的当前预期,本质上涉及众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的当前预期和信念,并受多种风险和不确定性的影响,可能导致实际结果与前瞻性声明中描述的内容存在重大差异。

Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: developing a pipeline of disease-modifying small molecule drug candidates that target CB1/CB2 receptors; the potential efficacy of .

本新闻稿中的前瞻性信息包括但不限于以下陈述:开发针对CB1/CB2受体的疾病修饰小分子药物候选管线;其潜在疗效。

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-901;

-901;

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-901's ability to treat Alzheimer's; marketability and uses for

-901治疗阿尔茨海默病的能力;市场推广及用途

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-901; the advancement of chemistry, manufacturing, and controls (CMC) activities; the planning of GLP-enabling studies and the preparation of an IND submission the further development; planning for a pre-IND meeting in Q3 2026; engaging regulatory / clinical experts to map out topline clinical design for first in human clinical trials for the .

-901;化学、制造和控制(CMC)活动的进展;GLP支持研究的规划以及IND提交的进一步开发;2026年第三季度召开pre-IND会议的计划;聘请监管/临床专家,为首次人体临床试验设计出大致的临床方案。

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-901; targeting submission of an IND and initiation of a Phase 1 clinical trial in 2027; potential efficacy, and marketability of

-901;目标是在2027年提交IND并启动一期临床试验;潜在的疗效及市场推广可能性

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-089 for dry age-related macular degeneration; preparing for a pre-IND meeting with the FDA in Q4 2026 for

-089用于干性年龄相关性黄斑变性;准备在2026年第四季度与FDA举行pre-IND会议

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-089.

-089。

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 business is disclosed in InMed's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on .

此外,存在已知和未知的风险因素,这些因素可能导致InMed的实际结果、业绩或成就与本文所含前瞻性信息中明示或暗示的任何未来结果、业绩或成就有重大差异。关于InMed业务所面临的全部风险和不确定性的完整讨论,已在InMed的年度报告Form 10-K及其他向证券交易委员会提交的文件中披露。

www.sec.gov

www.sec.gov

.

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..

本谨慎声明完全适用于本文中的所有前瞻性信息,InMed公司不承担任何修订或更新任何此类前瞻性信息的义务,也不承担公开宣布对本文中包含的任何前瞻性信息进行修订的结果以反映未来结果、事件或发展的义务,除非法律要求。

To view the source version of this press release, please visit

要查看此新闻稿的源版本,请访问

https://www.newsfilecorp.com/release/287694

https://www.newsfilecorp.com/release/287694

News Provided by TMX Newsfile via QuoteMedia

由TMX Newsfile通过QuoteMedia提供的新闻

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