• This breakthrough in bioavailability and formulation showcases the potential for advanced, at home neurological treatments.

MIAMI, FL / ACCESSWIRE / August 12, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA Pharmaceuticals, a leading pre-clinical-stage pharmaceutical company unveiled new preclinical data providing further insights into the mechanism of action of its innovative drug candidate, Ketamir-2's principal metabolite, Nor-Ketamir-2. This data indicates that similar to Ketamir-2, its principal metabolite, Nor-Ketamir-2 selectively interacts with a low affinity at the NMDA PCP site with high selectivity and lack of activity on the glutamate NMDA site, opiate and other sites. Additionally, a new salt, Ketamir-2 Pamoate and associated formulation, were developed to potentially enhance pharmacokinetics and improve brain penetration, achieving higher plasma and brain levels with longer half-life, with nearly 100 percent oral bioavailability of Nor-Ketamir-2.

Traditional ketamine, while effective, suffers from very low oral bioavailability (less than 30%) and poses significant safety concerns due to its interaction with multiple NMDA and other receptor sites. This often necessitates intravenous or intranasal administration, which limits its practicality for at-home use. In contrast, Ketamir-2 and its principal metabolite, Nor-Ketamir-2, demonstrate superior selectivity and bioavailability in preclinical studies. Upon oral absorption, the body efficiently metabolizes Ketamir-2 into Nor-Ketamir-2, leading to sustained plasma residence and brain penetration and extended therapeutic efficacy, making it a promising candidate for at-home treatment.

The development of the Ketamir-2 Pamoate with a new formulation is particularly significant. This new formulation enhances pharmacokinetics, ensuring that the body effectively absorbs and utilizes both Ketamir-2 and Nor-Ketamir-2. With Nor-Ketamir-2 achieving near 100 percent oral bioavailability, the drug can maintain higher levels in the bloodstream for extended periods, allowing for sustained therapeutic action and potentially reducing the frequency of dosing.

Summary of Key Findings:

Enhanced Bioavailability: The new Pamoate salt and formulation brings Nor-Ketamir-2's bioavailability close to 100%, a significant improvement over traditional ketamine's less than 30% oral bioavailability.

Sustained Brain Penetration: The extended half-life and elevated levels of Nor-Ketamir-2 observed in preclinical studies suggest prolonged therapeutic effects, which are essential for effective at-home treatment.

Improved Safety Profile: Unlike traditional ketamine, which interacts with multiple receptor sites, Ketamir-2 and Nor-Ketamir-2 demonstrate a cleaner pharmacological profile, potentially reducing the risk of adverse effects.

Ongoing Studies and Regulatory Progress:

MIRA Pharmaceuticals is also actively conducting studies to explore potential indications that will allow for a quicker pathway to approval, such as indications for cancer neuropathic pain and chemo-induced depression, as well as neuropathic pain and PTSD. The company has commenced IND enabling regulatory work and is progressing with its Good Manufacturing Practice (GMP) drug scale-up. MIRA plans to submit an Investigational New Drug (IND) application by the end of the year, marking a crucial step towards clinical trials.

"Our mission at MIRA Pharmaceuticals is to improve the affordability, accessibility, and safety of treatments for neurological and neuropsychiatric disorders," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. "The latest preclinical data on Ketamir-2 highlight our commitment, bringing us closer to filing an IND and starting clinical trials."

Dr. Itzchak Angel, PhD, Chief Medical Advisor of the Company, added, "Traditional ketamine's limitations, including its low oral bioavailability and extensive receptor interactions, have hindered its widespread use. Our recent findings with Nor-Ketamir-2 and Ketamir-2 Pamoate highlight remarkable improvements in extending efficacy and bioavailability, suggesting a potentially safer and more effective treatment that could be administered at home. The extended half-life and elevated levels of Nor-Ketamir-2 observed in preclinical studies support its potential for prolonged therapeutic action."

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 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 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 MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about MIRA Pharmaceuticals is available at: 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 and the statements of MIRA Pharmaceuticals' (or the "Company") 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.

Contact Information

Erez Aminov
Chairman & Chief Executive Officer
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(786) 432-9792