DEA Rules MIRA-55, an Oral Marijuana Analog, Not a Controlled Substance, Announces Mira Pharmaceuticals

MIAMI, May 29, 2024 – MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a company specializing in the pre-clinical development of treatments for neurologic and neuropsychiatric conditions, has announced a significant milestone regarding its investigational drug, MIRA-55. The U.S. Drug Enforcement Administration (DEA) has determined that MIRA-55 is not classified as a controlled substance or listed chemical under existing regulations.

MIRA-55 Overview and Benefits

MIRA-55 is being studied for its potential to treat neuropathic pain, anxiety, and cognitive decline often associated with early dementia. Unlike THC, the psychoactive component in marijuana, MIRA-55 has shown in pre-clinical studies to enhance memory by 100% in wild-type mice. This sets it apart from THC, which is known to impair cognitive functions.

Key Advantages of MIRA-55

1. Regulatory Edge: The DEA's decision not to classify MIRA-55 as a controlled substance provides a distinct advantage over marijuana, which faces stringent regulatory challenges. This classification eases the path for further research, development, and potential commercialization.

2. Cognitive Benefits: Pre-clinical models have demonstrated MIRA-55's ability to improve memory and cognitive performance, contrasting sharply with the cognitive impairments linked to marijuana use. Long-term marijuana use can lead to significant declines in I.Q. and other cognitive functions, particularly when usage starts during adolescence.

3. Stable Anti-Anxiety Effects: While THC displays a biphasic effect (anti-anxiety at low doses and pro-anxiety at high doses), MIRA-55 offers a more stable anti-anxiety profile across its dosage range. Marijuana use has been associated with various mental health issues, including depression, anxiety, and increased risks of psychosis and schizophrenia.

4. Reduced Intoxication: MIRA-55 shows lower potency at the CB1 receptor, responsible for THC's psychoactive effects, while maintaining higher activation of the CB2 receptor. This balance aims to deliver therapeutic benefits with minimal intoxicating effects, unlike marijuana, which can cause hallucinations, paranoia, and exacerbate symptoms in schizophrenia patients.

Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals, expressed enthusiasm about the DEA's ruling, highlighting it as a pivotal development for MIRA-55. "This decision allows us to advance MIRA-55's unique cognitive and anxiety benefits," he stated. Aminov also pointed out the significant market potential, with access to both the $90 billion traditional neurological market and the $30 billion cannabis market. 

Dr. Itzchak Angel, Chief Scientific Advisor, added insights into the prevalence of anxiety disorders and cognitive impairments in the U.S. Anxiety disorders affect around 40 million adults, presenting with symptoms like excessive worry, physical symptoms, and palpitations. Current treatments often take weeks to show effects and come with side effects. Cognitive impairment affects approximately 16 million people in the U.S., with limited effective treatments available. Dr. Angel emphasized that MIRA-55 offers a promising alternative with potential for quicker relief and fewer side effects for these conditions.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. is a pre-clinical-stage company focused on developing treatments for a broad spectrum of neurological and neuropsychiatric disorders. The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2, an oral ketamine analog under investigation for its rapid antidepressant effects. Ketamir-2 has also been determined by the DEA not to be a controlled substance. 

MIRA-55 is currently under pre-clinical investigation for treating neuropathic pain, anxiety, and cognitive decline. If approved by the FDA, MIRA-55 could represent a significant advancement in addressing various neuropsychiatric and neurological diseases.

While both Ketamir-2 and MIRA-55 are still in early pre-clinical stages, MIRA Pharmaceuticals is committed to advancing these compounds through the development pipeline, aiming to provide new therapeutic options for patients suffering from these challenging conditions.

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