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
測試證實MIRA對神經和神經精神障礙的潛在治療方法的初步信念
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。(納斯達克:MIRA)(“MIRA”或“公司”)是一家臨床前期製藥開發公司,今天宣佈其新型口服藥物大麻類似物MIRA-55的最新臨床前研究結果顯示了可喜的新發現,該類似物正作爲治療焦慮和認知下降的潛在治療方法進行研究。
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.
新數據證實了MIRA早期對MIRA-55藥物的藥理特性和潛在效力的信念。然而,有意義的是,新的臨床前數據直接將MIRA-55與大麻的主要精神活性成分THC進行了比較,並顯示了可喜的結果。
Background on MIRA1a and Discovery of MIRA-55
MIRA1a和MIRA-55的背景和發現
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最初將其大麻類似物臨床前研究計劃聚焦於一種名爲“MIRA1a”的口服化合物。正如2024年3月披露的那樣,2023年末,MIRA基於與其代工廠商的討論開始懷疑MIRA1a實際上是一種具有獨特化學結構的新分子,MIRA將其命名爲“MIRA-55”。這一發現促使MIRA於2024年3月提交了關於MIRA-55的全球臨時專利申請。當時,MIRA表示其相信MIRA-55在勢力和潛在效力方面表現出優異的表現,但需要進行附加的測試來證實MIRA的初步信念。今天宣佈的新測試結果提供了這樣的證實。
Recent Findings on MIRA-55
關於MIRA-55的最新研究發現
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.
最近的臨床前研究在體內和小鼠模型中進行,證實MIRA-55相較於THC具有顯著的潛在優勢。MIRA-55顯示出較高的CB1和CB2大麻素受體的療效。隨着濃度的增加,它還顯示出更加明顯和持久的激動作用增加,表明對於激活其治療效果的關鍵大麻素受體的可能性更大。這些結果證實了MIRA的信念,即MIRA-55可能爲焦慮和認知下降等病症提供更強大和可靠的緩解。
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受體上保持一種新的平衡,這可能支持其在更廣泛劑量範圍內的有效性。與THC不同,後者在更高劑量下往往會失去其效力,這些結果表明MIRA-55似乎隨着劑量的增加而保持強大作用。這種持續的活性意味着MIRA-55可以提供更一致和長效的治療益處,使它成爲更有前途的目標指示候選。
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.
在探索其潛在抗焦慮特性的研究中,MIRA-55顯示出一致的、劑量依賴性的抗類焦慮行爲減少。在開放場測試和高架十字迷宮測試中,MIRA-55表現出比THC更可預測和更強的抗焦慮效果。MIRA-55增加了測試對象在場地中央和迷宮開放臂停留的時間,表明焦慮減少。THC雖然有效,但結果更加不確定和較少一致。
Summary of Results: MIRA-55 vs. THC
結果概要:MIRA-55 vs. THC
The recent studies showed the following:
最近的研究結果如下:
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.
提高療效:MIRA-55在CB1和CB2大麻素受體方面顯示出比THC更顯著的療效,在活性方面表現出更強烈和更持久的表現。
穩定的抗焦慮效果:MIRA-55在開放場測試和高架十字迷宮測試中一致地減少了焦慮樣行爲,表現出比THC更可預測和更強的抗焦慮效果。
穩定與平衡:與THC不同,MIRA-55在更廣泛的劑量範圍內保持有效性而無需失去效果。
降低副作用:MIRA-55表現出一種更具有應用前景的毒理學特性,表明它是人類治療的潛在更安全的產品。
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董事長兼CEO Erez Aminov補充道:“我們非常興奮地看到這些結果,以及對MIRA-55在製藥行業中潛在影響的確認。我們致力於開發創新療法,不斷推動我們的研究和開發工作。我們將進行更多的臨床前研究,以進一步接近MIRA-55的新藥申請(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的首席科學顧問Itzchak Angel博士評論道:“與早些時候展示良好毒理學特性的研究一起,這些發現突出顯示了MIRA-55具有顯著不同的藥理特性。這種藥理特性可能轉化爲具有更好治療潛力的有效治療選項,減少了與THC有關的毒性和副作用。
About MIRA Pharmaceuticals, Inc.
關於MIRA藥品公司。
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.(納斯達克:MIRA)是一家臨床前製藥開發公司,擁有兩個針對廣泛範圍的神經和神經精神障礙的神經科學項目。MIRA持有Ketamir-2的獨家美國、加拿大和墨西哥權利,這是一種新型的、專利待定的口服氯胺酮類似物,正在研究中,可能提供超快速抗抑鬱效果,爲抗治療抵抗性抑鬱症、帶有自殺傾向的重度抑鬱症以及創傷後應激障礙的患者提供希望。
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的新型口服藥用大麻類似物MIRA-55目前正在研究中,用於治療神經痛以及與早期癡呆症常見的焦慮和認知下降症狀。如果FDA批准,MIRA-55可能是解決各種神經精神、炎症和神經系統疾病和障礙的重要進展。
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.
美國藥物執法局對Ketamir-2和MIRA-55的科學審查得出結論,不會將它們視爲受控物質或列出的化學品,在《受控物質法》及其管理規定下不屬於控制物質或列出的化學品。這些結論消除了這些藥物候選者的製造、臨床前開發、IND提交、臨床開發和最終商業化中可能出現的潛在複雜性。
For more information, visit .
欲了解更多信息,請訪問網站。
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處於臨床前階段的研發中。無法保證這些產品將通過研發或獲得FDA批准銷售。
Cautionary Note Regarding Forward-Looking Statements
關於前瞻性聲明的謹慎說明
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.
本新聞稿包含"前瞻性陳述",這些陳述不是根據1933年證券法修正案第27A條和1934年證券交易法修正案第21E條的安全港規定製定的歷史事實陳述,可通過"旨在"、"預計"、"相信"、"可能"、"估計"、"預計"、"預測"、"目標"、"意向"、"可能"、"計劃"、"潛在"、"可能尋求"、"將"和類似用語或表達方式來確定。本新聞稿中的任何不是歷史事實的陳述均可能被視爲前瞻性陳述。這些前瞻性陳述包括但不限於關於所述研究結果的潛在益處、MIRA-55在治療某些心理健康狀況方面的潛力及與MIRA-55相關的進一步臨床前和臨床研究以及FDA提交的時間等。前瞻性陳述僅基於本公司當前的期望、估計和投射,僅截至本發佈日,受到一系列風險和不確定性(其中許多超出本公司的控制),可能導致實際結果與此類前瞻性陳述所設定的結果大相徑庭。有關本公司計劃和業務的這些和其他風險詳細介紹於2023年12月31日年度報告的10-k表格和其他SEC提交中,可以在www.sec.gov和本公司網站上獲得。本公司明確聲明除非法律要求否則不承擔任何更新前瞻性陳述的義務。
Contact;
聯繫方式;
Office: 813.505.0282
Email: myanez@mirapharma.com
辦公室:813.505.0282
電子郵件:myanez@mirapharma.com
SOURCE: MIRA Pharmaceuticals, Inc.
來源:MIRA藥品公司。