MIRA Pharmaceuticals Releases Breakthrough Data from Artificial Intelligence Simulations

2023-12-04

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AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition

BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development.

In silico analysis is a computational technique that uses AI to predict the interaction between drugs and their targets. This innovative approach facilitates the virtual screening of compounds and the assessment of their pharmacological profiles before physical trials, expediting drug development and increasing the precision of therapeutic targeting.

"The results of our AI analysis work with InSilicoTrial's efforts continue to validate MIRA1a as a potential pharmaceutical candidate within a multi-billion-dollar market to address the unmet needs of millions with anxiety and cognition issues with potentially fewer negative side effects than THC," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "Following positive results from recent in vivo animal testing and research indicating MIRA1a's potential therapeutic effects, without the common negative side effects seen with THC even at high doses, we believe these targeted studies with InSilicoTrials employing artificial intelligence and machine learning further underscores MIRA1a's position as a promising development in the evolution of neuropharmacological therapies as we work towards the goal of filing an Investigational New Drug ("IND") Application with the Food and Drug Administration ("FDA")."

Decoding MIRA1a's Potential: A Possible Breakthrough in Anxiety, Appetite, and Cognition

Through meticulous computer-aided simulations, researchers have uncovered MIRA1a's predicted ability to initiate a response at three pivotal receptors in the brain— Serotonin 1a (5-HT1a), Serotonin 2c (5-HT2c), and Dopamine D1 receptors. Third-party studies indicate that THC has no predicted activity at any of these three receptors, highlighting MIRA1a's apparent unique properties and potential as an intervention for neurological disorders.

Unlocking Anxiety Relief: 5-HT1a Receptor Activation

The simulations suggest that MIRA1a's agonistic action on the 5-HT1a receptor aligns with established anxiolytic properties in medications like Buspirone and certain SSRIs. This finding could potentially result in providing a new therapy for anxiety disorder interventions by addressing disrupted signaling associated with this receptor.

Battling Appetite Concerns: 5-HT2c Receptor Modulation

The in silico analysis reveals MIRA1a's interaction with the 5-HT2c receptor, suggesting its potential to avoid the appetite related side effects often linked to THC. Drawing parallels with Lorcaserin, known for its FDA approved appetite-suppressing effects, MIRA1a stands out as a potentially viable solution for those seeking neuropharmacological relief from anxiety and cognitive impairment without the side effect of an increase in appetite that accompanies THC.

Cognitive Enhancement: Dopamine D1 Receptor Activation

MIRA1a's engagement with the Dopamine D1 receptor suggests a potential pathway for cognitive enhancement. With the potential to influence learning and memory, MIRA1a's activation of the D1 receptor may pave the way for novel interventions in disorders associated with cognitive impairment.

"In the groundbreaking field of neuropharmacology, artificial intelligence and machine learnings have ushered in a new era of drug discovery and analysis," said Adam Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA Pharmaceuticals. "Through the lens of AI, one gains a more complete demonstration of MIRA1a's potential properties at receptors that are not affected by THC. MIRA1a is uniquely positioned to potentially provide anti-anxiety effects, mitigate THC's known side effects of increased appetite, and promote enhanced cognition, making it an exceptional candidate for addressing complex neuropsychiatric conditions."

Luca Emili, Chief Executive Officer of InSilicoTrials, added, "Through this collaboration, InSilicoTrials and MIRA Pharmaceuticals are on a mission to optimize and de-risk drug development by using machine learning-based tools. Leveraging our advanced in silico platform and AI expertise, we contributed to enhance the development of MIRA1a, demonstrating the immense potential of collaborative innovation in the pharmaceutical sector."

For investors and industry leaders, MIRA1a represents not only a potential scientific breakthrough but also a significant commercial opportunity to meet the urgent need for additional neuropharmacological therapies following clinical trials and undergoing the FDA approval process.

About InSilicoTrials

InSilicoTrials is an emerging startup founded by a team of life science, cybersecurity and digital innovation experts, which aims to revolutionize Healthcare through an innovative digital simulation platform. We specialize in leveraging AI and simulations to enhance drug and medical device development. Using in silico techniques, we analyze data to predict safety and efficacy of potential compounds, aiding Pharma, MedTech companies, and researchers in efficient, cost-effective advancement by minimizing extensive clinical trials. InSilicoTrials' cloud-based platform offers advanced tools for in silico trials analyses, facilitating the integration of AI and simulation technology into development workflows.

About MIRA Pharmaceuticals, Inc.

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. The Company's novel oral pharmaceutical marijuana, MIRA1a, 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.

MIRA has an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI).

The U.S. Drug Enforcement Administration (DEA)'s scientific review of MIRA1a and Ketamir-2 concluded that neither would be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

Additional information about the Company is available at: www.mirapharmaceuticals.com.

Forward-Looking Statements

This press release may contain forward-looking statements about MIRA Pharmaceuticals, Inc. ("MIRA," "we," "us," or "our"). In some cases, you can identify forward-looking statements by terminology such as "anticipate,' "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would," or the negative of these terms or other comparable terminology. These forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including risks and uncertainties regarding our ability to develop and obtain regulatory approval for our product candidates, Ketamir-2 and MIRA1a. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, levels of activity, performance or achievements of and those of our industry to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Some of these risks and uncertainties are identified in our Registration Statement on Form S-1 filed with the SEC (File No. 333-273024) and in our other filings with the SEC, which are available at www.sec.gov. You

should not place undue reliance on any forward-looking statement. We undertake no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law.

General Note

This press release discusses product candidates that are in early stage pre-clinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration. No representations are made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. There is no assurance that either product candidate will proceed through development or will receive FDA approval for marketing.

SOURCE MIRA Pharmaceuticals, Inc.