MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development

MIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.

Erez Aminov, Chairman & CEO of Mira, stated: "This IND submission highlights our team's commitment to executing efficiently as we advance transformative therapies. Ketamir-2 not only has demonstrated remarkable potential for neuropathic pain but also offers a broad opportunity across other major neuropsychiatric conditions. We look forward to beginning Phase I trials and continuing to deliver on our mission to address unmet medical needs."

The IND application includes comprehensive data and reports detailing Ketamir-2's pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models. In parallel with the submission, the company is preparing to conduct a complementary neurotoxicity study, as required by the FDA's written feedback to the pre-IND documentation.

According to a market analysis report from Fortune Business Insights, the neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate (CAGR), reaching $4.5 billion by 2030. Despite this growth, existing treatments remain inadequate. Gabapentin and pregabalin, while widely prescribed, provide limited efficacy and are associated with side effects such as sedation, dizziness, and weight gain. Opioids remain a common treatment option but come with well-known risks of dependency, addiction, and respiratory depression. Intravenous ketamine, though effective for some patients, requires invasive administration and is often associated with psychotropic side effects, including hallucinations and dissociation.

Ketamir-2 is specifically designed to address the limitations of existing treatments through its selective targeting of the NMDA receptor. By binding to a specific site on the NMDA receptor with low affinity, Ketamir-2 significantly reduces the risk of psychotropic effects commonly associated with traditional ketamine. Furthermore, it is not a substrate for P-glycoprotein (P-gp), which allows for better oral absorption and enhanced blood-brain barrier penetration. Unlike traditional ketamine, Ketamir-2 does not cause sedation or hyperactivity-side effects often linked to psychiatric conditions such as schizophrenia, bipolar mania, and ADHD. As a non-opioid therapy, Ketamir-2 is designed to eliminate the risks of dependency and addiction. Additionally, the DEA has determined that Ketamir-2 is not a controlled substance, streamlining accessibility and minimizing regulatory hurdles.

Preclinical studies have demonstrated Ketamir-2's ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models. Furthermore, Ketamir-2 has shown a strong safety and toxicological profile, observed across cardiovascular, CNS, respiratory, or toxicology assessments.

Dr. Itzchak Angel, Chief Scientific Advisor at Mira, commented: "Ketamir-2's selective mechanism of action, strong safety profile, and ability to achieve full pain reversal underscore its potential as a transformative therapy."

With the IND submitted, MIRA expects to initiate Phase I Clinical Trials in Q1 2025 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Phase IIa trials are expected to follow in late 2025 to assess efficacy in neuropathic pain patients. Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including MDD, MDD-SI, TRD and PTSD.

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 treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD).

MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations.

Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contain "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 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. 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 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 the 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.