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By Meg Flippin, Benzinga

From cognitive impairments to depression-related illnesses, the current treatments aren’t doing enough. Sure, some may bring relief to the millions of people worldwide affected by neurological and neuropsychiatric disorders, but they come with a lot of side effects and accessibility challenges that can render them less than ideal. That leaves a gap in effective, safe and affordable solutions.

MIRA Pharmaceuticals (NASDAQ: MIRA) may have the answer. This preclinical-stage pharmaceutical company is focused on transforming the treatment of mental health disorders through scientific research and technological advancements. It's betting that its two compounds, MIRA-55 and Ketamir-2, will revolutionize mental health care.

Take MIRA-55 for starters. The novel compound aims to deliver the therapeutic benefits of THC and CBD without their associated side effects, such as increased appetite, paranoia and cognitive decline. It’s currently under investigation for treating neuropathic pain, anxiety and cognitive enhancements without the impurities of marijuana. In preclinical studies, MIRA-55 has shown the ability to double the memory of mice, in contrast to THC, which is known to impair memory, reports MIRA. MIRA-55 could be particularly beneficial for patients seeking cognitive enhancements and anxiety relief without the downside of impaired memory or other side effects.

Meanwhile, Ketamir-2, an oral ketamine analog designed to be taken as a pill, is being investigated for its potential antidepressant effects, particularly for treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation. Unlike traditional ketamine, which requires intravenous administration – posing accessibility and safety challenges – Ketamir-2 aims to simplify and improve the treatment experience.

The Science Behind Ketamir-2

Recent preclinical data reveals that Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site, avoiding interactions with opioid receptors, dopamine, serotonin transporters, and acetylcholine receptors. This unique selectivity may reduce side effects typically associated with traditional ketamine. Ketamir-2 has a 30- to 50-fold lower affinity to the PCP site compared to ketamine, which itself has about 10-fold lower affinity than PCP (Phencyclidine, Angel Dust). This is significant because ketamine was developed to be similar to PCP but with lower affinity, thereby reducing the risk of psychoactive side effects. In this respect, advocates consider Ketamir-2 a third-generation drug.

Moreover, Ketamir-2 is optimized for brain delivery. It is not a substrate for P-glycoprotein (P-gp), a membrane protein that pumps drugs out of cells, including those in the brain. This characteristic could allow Ketamir-2 to have better oral absorption and penetrate the blood-brain barrier more effectively than traditional ketamine, enhancing its therapeutic potential and bioavailability. Ketamir-2's oral bioavailability is predicted to be around 80%, which is significantly higher than traditional ketamine's 30%. Preclinical studies have shown that oral Ketamir-2 is safe at high doses and effective in several antidepressant and anxiolytic models. It does not appear to induce hyper-locomotor activity – a common side effect of traditional ketamine – and has shown no interaction with the mu-opioid receptor. MIRA says this could potentially mean a reduced risk of opioid-related side effects and dependency. Recent studies further highlight Ketamir-2's anti-depressive and anxiolytic effects in a mouse model, with significant improvements in behavioral tests compared to traditional ketamine.

A Step Toward Improved Patient Care

If MIRA is right about Ketamir-2, it has the potential to significantly positively impact mental health care, potentially helping millions of people through improved access and affordability. Traditional ketamine treatment for depression requires a Risk Evaluation and Mitigation Strategy (REMS) protocol due to its potential for abuse and severe side effects. This involves strict regulations, including the need for intravenous administration under medical supervision, making it less accessible and more costly for patients. In contrast, Ketamir-2, as an oral formulation, aims to provide a more convenient and less intimidating treatment option, with the ease of taking a pill at home potentially leading to better adherence to treatment regimens compared to frequent hospital visits for IV infusions.

By reducing the need for medical supervision and hospital visits, Ketamir-2 could enhance patient compliance and decrease overall treatment costs. Furthermore, MIRA reports that the U.S. Drug Enforcement Administration (DEA) has conducted a scientific review of both MIRA-55 and Ketamir-2 and determined that neither compound is classified as a controlled substance – significantly easing their regulatory pathway.

Exploring New Frontiers: Orphan Drug Indications

MIRA's journey doesn't stop at common mental health disorders. The company is exploring Ketamir-2's potential efficacy in treating chemotherapy-induced depression and cancer-related neuropathic pain. These conditions often have limited treatment options and significant patient populations in need of effective therapies.

Moreover, due to its novel chemical profile, MIRA is investigating options for orphan drug indications such as multiple sclerosis-induced depression and Huntington's disease-induced depression. The company believes these rare conditions could benefit from innovative treatments like Ketamir-2.

Market Potential And Patient Population

The market potential for MIRA Pharmaceuticals' compounds is substantial. Cognitive impairments, including conditions like Alzheimer's disease and dementia, affect millions of individuals. Close to seven million Americans are currently living with Alzheimer's, a number expected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association. Meanwhile, anxiety disorders affect over 40 million adults in the United States, according to the National Alliance on Mental Illness.

For depression, particularly treatment-resistant depression, the numbers are equally staggering. Approximately 17.6 million Americans are diagnosed with major depressive disorder, with 5.5 million reporting suicidal ideation and about 2 million having suicidal ideation with intent. The annual burden of medication-treated major depressive disorder in the United States is estimated at $92.7 billion, with $43.8 billion attributable to treatment-resistant depression.

Looking Ahead: The Path To Regulatory Approval

MIRA Pharmaceuticals reports that it is on track to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of this year. If granted, this would pave the way for human clinical trials, bringing Ketamir-2 closer to becoming a new standard of care for neurological and neuropsychiatric disorders. The company's commitment to advancing these compounds underscores its mission to address the unmet needs of patients suffering from debilitating conditions like depression, TRD and PTSD. For more information about MIRA Pharmaceuticals and its novel compounds, visit MIRA Pharmaceuticals.

Featured photo by Yuris Alhumaydy on Unsplash.

MIRA Pharmaceuticals, Inc., is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. We hold exclusive license rights in the U.S., Canada and Mexico for Ketamir-2, a novel, patent pending oral ketamine analog under pre-clinical investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (“TRD”), major depressive disorder with suicidal ideation (MDSI), and potentially post-traumatic stress disorder (“PTSD”).

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 that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2 and MIRA-55. Any forward-looking statements 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.

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Contact Details

Michelle Yanez

Myanez@mirapharma.com

Company Website

http://www.mirapharmaceuticals.com/

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