Mira Pharmaceuticals Announces Positive Preclinical Study Results For Its Novel Oral ketamine Analog, Ketamir-2, Paving the Way for IND Submission Later This Year
MIRA Pharmaceuticals announced positive preclinical results for Ketamir-2, an oral ketamine analog, suggesting it as a potential superior alternative to traditional ketamine for treating depression and treatment-resistant depression (TRD). The study conducted by Pharmaseed revealed that Ketamir-2 showed higher efficacy and safety compared to oral ketamine in male mice, with significant improvements in locomotor activity, reduced anxiety, and antidepressant effects. Unlike ketamine, Ketamir-2 can be administered orally, promising better patient compliance and is not a controlled substance under DEA rules. MIRA plans to submit an Investigational New Drug Application (IND) to the FDA later this year to initiate human trials.
- Positive preclinical results for Ketamir-2 as a treatment for depression and TRD.
- Ketamir-2 showed higher efficacy and better safety profile vs. oral ketamine in preclinical trials.
- Ketamir-2 can be administered orally, unlike traditional ketamine.
- Not a controlled substance under DEA rules.
- Significant milestones achieved for IND submission to the FDA later this year.
- Potential for better patient compliance due to oral formulation.
- Results are to preclinical trials in male mice.
- No human clinical trial data available yet.
- Potential regulatory hurdles in the IND submission process.
- Efficacy and safety in humans are still unproven.
Insights
The preclinical study results for Ketamir-2 are promising, showcasing the drug's potential as a novel treatment for depression and treatment-resistant depression (TRD). Ketamir-2, an oral ketamine analog, demonstrates effective antidepressant properties while maintaining a better safety profile compared to traditional ketamine. Unlike ketamine, which can have sedative and other side effects, Ketamir-2 allows for higher dosing without these issues, enhancing patient compliance and safety.
For investors, the key takeaway is the drug's compelling therapeutic potential, particularly given its non-controlled substance status. The shift from intravenous or intranasal administration to an oral formulation could significantly broaden its market acceptance and patient adherence. The upcoming IND submission to the FDA marks a critical step, as approval could lead to human clinical trials—an essential milestone for validating these preclinical findings.
While the results are encouraging, it's important to note that these are preclinical findings. Human trials could present different outcomes. Investors should monitor the progression to clinical trials, as success there would substantially bolster the company's prospects and potentially its stock value. However, there's inherent risk until more definitive human data is available.
From a financial perspective, the positive preclinical results for Ketamir-2 are a significant development for Mira Pharmaceuticals. If Ketamir-2 can transition successfully through clinical trials, it has the potential to capture a significant share of the depression and TRD treatment markets. Depression affects millions globally and a new, effective oral treatment could see widespread adoption.
Currently, Mira Pharmaceuticals is a pre-clinical-stage company, which implies inherent risks associated with early-stage biotechs. The upcoming IND submission is a pivotal event—successful acceptance could act as a major catalyst for the stock. Additionally, the company's ability to secure partnerships or funding to support clinical trials will be crucial. Investors should assess the company's cash runway and funding strategy, as extensive clinical trials can be costly.
Given the encouraging data and the potential market for a new depression treatment, Mira Pharmaceuticals presents a high-risk but high-reward opportunity. The next milestones to watch are the IND submission and subsequent FDA feedback, which will provide more clarity on the drug's path forward.
The positive results from this preclinical study underscore Ketamir-2's potential as a superior alternative to traditional ketamine
Unlike ketamine, which requires intravenous or intranasal administration, Ketamir-2's oral formulation promises ease of use and better patient compliance and is not a controlled substance under DEA rules
The highly encouraging study results further MIRA's goal of submitting an Investigational New Drug Application (IND) to the
Key Findings from the Study
The study, conducted by Pharmaseed Ltd., evaluated the anti-depressive and anxiolytic effects of oral Ketamir-2, in comparison with oral ketamine, using established behavioral tests in male mice. The tests included the Open Field Test (OFT), Elevated Plus Maze (EPM), and Forced Swim Test (FST). Under the experimental conditions of these studies, it was possible to use 10 fold-higher oral doses of Ketamir-2, compared with ketamine, which induced major sedative and other side effects already at low doses.
The following findings were observed:
- Open Field Test (OFT)
- Mice treated with Ketamir-2 showed dose-related, significantly greater locomotor activity, higher travel speed and a trend towards an increased time spent in the center of the arena, indicating reduced anxiety levels.
- Elevated Plus Maze (EPM)
- In this model of depression, significant increases in travel distance and speed were observed in mice treated with Ketamir-2. Furthermore, Ketamir-2 treated mice spent more time in the open arms of the maze, suggesting reduced anxiety.
- Forced Swim Test (FST)
- In this model of depression and anxiety, mice in the Ketamir-2 treated arm demonstrated reduced swimming distances and speed, indicating reduced behavioral despair and anti-depressant effect.
- In addition, Ketamir-2 treatment resulted in significantly reduced immobility times, highlighting its potential antidepressant properties.
Traditional ketamine was used as a positive control in this study. In many of the above parameters, traditional ketamine given orally at the highest dose feasible was inactive, again pointing to the comparative potential benefits of Ketamir-2, which is designed to be delivered orally.
Clinical Implications and Future Directions
The positive results from this preclinical study underscore Ketamir-2's potential as a superior alternative to traditional ketamine. Ongoing studies with third-party research organizations Pharmaseed and Biotrial are evaluating Ketamir-2's efficacy in treating post-traumatic stress syndrome and neuropathic pain, as well as conducting further safety studies in comparison to ketamine.
"We are thrilled with the promising results from these preclinical trials, which demonstrate Ketamir-2's efficacy and improved safety profile over traditional ketamine," said Erez Aminov, Chairman & CEO of Mira Pharmaceuticals. "These findings represent a significant milestone as we prepare for an IND submission to the FDA later this year. We are hopeful that Ketamir-2 will offer a new, safe and orally effective treatment option for patients suffering from depression and TRD."
Dr. Itzchak Angel, Chief Scientific Advisor of Mira Pharmaceuticals, added, "The data generated from these studies will be invaluable in demonstrating Ketamir-2's potential benefits. Its demonstrated activity by the oral route, its pharmacological profile and lack of unwanted side-effects make Ketamir-2 a potentially safer and more effective option for treating depression in a home setting."
About MIRA Pharmaceuticals
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
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. The
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.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of the Company's management related thereto 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 that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release 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 and adversely 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 additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
View original content:SOURCE MIRA Pharmaceuticals, Inc.
FAQ
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