Mira Pharmaceuticals Announces Promising Results for MIRA-55 in Multiple Preclinical Tests Compared to THC
Mira Pharmaceuticals Announces Promising Results for MIRA-55 in Multiple Preclinical Tests Compared to THC
Testing confirms MIRA's preliminary beliefs regarding potential treatment for neurological and neuropsychiatric disorders
测试证实MIRA对神经和神经精神障碍的潜在治疗方法的初步信念
MIAMI, FL / ACCESSWIRE / July 15, 2024 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical development company, today announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being studied as a potential treatment for anxiety and cognitive decline.
FL MIAMI / ACCESSWIRE / 2024年7月15日 / MIRA Pharmaceuticals,Inc。(纳斯达克:MIRA)(“MIRA”或“公司”)是一家临床前期制药开发公司,今天宣布其新型口服药物大麻类似物MIRA-55的最新临床前研究结果显示了可喜的新发现,该类似物正作为治疗焦虑和认知下降的潜在治疗方法进行研究。
The new data confirms MIRA's earlier beliefs regarding MIRA-55's pharmacological profile and potential for potency and efficacy. Importantly, however, the new preclinical data compared MIRA-55 directly to THC, the main psychoactive component in marijuana, and showed promising results.
新数据证实了MIRA早期对MIRA-55药物的药理特性和潜在效力的信念。然而,有意义的是,新的临床前数据直接将MIRA-55与大麻的主要精神活性成分THC进行了比较,并显示了可喜的结果。
Background on MIRA1a and Discovery of MIRA-55
MIRA1a和MIRA-55的背景和发现
MIRA initially focused its marijuana analog preclinical study program around an oral compound called "MIRA1a." As previously disclosed in March 2024, in late 2023, MIRA, based on discussions with its contract manufacturers, began to suspect that MIRA1a was in fact a new molecule with a distinct chemical structure, which MIRA named "MIRA-55". This discovery led to the filing by MIRA of a global provisional patent application for MIRA-55 in March 2024. At that time, MIRA indicated its belief that MIRA-55 displayed enhanced potency and potential for efficacy over MIRA1a but noted that additional testing was required to confirm MIRA's preliminary beliefs. The new testing results announced today provide such confirmation.
MIRA最初将其大麻类似物临床前研究计划聚焦于一种名为“MIRA1a”的口服化合物。正如2024年3月披露的那样,2023年末,MIRA基于与其代工厂商的讨论开始怀疑MIRA1a实际上是一种具有独特化学结构的新分子,MIRA将其命名为“MIRA-55”。这一发现促使MIRA于2024年3月提交了关于MIRA-55的全球临时专利申请。当时,MIRA表示其相信MIRA-55在势力和潜在效力方面表现出优异的表现,但需要进行附加的测试来证实MIRA的初步信念。今天宣布的新测试结果提供了这样的证实。
Recent Findings on MIRA-55
关于MIRA-55的最新研究发现
The recent preclinical studies, conducted in vitro and through a mouse model, confirm that MIRA-55 offers significant potential advantages over THC. MIRA-55 showed higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC. It also demonstrated a more pronounced and sustained increase in agonist activity as the concentration increases, indicating the potential for greater effectiveness in activating key cannabinoid receptors responsible for its therapeutic effects. These results confirmed MIRA's belief that MIRA-55 could potentially provide stronger and more reliable relief for conditions like anxiety and cognitive decline.
最近的临床前研究在体内和小鼠模型中进行,证实MIRA-55相较于THC具有显著的潜在优势。MIRA-55显示出较高的CB1和CB2大麻素受体的疗效。随着浓度的增加,它还显示出更加明显和持久的激动作用增加,表明对于激活其治疗效果的关键大麻素受体的可能性更大。这些结果证实了MIRA的信念,即MIRA-55可能为焦虑和认知下降等病症提供更强大和可靠的缓解。
Additionally, MIRA-55 appears to maintain a novel balance between its activity on the CB1 and CB2 receptors, which may support its effectiveness over a broader range of doses. Unlike THC, which tends to lose its effectiveness at higher doses, these results demonstrate that MIRA-55 appears to maintain robust efficacy as doses increase. This sustained activity means that MIRA-55 could provide more consistent and prolonged therapeutic benefits, making it a more promising candidate for its target indications.
此外,MIRA-55似乎在CB1和CB2受体上保持一种新的平衡,这可能支持其在更广泛剂量范围内的有效性。与THC不同,后者在更高剂量下往往会失去其效力,这些结果表明MIRA-55似乎随着剂量的增加而保持强大作用。这种持续的活性意味着MIRA-55可以提供更一致和长效的治疗益处,使它成为更有前途的目标指示候选。
In studies exploring its potential anxiolytic properties, MIRA-55 showed a consistent, dose-dependent reduction in anxiety-like behaviors. In the Open Field Test and Elevated Plus Maze Test, MIRA-55 demonstrated a more predictable and stronger anxiolytic effect compared to THC. MIRA-55 increased the time spent by testing subjects in the center of the field and open arms of the maze, suggesting reduced anxiety. THC, while effective, showed more variable and less consistent results.
在探索其潜在抗焦虑特性的研究中,MIRA-55显示出一致的、剂量依赖性的抗类焦虑行为减少。在开放场测试和高架十字迷宫测试中,MIRA-55表现出比THC更可预测和更强的抗焦虑效果。MIRA-55增加了测试对象在场地中央和迷宫开放臂停留的时间,表明焦虑减少。THC虽然有效,但结果更加不确定和较少一致。
Summary of Results: MIRA-55 vs. THC
结果概要:MIRA-55 vs. THC
The recent studies showed the following:
最近的研究结果如下:
Enhanced Efficacy: MIRA-55 showed significantly improved efficacy over THC at both the CB1 and CB2 cannabinoid receptors, with stronger and more sustained activity.
Consistent Anxiolytic Effects: MIRA-55 consistently reduced anxiety-like behaviors, outperforming THC in the Open Field and Elevated Plus Maze tests.
Stability and Balance: Unlike THC, MIRA-55 maintained efficacy across a broader range of doses without losing effectiveness.
Reduced Side Effects: MIRA-55 demonstrated a promising toxicological profile, indicating a potential safer profile for human therapeutic use.
提高疗效:MIRA-55在CB1和CB2大麻素受体方面显示出比THC更显著的疗效,在活性方面表现出更强烈和更持久的表现。
稳定的抗焦虑效果:MIRA-55在开放场测试和高架十字迷宫测试中一致地减少了焦虑样行为,表现出比THC更可预测和更强的抗焦虑效果。
稳定与平衡:与THC不同,MIRA-55在更广泛的剂量范围内保持有效性而无需失去效果。
降低副作用:MIRA-55表现出一种更具有应用前景的毒理学特性,表明它是人类治疗的潜在更安全的产品。
Erez Aminov, CEO and Chairman of MIRA Pharmaceuticals, added, "We are thrilled with these results and the confirmation of our earlier beliefs regarding the potential impact of MIRA-55 in the pharmaceutical industry. Our dedication to developing innovative treatments continues to drive our research and development efforts. We will be conducting additional preclinical studies to advance us closer to an Investigational New Drug (IND) application for MIRA-55."
MIRA Pharmaceuticals董事长兼CEO Erez Aminov补充道:“我们非常兴奋地看到这些结果,以及对MIRA-55在制药行业中潜在影响的确认。我们致力于开发创新疗法,不断推动我们的研究和开发工作。我们将进行更多的临床前研究,以进一步接近MIRA-55的新药申请(IND)。”
Dr. Itzchak Angel, Chief Scientific Advisor to MIRA Pharmaceuticals, commented, "Together with earlier studies showing a good toxicology profile, these findings highlight a significantly differentiated pharmacological profile for MIRA-55. This profile could translate into great therapeutic potential, providing more effective treatment options for patients suffering from neurological and neuropsychiatric disorders with lower toxicities and side effects typically associated with THC."
MIRA Pharmaceuticals的首席科学顾问Itzchak Angel博士评论道:“与早些时候展示良好毒理学特性的研究一起,这些发现突出显示了MIRA-55具有显著不同的药理特性。这种药理特性可能转化为具有更好治疗潜力的有效治疗选项,减少了与THC有关的毒性和副作用。
About MIRA Pharmaceuticals, Inc.
关于MIRA药品公司。
MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation, and post-traumatic stress disorder.
MIRA Pharmaceuticals,Inc.(纳斯达克:MIRA)是一家临床前制药开发公司,拥有两个针对广泛范围的神经和神经精神障碍的神经科学项目。MIRA持有Ketamir-2的独家美国、加拿大和墨西哥权利,这是一种新型的、专利待定的口服氯胺酮类似物,正在研究中,可能提供超快速抗抑郁效果,为抗治疗抵抗性抑郁症、带有自杀倾向的重度抑郁症以及创伤后应激障碍的患者提供希望。
In addition, MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.
此外,MIRA的新型口服药用大麻类似物MIRA-55目前正在研究中,用于治疗神经痛以及与早期痴呆症常见的焦虑和认知下降症状。如果FDA批准,MIRA-55可能是解决各种神经精神、炎症和神经系统疾病和障碍的重要进展。
The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 and MIRA-55 concluded that each would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. These conclusions remove potential complications for manufacturing, pre-clinical development, IND submission, clinical development, and ultimately commercialization of these drug candidates.
美国药物执法局对Ketamir-2和MIRA-55的科学审查得出结论,不会将它们视为受控物质或列出的化学品,在《受控物质法》及其管理规定下不属于控制物质或列出的化学品。这些结论消除了这些药物候选者的制造、临床前开发、IND提交、临床开发和最终商业化中可能出现的潜在复杂性。
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Ketamir-2 and MIRA-55 are in early-stage preclinical development. There is no assurance that the products will proceed through development or will receive FDA approval for marketing.
Ketamir-2和MIRA-55处于临床前阶段的研发中。无法保证这些产品将通过研发或获得FDA批准销售。
Cautionary Note Regarding Forward-Looking Statements
关于前瞻性声明的谨慎说明
This press release contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions. Any statements in this press release that are not historical facts may be deemed forward-looking statements. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein, MIRA-55's potential in treating certain mental health conditions, and the timing for further preclinical and clinical studies and FDA submissions related to MIRA-55. Forward-looking statements are based on the Company's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in detail in the Annual Report on Form 10-K for the year ended December 31, 2023, and other SEC filings, available at www.sec.gov and the Company's website at . The Company explicitly disclaims any obligation to update any forward-looking statements except as required by law.
本新闻稿包含"前瞻性陈述",这些陈述不是根据1933年证券法修正案第27A条和1934年证券交易法修正案第21E条的安全港规定制定的历史事实陈述,可通过"旨在"、"预计"、"相信"、"可能"、"估计"、"预计"、"预测"、"目标"、"意向"、"可能"、"计划"、"潜在"、"可能寻求"、"将"和类似用语或表达方式来确定。本新闻稿中的任何不是历史事实的陈述均可能被视为前瞻性陈述。这些前瞻性陈述包括但不限于关于所述研究结果的潜在益处、MIRA-55在治疗某些心理健康状况方面的潜力及与MIRA-55相关的进一步临床前和临床研究以及FDA提交的时间等。前瞻性陈述仅基于本公司当前的期望、估计和投射,仅截至本发布日,受到一系列风险和不确定性(其中许多超出本公司的控制),可能导致实际结果与此类前瞻性陈述所设定的结果大相径庭。有关本公司计划和业务的这些和其他风险详细介绍于2023年12月31日年度报告的10-k表格和其他SEC提交中,可以在www.sec.gov和本公司网站上获得。本公司明确声明除非法律要求否则不承担任何更新前瞻性陈述的义务。
Contact;
联系方式;
Office: 813.505.0282
Email: myanez@mirapharma.com
办公室:813.505.0282
电子邮件:myanez@mirapharma.com
SOURCE: MIRA Pharmaceuticals, Inc.
来源:MIRA药品公司。