Mira Pharmaceuticals Announces Encouraging Preclinical Results Advancing Ketamir-2 Towards Potential Year-End IND Submission

Rhea-AI Summary

MIRA Pharmaceuticals, Inc. shares updates on the pre-clinical studies of Ketamir-2, a potential treatment for major mental health disorders. Ketamir-2, a novel oral ketamine analog, shows promising results for treatment-resistant depression, major depressive disorder with suicidal ideation, and post-traumatic stress disorder. The compound demonstrates excellent stability in blood, safe metabolism, and optimal protein binding. The company aims to file an IND with the FDA by year-end for human testing.

Insights

Pharmacologist

The recent findings from MIRA Pharmaceuticals regarding Ketamir-2 are indicative of a drug with a promising pharmacological profile. The in vitro research showing stability in blood, a favorable metabolic profile and optimal protein binding are all positive indicators for the potential efficacy and safety of this compound. From a pharmacological standpoint, these characteristics are essential for ensuring the drug remains active for the necessary duration, is processed without producing harmful metabolites and reaches the target tissues effectively.

Moreover, the identification of specific liver enzymes involved in the metabolism of Ketamir-2 could imply a lower risk of drug-drug interactions. This is particularly relevant for patients who may be on multiple medications, which is common in the population targeted by this treatment. The initial toxicology assessments that suggest a favorable safety profile are also critical, as they are a primary concern during the drug development process and can be a significant hurdle in obtaining FDA approval for human trials.

Health Economics Expert

Assessing the economic implications of Ketamir-2, the potential impact on the market for major mental health disorders could be substantial. Given the current financial burden of medication-treated major depressive disorder and PTSD in the U.S., a new effective treatment could lead to significant cost savings in the healthcare system. The CEO's statement regarding the annual cost of treatment-resistant depression and the growing market for PTSD treatments highlights the economic opportunity for a successful drug like Ketamir-2.

It is important to consider that the development and approval of new treatments can alter the competitive landscape, potentially leading to market share redistribution and affecting the profitability of existing treatments. If Ketamir-2 proves to be effective and safe in human trials, it may become a preferred treatment option, thus impacting the revenue streams of other pharmaceutical companies in this space.

Biotech Market Analyst

For investors and stakeholders in the biotech sector, the progress of Ketamir-2 represents a critical juncture. The move towards filing an Investigational New Drug Application is a significant step in the drug development process. If the IND is accepted, it could lead to a surge in investor confidence, potentially influencing MIRA's stock value. The focus on treatment-resistant depression, major depressive disorder with suicidal ideation and PTSD also taps into a large and growing patient population, which could translate into a lucrative revenue stream if the drug reaches the market.

However, it's essential to remain cautious, as pre-clinical success does not guarantee clinical success. The transition from in vitro to in vivo and eventually to human studies is fraught with challenges and many compounds fail to demonstrate the same level of efficacy or safety in later stages of testing. The long-term potential of Ketamir-2 hinges on these critical phases of development. Investors should closely monitor MIRA's progress and any emerging data from future clinical trials.

Ketamir-2 is a potential treatment for certain major mental health disorders impacting millions of people in the U.S.

MIAMI, April 2, 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, today shares updates on the ongoing pre-clinical studies of its investigational compound, Ketamir-2, a novel oral ketamine analog which could potentially deliver ultra-rapid antidepressant effects. 

MIRA is conducting pre-clinical studies of Ketamir-2 in collaboration with Frontage Laboratories as a potential treatment for individuals battling treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI) and post-traumatic stress disorder (PTSD).  MIRA is hopeful that the encouraging results of these most recent studies will enable MIRA to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration by the end of this year which, if accepted, would allow for human testing of Ketamir-2. 

The latest in vitro research focused on Ketamir-2's stability in the bloodstream, its metabolism (processing by the body), and how it binds to proteins in the blood.  These factors play a crucial role in determining a drug's adequacy and likelihood for acceptable safety, its pharmacological profile and potential modes of administration to patients.

1. Blood Stability and Distribution: Ketamir-2 demonstrated excellent stability in blood from various species, including humans.  This means that once in the bloodstream, Ketamir-2 remains unchanged for a sufficient duration, allowing it to potentially exert its therapeutic effects effectively.
2. Metabolic Profile: The studies indicate the potential for Ketamir-2 to be metabolized effectively and safely.  The clear identification of specific liver enzymes hints at the potential for Ketamir-2 having fewer interactions with other medications, addressing a common concern among doctors and patients.
3. Protein Binding: Ketamir-2 appears to bind optimally to blood proteins, which suggests the potential for effective delivery throughout the body.  This property is crucial for distributing the drug to brain areas where it can exert its effects.
4. Safety Profiles: Initial toxicology assessments provide a favorable safety profile crucial for advancement through regulatory review and clinical trials.

Erez Aminov, Chairman & CEO of Mira Pharmaceuticals, shared, "The financial impact of medication-treated major depressive disorder in the U.S. stands at an overwhelming $92.7 billion annually, with $43.8 billion (47.2%) of this amount due to treatment-resistant depression¹. Additionally, the U.S. market for post-traumatic stress disorder treatments is on a significant rise, projected to reach $26 billion by 2031².  In short, we are facing a mental health crisis in the U.S., and at MIRA Pharmaceuticals, we are developing Ketamir-2 to address these substantial market and medical needs."  

Itzchak Angel, Ph.D., MIRA's Chief Scientific Advisor, added, "The data we have obtained from these studies is invaluable. They not only enhance our understanding of Ketamir-2 but also underscore its potential benefits for patients with TRD and PTSD and pave the way for what we believe will be straight forward IND-enabling development."

¹ The Journal of Clinical Psychiatry, PMID: 33989464

² Allied Market Research: Post-Traumatic Stress Disorder Treatment Market Research, 2031

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.  

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.

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 Ketamir-2's potential in treating certain mental health conditions.  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 (including the anticipated benefits of the Company's pre-clinical testing and pre-clinical data discussed herein) 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.

View original content:https://www.prnewswire.com/news-releases/mira-pharmaceuticals-announces-encouraging-preclinical-results-advancing-ketamir-2-towards-potential-year-end-ind-submission-302105198.html

SOURCE MIRA Pharmaceuticals, Inc.

FAQ

What is the investigational compound being studied by MIRA Pharmaceuticals?

MIRA Pharmaceuticals is studying Ketamir-2, a novel oral ketamine analog, as a potential treatment for major mental health disorders.

What are the target conditions for Ketamir-2?

Ketamir-2 is being studied as a potential treatment for treatment-resistant depression, major depressive disorder with suicidal ideation, and post-traumatic stress disorder.

What are some key findings from the pre-clinical studies of Ketamir-2?

Key findings include excellent stability in blood, safe metabolism, optimal protein binding, and a favorable safety profile.

What is the financial impact of major depressive disorder in the U.S.?

Medication-treated major depressive disorder in the U.S. has an annual financial impact of $92.7 billion, with $43.8 billion attributed to treatment-resistant depression.

What is the projected market size for post-traumatic stress disorder treatments in the U.S. by 2031?

The U.S. market for post-traumatic stress disorder treatments is projected to reach $26 billion by 2031.