MIRA Pharmaceuticals Enters Transformative Collaboration to Commercialize Ketamine Analog for Depression

Pharmaceutical company, MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) has entered an exclusive licensing agreement with MIRALOGX, giving it the exclusive rights to develop and commercialize Ketamir-2 in the United States, Canada, and Mexico. Ketamir-2 is a novel oral ketamine analog designed to revolutionize the landscape of depressive disorder treatments. The company’s shares soared 40% following the news.

The collaboration includes a $3 million line of credit extended by MIRALOGX to fund the initial development of Ketamir-2.

Dr. Adam Kaplin, MD, PhD, MIRA’s President and Chief Scientific Officer, said, “In our continuing pursuit to alleviate the burden of treatment-resistant depression, the development of Ketamir-2 offers a promising beacon of hope. I am honored to lead its development journey and am optimistic about its potential to transform the lives of individuals suffering from treatment resistant and suicidal depression.”

Erez Aminov, Chief Executive Officer of MIRA, added, “The combination of this exclusive licensing agreement and obtaining initial funding for development through the MIRALOGX line of credit propels MIRA into an exciting phase of innovation and development.”

Highlights

Ketamir-2 is a unique patent-pending compound is under investigation to potentially deliver ultra-rapid antidepressant effects as early as four hours after dosing, providing hope for individuals battling treatment-resistant depression and major depressive disorder with suicidal ideation.

A salient feature of Ketamir-2 is its potential superior bioavailability. Unlike Ketamine, which necessitates intravenous, intramuscular, or intranasal administration due to its limited oral bioavailability, in initial preclinical studies, Ketamir-2 appears to exhibit a more clinically desirable gastrointestinal absorption profile.

Dr. Adam Kaplin, an esteemed expert in ketamine research and an adjunct faculty member at Johns Hopkins Medicine, will lead the development of Ketamir-2.

Following scientific review, the U.S. Drug Enforcement Administration has concluded that Ketamir-2 is not a controlled substance or listed chemical under the Controlled Substances Act.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company developing an unscheduled novel synthetic THC analog. This novel compound is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA1a, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. Based on pre-clinical and animal studies conducted by the Company, the Company believes that MIRA1a may enhance the therapeutic potential for treating anxiety, cognitive decline, and neuropathic pain without the side effects of plant-based THC. Furthermore, the Company’s studies show that MIRA1a may counteract the adverse cognitive effects often seen with THC, thereby potentially unmasking previously unseen positive therapeutic effects, such as cognitive performance enhancement.

The U.S. Drug Enforcement Administration (DEA)’s scientific review of MIRA1a concluded that MIRA1a would not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development.