• Promising Preclinical Results Position Ketamir-2 as a Potential Breakthrough Therapy That Surpasses Current Treatments, With Results to Be Presented at the Pain Therapeutics Summit in Boston

MIAMI, FL / ACCESSWIRE / October 28, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a leading pre-clinical-stage pharmaceutical development company, announces compelling new preclinical findings showing that Ketamir-2, a novel oral ketamine analog, achieves 60% greater efficacy than the FDA-approved neuropathic pain treatment gabapentin in reducing chemotherapy-induced pain. These results build on earlier successes across various pain models, further validating Ketamir-2's potential to set a new standard in pain management.

Study Overview and Results

The study used the paclitaxel (PTX) model, where neuropathic pain was induced in mice through the administration of PTX, a common chemotherapy drug. While effective in treating cancer, PTX often causes nerve damage, leading to chemotherapy-induced neuropathy characterized by pain, numbness, and tingling. To assess Ketamir-2's efficacy, mice received PTX every other day for four doses, and pain sensitivity was measured using the Von Frey filament (VFF) test. On Day 9, at the optimal dose of 300 mg/kg, Ketamir-2 led to near-complete normalization of pain sensitivity, outperforming FDA-approved gabapentin by 60%, which provided only moderate relief.

The company will present these findings, along with data from previous studies, at the upcoming Pain Therapeutics Summit in Boston on October 28-29, 2024, to showcase Ketamir-2's therapeutic potential to the medical community. This presentation emphasizes MIRA's commitment to sharing its data with the broader scientific community and engaging with key opinion leaders to discuss the significance of these findings. Sharing these results with leading experts will be crucial in advancing the understanding of Ketamir-2's potential as a groundbreaking treatment.

Potential for Breakthrough Therapy, Fast track and Priority Review

The promising results from this study could pave the way for Ketamir-2 to receive FDA breakthrough therapy designation, fast track, and/or priority review as an effective treatment for rare forms of cancer-related neuropathic pain, such as that associated with Multiple Myeloma. This rare cancer affects plasma cells in the bone marrow, leading to complications like bone damage and severe nerve pain. Treatments often include chemotherapy, which can induce significant neuropathic pain and greatly impact patients' quality of life.

Managing neuropathic pain in these patients remains challenging due to the limited availability of effective treatments. By focusing on this specific patient population, Ketamir-2 could potentially qualify for multiple FDA commercialization pathways, significantly reducing the time to market and accelerating patient access to the drug.

Expanding Therapeutic Potential and Accelerating Development

Building on consistent success in neuropathic pain models, MIRA is advancing its pipeline with studies assessing Ketamir-2 for diabetic neuropathy and other conditions. The company is preparing to submit an Investigational New Drug (IND) application by the end of 2024, with plans to begin Phase I clinical trials in the first quarter of 2025. To maximize the development timeline, MIRA is considering conducting multiple Phase II trials in parallel, specifically targeting neuropathic pain across different patient populations, which could further accelerate Ketamir-2's path to market.

In addition to the ongoing studies, MIRA is in the process of submitting several scientific journal publications that detail Ketamir-2's mechanism of action, as well as the results from its pain and depression studies. These publications aim to contribute to the broader scientific understanding of Ketamir-2's therapeutic potential.

Furthermore, Ketamir-2 is under evaluation for post-traumatic stress disorder (PTSD), with preclinical studies currently underway. MIRA is actively seeking government grants to support research on PTSD and other indications, positioning Ketamir-2 as a versatile non-opioid solution for various challenging conditions

A Safer, More Effective Approach to Pain Relief

As a non-opioid, Ketamir-2 addresses the limitations associated with existing treatments like FDA-approved gabapentin and pregabalin, which often come with side effects such as cognitive impairment, weight gain, and dependency risks. Ketamir-2 offers consistent and safer pain relief without these drawbacks, making it an ideal option for long-term management.

"Ketamir-2 has demonstrated exceptional efficacy across multiple models, achieving complete pain normalization where other treatments fall short," said Erez Aminov, Chairman and CEO of MIRA. "The potential for breakthrough therapy designation further highlights its promise to transform neuropathic pain management and accelerate access for patients in need."

"The impressive results achieved to date not only validate our approach but also signal a significant leap forward in pain management," added Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "We look forward to presenting these findings and discussing Ketamir-2's potential impact at the upcoming Pain Therapeutics Summit."

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 http://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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