Mira Pharmaceuticals Announces Encouraging Preclinical Results Advancing Ketamir-2 Towards Potential Year-End IND Submission

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Ketamir-2 is a potential treatment for certain major mental health disorders impacting millions of people in the U.S.

MIAMI, April 2, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today shares updates on the ongoing pre-clinical studies of its investigational compound, Ketamir-2, a novel oral ketamine analog which could potentially deliver ultra-rapid antidepressant effects. 

MIRA is conducting pre-clinical studies of Ketamir-2 in collaboration with Frontage Laboratories as a potential treatment for individuals battling treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI) and post-traumatic stress disorder (PTSD).  MIRA is hopeful that the encouraging results of these most recent studies will enable MIRA to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration by the end of this year which, if accepted, would allow for human testing of Ketamir-2. 

The latest in vitro research focused on Ketamir-2's stability in the bloodstream, its metabolism (processing by the body), and how it binds to proteins in the blood.  These factors play a crucial role in determining a drug's adequacy and likelihood for acceptable safety, its pharmacological profile and potential modes of administration to patients.

  1. Blood Stability and Distribution: Ketamir-2 demonstrated excellent stability in blood from various species, including humans.  This means that once in the bloodstream, Ketamir-2 remains unchanged for a sufficient duration, allowing it to potentially exert its therapeutic effects effectively.
  2. Metabolic Profile: The studies indicate the potential for Ketamir-2 to be metabolized effectively and safely.  The clear identification of specific liver enzymes hints at the potential for Ketamir-2 having fewer interactions with other medications, addressing a common concern among doctors and patients.
  3. Protein Binding: Ketamir-2 appears to bind optimally to blood proteins, which suggests the potential for effective delivery throughout the body.  This property is crucial for distributing the drug to brain areas where it can exert its effects.
  4. Safety Profiles: Initial toxicology assessments provide a favorable safety profile crucial for advancement through regulatory review and clinical trials.

Erez Aminov, Chairman & CEO of Mira Pharmaceuticals, shared, "The financial impact of medication-treated major depressive disorder in the U.S. stands at an overwhelming $92.7 billion annually, with $43.8 billion (47.2%) of this amount due to treatment-resistant depression1. Additionally, the U.S. market for post-traumatic stress disorder treatments is on a significant rise, projected to reach $26 billion by 20312.  In short, we are facing a mental health crisis in the U.S., and at MIRA Pharmaceuticals, we are developing Ketamir-2 to address these substantial market and medical needs."  

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 but also underscore its potential benefits for patients with TRD and PTSD and pave the way for what we believe will be straight forward IND-enabling development."

1 The Journal of Clinical Psychiatry, PMID: 33989464

2 Allied Market Research: Post-Traumatic Stress Disorder Treatment Market Research, 2031

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. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.

In addition, MIRA's novel oral pharmaceutical marijuana, MIRA-55, is currently under investigation for treating adult patients suffering from 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.

Additional information about the Company is available at: www.mirapharmaceuticals.com.

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 Ketamir-2's potential in treating certain mental health conditions.  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 (including the anticipated benefits of the Company's pre-clinical testing and pre-clinical data discussed herein) 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.

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SOURCE MIRA Pharmaceuticals, Inc.

Released April 2, 2024