• 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.