MIRA Pharmaceuticals Announces Ketamir-2 Shows Promising Safety Profile in Comparison to Traditional Ketamine In Preclinical Testing

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ: MIRA) has announced promising preclinical results for its oral ketamine analog, Ketamir-2, showing it does not induce hyper-locomotor activity, a psychotic symptom common with traditional ketamine use.

This indicates Ketamir-2 could offer safer mental health treatments. Conducted with Biotrial, the study evaluated Ketamir-2's effects on spontaneous locomotor activity in mice. Unlike traditional ketamine, Ketamir-2 did not trigger hyperlocomotion, suggesting reduced risks of psychotic behaviors and misuse.

MIRA plans to submit an IND application to the FDA by year-end. This development positions Ketamir-2 for broader psychiatric and neurologic applications, potentially reducing healthcare costs for conditions like treatment-resistant depression, which currently costs the U.S. $43.8 billion annually.

Further studies on Ketamir-2's safety and efficacy are ongoing, with potential applications for cancer pain and PTSD.

Positive

• Ketamir-2 shows no hyper-locomotor activity, unlike traditional ketamine.
• Potential for safer mental health treatments with fewer psychotic symptoms.
• Broad therapeutic applications in psychiatric and neurologic conditions.
• Could reduce healthcare costs for treatment-resistant depression.
• IND application to FDA planned by end of the year.

Negative

• Preclinical results only; clinical efficacy and safety not yet proven.
• Further studies required to confirm findings and potential applications.

Medical Research Analyst

The recent preclinical results for Ketamir-2, MIRA Pharmaceuticals' novel oral ketamine analog, show promising potential. Key findings indicate that Ketamir-2 does not induce hyper-locomotor activity, a side effect often linked with traditional ketamine, which can mimic psychotic symptoms. By avoiding this issue, Ketamir-2 represents a safer alternative for treating mental health disorders such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).

Therapeutic implications include broader applications in psychiatry and neurology, as Ketamir-2's safety profile could make it suitable for a wider patient population. This is particularly important for long-term treatment adherence and efficacy. Additionally, the absence of hyper-locomotor activity could reduce the risk of misuse, further enhancing patient safety.

From a research perspective, the results suggest MIRA is on the right track with its IND submission to the FDA, which might pave the way for clinical trials and eventual market approval. These advancements position Ketamir-2 as a potential game-changer in mental health therapeutics.

Financial Analyst

From a financial standpoint, the development of Ketamir-2 could significantly impact MIRA Pharmaceuticals' market value. The estimated $43.8 billion annual cost of treatment-resistant depression in the U.S. alone highlights the economic potential of an effective and safer alternative to traditional ketamine. If Ketamir-2 reaches the market, it could capture a substantial share, driving revenue growth for MIRA.

Short-term impacts include potential stock gains driven by investor optimism around the positive preclinical data and the anticipated FDA IND submission. However, long-term financial success will depend on subsequent clinical trial results and eventual market approval. Investors should monitor these milestones closely.

While the preliminary data is promising, investors should remain cautious about the inherent uncertainties in drug development, including potential regulatory hurdles and clinical trial outcomes. Still, MIRA's focus on addressing significant gaps in mental health treatment positions the company advantageously in a high-demand market.

Market Research Analyst

Market dynamics indicate a growing demand for safer and more effective mental health treatments. Traditional ketamine, while efficacious, carries significant risks, including hyper-locomotion and potential misuse. Ketamir-2's safety profile addresses these concerns, positioning it as a strong competitor in the pharmaceutical market for mental health therapies.

Broader market implications include potential applications in neuropathic pain management and other psychiatric disorders. If Ketamir-2 can demonstrate similar efficacy in these areas without the associated risks of traditional ketamine, it could lead to expanded market opportunities and increased adoption by healthcare providers.

Moreover, the push for more patient-friendly treatments aligns with current trends in healthcare, where safety and tolerability are becoming increasingly important. MIRA's proactive approach in conducting further safety and efficacy studies ahead of the IND submission will likely boost confidence among stakeholders and healthcare professionals.

New preclinical studies suggest that, unlike traditional ketamine, MIRA's oral ketamine analog Ketamir-2 does not induce hyper-locomotor activity, indicative of psychotic symptoms, offering the potential for safer mental health treatments

MIAMI, June 24, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today announced new compelling preclinical results for its investigational compound, Ketamir-2, a novel oral ketamine analog. The new data highlights Ketamir's potential to provide therapeutic benefits without inducing schizophrenia-like behavior or hyper-locomotor activity. 

These results follow the release of positive preclinical efficacy data for Ketamir-2 earlier in June, which collectively are forming the basis of an Investigational New Drug Application (IND) that MIRA plans to submit to the U.S. Food and Drug Administration (FDA) for Ketamir-2 by the end of this year.

Background on the Current Preclinical Study

MIRA conducted the latest rigorous preclinical studies in collaboration with Biotrial to evaluate the effects of Ketamir-2 on spontaneous locomotor activity in mice. The studies are particularly significant for the treatment of mental health disorders and pain management, presenting a major advancement in the development of safer and more effective therapeutic options.

Ketamine-induced hyperlocomotion is considered a schizophrenia-like effect because it models the hyperactive and psychotic symptoms observed in schizophrenia patients. The hyperlocomotion induced by traditional ketamine is mediated by increased dopamine release and turnover in the nucleus accumbens, a brain region implicated in the positive symptoms of schizophrenia, such as psychosis.  Antipsychotic drugs like haloperidol, which block dopamine receptors, can reduce the effect of ketamine-induced hyperlocomotion, further linking this behavior to the dopaminergic dysregulation hypothesized in schizophrenia.

Key Findings from the Study:

1. Reduced Psychotic-like Symptoms: Unlike traditional ketamine, which resulted in marked and significant hyperlocomotion, Ketamir-2 did not produce incidences of inducing hyperlocomotion, schizophrenia-like behaviors in animal models, indicating a potentially safer profile for human patients, especially those with a predisposition to psychotic disorders.
2. No Hyper-locomotor Activity: The study showed that while traditional ketamine induced hyperlocomotion, Ketamir-2, at same and higher doses compared with traditional ketamine, did not result in the hyper-locomotor activity, reducing the potential for misuse and enhancing patient safety.

Implications for Patient Care and Market Potential:

Safety and Tolerability: By mitigating adverse effects commonly linked with traditional ketamine, Ketamir-2 potentially represents a significant leap forward in developing effective and patient-friendly treatments for certain mental health disorders and neuropathic pain.  This improvement is crucial for long-term patient compliance and overall treatment success.

Broader Therapeutic Applications: Ketamir-2's different profile with enhanced safety features allows for its potential use in a wider range of psychiatric and neurologic conditions, expanding its applicability beyond current ketamine treatments.  This potentially positions Ketamir-2 as a versatile option in the pharmaceutical landscape.

Economic Impact: With the financial burden of treatment-resistant depression alone accounting for $43.8 billion annually in the U.S., Ketamir-2's development could lead to substantial cost savings in healthcare by providing a more efficient and safer treatment alternative.

Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals, stated, "Our latest findings on Ketamir-2 reinforce our commitment to addressing critical gaps in mental health treatment. By offering a safer and more effective oral alternative to traditional ketamine, we are paving the way for groundbreaking advancements in patient care and treatment outcomes."

Next Steps:

MIRA is on track to submit an IND application for Ketamir-2 to the FDA by the end of this year. This submission will mark a significant milestone in advancing Ketamir-2 toward clinical trials and eventually making it available to patients in need.  Additionally, MIRA is conducting further safety and efficacy studies on Ketamir-2 to further demonstrate its improved profile compared to traditional ketamine.  MIRA's commitment to advancing research includes further studies on Ketamir-2 for cancer pain and PTSD, aiming to provide effective and safe treatment options for these challenging conditions.

Itzchak Angel, Ph.D., MIRA's Chief Scientific Advisor, added, "The data we have obtained from these studies is invaluable. They not only enhance our understanding of Ketamir-2's pharmacological profile but also underscore its potential benefits for patients with TRD and PTSD and pave the way for what we believe will be straightforward IND-enabling development."

About MIRA Pharmaceuticals, Inc.

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.

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 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 commercialization of these drug candidates.

For more information, visit www.mirapharmaceuticals.com.

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 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, Ketamir's potential in treating certain mental health conditions, and the timing for further preclinical and clinical studies and FDA submissions. 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 www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except as required by law.

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SOURCE MIRA Pharmaceuticals, Inc.

FAQ

What are the key findings of MIRA Pharmaceuticals' Ketamir-2 preclinical studies?

The studies showed that Ketamir-2 did not induce hyper-locomotor activity or schizophrenia-like behaviors, unlike traditional ketamine, suggesting a safer profile for mental health treatments.

When does MIRA Pharmaceuticals plan to submit the IND application for Ketamir-2?

MIRA plans to submit the IND application to the FDA by the end of this year.

How does Ketamir-2 compare to traditional ketamine?

Ketamir-2 did not induce hyper-locomotor activity, which is a psychotic symptom associated with traditional ketamine, indicating a potentially safer treatment option.

What are the potential economic impacts of Ketamir-2?

Ketamir-2 could reduce healthcare costs associated with treatment-resistant depression, which currently totals $43.8 billion annually in the U.S.

What further studies are being conducted on Ketamir-2?

MIRA is conducting additional safety and efficacy studies on Ketamir-2, including potential applications for cancer pain and PTSD.