MIRA MIRA Pharmaceuticals Inc

Ketamir-2, the Company's novel oral ketamine analog in development, aims to provide a safe and effective alternative for managing cancer pain and associated depression

MIAMI, May 21, 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, announced it is in advanced discussions with Memorial Sloan Kettering Cancer Center (MSK) to initiate a preclinical study evaluating MIRA's novel oral ketamine analog, Ketamir-2, for the treatment of cancer-related pain and depression.

This collaboration with MSK, one of the top cancer centers in the world, would represent an important validation of the potential for Ketamir-2. This underscores MIRA's commitment to broadening the potential uses of its novel compound beyond treatment-resistant depression, major depressive disorder, and post-traumatic stress disorder, which MIRA is already studying in a preclinical setting.

Currently, MSK treats pain in patients with refractory cancer (meaning cancer that has not responded to initial treatment or is getting worse) using intravenous (IV) ketamine, among other methods. However, MIRA's novel oral ketamine analog presents a promising alternative due to its potential for high oral bioavailability and lack of interaction with mu opioid receptors, which potentially enhances its safety profile.  Oral administration is more convenient and less invasive than IV treatments and would potentially enable in-house treatment, as opposed to the current method of in-hospital treatment. The aim of this collaboration would be to assess the potential of oral Ketamir-2, in comparison with non-oral administration of ketamine, to alleviate symptoms of cancer pain in a rodent animal model.  In parallel, MIRA is exploring the effects of Ketamire-2 on neuropathic pain within the framework of its collaboration with Pharmaseed Ltd.

"We view a proposed partnership with Memorial Sloan Kettering as immensely validating of our efforts to develop Ketamir-2.  Our groundbreaking oral ketamine analog not only offers patients a potentially safer and more convenient treatment option but also holds tremendous potential to disrupt the oncology pain market as well as the other potential uses we are currently exploring.  This collaboration underscores our commitment to innovation and improving patient outcomes" said Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals. 

"While opioid therapy is still used as the standard of care for management of cancer pain, multimodal treatment options are needed to reduce the risk of opioid tolerance, abuse and divergence. Clinically, the potential for ketamine-like and cannabinoids for the treatment of cancer pain has been very promising. Our experience at Memorial Sloan Kettering Cancer Center with intravenous ketamine and cannabinoids further support development for oral medications with a favorable safety profile for the treatment of cancer pain.  We are excited about the potential treatment options presented by MIRA, Ketamir-2 and Mira-55. These compounds should improve the lives of our cancer pain patients" said Dr. Amitabh Gulati, Director Chronic Pain, Memorial Sloan Kettering and Board Member of Cancer Pain Research Consortium.

The novel oral ketamine analog developed by MIRA aims to provide a safe and effective alternative for managing cancer pain and associated depression. This therapeutic could potentially streamline the regulatory approval process by leveraging its novel properties, allowing for an accelerated clinical studies as combined Phase 1/2 clinical trial. Successful outcomes from the preclinical study could potentially accelerate the pathway for U.S. Food and Drug Administration approval of an Investigational New Drug Application for Ketamir-2 over the next year and open opportunities for non-dilutive funding, enhancing MIRA's capacity to deliver groundbreaking treatments to needy patients in the future.

"As we seek to join forces with Memorial Sloan Kettering, we are aiming to redefine the standard of care in cancer pain management. Our novel oral ketamine analog shows great potential in offering patients safer and more accessible treatment options, including the ability to treat depression, which is common among cancer patients. This collaboration marks a significant step forward in our mission to transform the landscape of oncology therapeutics" said Dr. Itzchak Angel, Chief Scientific Advisor to MIRA Pharmaceuticals.

Cancer Pain Market

Cancer pain is a significant and pervasive issue among cancer patients. Research indicates that approximately 44% of cancer patients experience pain, with about 31% enduring moderate to severe pain¹. This prevalence is consistent across multiple studies, including a 2023 review of over 10,000 studies and a 2021 systematic review of research conducted between 2014 and 2021^{2 3}. Additionally, the National Cancer Institute reports that around 25% of cancer patients suffer from depression, a rate substantially higher than the general population⁴.

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, 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.

Ketamir-2 and MIRA-55 are in early-stage preclinical development. There is no assurance that the products will proceed through development or receive FDA approval for marketing.

About Memorial Sloan Kettering Cancer Center

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians who go on to pursue our mission at MSK and around the globe. One of the world's most respected comprehensive centers devoted exclusively to cancer, we have been recognized as one of the top two cancer hospitals in the country by U.S. News & World Report for more than 30 years.

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 the potential for the Company's collaboration with MSK (which are not finalized and might not occur) and statements regarding the timing for the Company's 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.

¹ Fightcancer.org – Cancer Pain Statistics

² 2023 Systematic Review on Cancer Pain

³ 2021 Review of Studies on Cancer Pain (2014-2021)

⁴ National Cancer Institute – Depression in Cancer Patients

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SOURCE MIRA Pharmaceuticals, Inc.