• Study Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain Thresholds

MIAMI, FL / ACCESSWIRE / August 26, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, is proud to announce a major breakthrough in the treatment of neuropathic pain. A recent pre-clinical study in rats demonstrated that its novel oral ketamine analog, Ketamir-2, produced a significant reversal of neuropathic pain, induced by nerve ligation, culminating in a 100% normalization of pain thresholds at the highest dose. This effect stands in stark contrast to traditional ketamine, which proved ineffective orally under the same experimental conditions.

The study, conducted at Pharmaseed Ltd, utilized a nerve ligation model to replicate human neuropathic pain and specifically investigates mechanical allodynia. The results were compelling: low oral doses of Ketamir-2 led to a significant reversal of pain for 14 and 22 days following the operation. At higher oral dose, Ketamir-2 achieved complete normalization of the pain threshold, representing a 100% reversal of the neuropathic pain signal. These outcomes underscore Ketamir-2's superior efficacy and highlight its potential as a transformative treatment for neuropathic pain, especially compared to oral ketamine, which did not deliver significant pain relief.

In light of this compelling data, MIRA Pharmaceuticals is conducting additional studies to evaluate Ketamir-2's efficacy in treating cancer-induced depression and neuropathic pain. These studies aim to explore cancer-related indications, which could pave the way for faster regulatory approvals and innovative clinical study designs. MIRA is optimistic that these efforts could demonstrate efficacy in humans as early as 2025.

"The development of Ketamir-2 as an oral treatment for neuropathic pain is a significant milestone not only for MIRA but for the entire field of neuropsychiatric and neurologic disorder therapies," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. "Neuropathic pain is a debilitating condition that imposes an enormous burden on patients, often leaving them with limited and ineffective treatment options. These findings suggest that Ketamir-2 could offer patients a more accessible, safer, and effective treatment option, potentially transforming the standard of care for neuropathic pain."

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA Pharmaceuticals, added, "The ability to administer Ketamir-2 orally without the severe psychotropic side effects commonly associated with ketamine is a remarkable achievement. This positions Ketamir-2 as a pioneering treatment in the realm of neuropathic pain, offering hope to patients who have limited options available."

MIRA Pharmaceuticals continues to advance its research, focusing on scaling production and preparing for the next stages of clinical trials. The company remains committed to bringing safer and more effective treatments to market, with Ketamir-2 at the forefront of its pipeline.

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.

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