MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ:MIRA) announced new preclinical data on Ketamir-2, its lead development product, will be presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024. The presentation, titled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase breakthrough findings where Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models.

Ketamir-2, a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 demonstrated superior efficacy to ketamine, achieving full normalization of pain response. MIRA plans to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with aims to demonstrate efficacy in humans as early as 2025.

Positive

• Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models
• Superior efficacy compared to ketamine in preclinical studies
• Potential for enhanced efficacy with fewer side effects compared to current treatments
• On track to submit IND application to FDA by December 2024
• Plans to demonstrate efficacy signal in humans as early as 2025

Negative

• None.

Insights

Medical Research Analyst

The preclinical data for Ketamir-2 shows remarkable promise in neuropathic pain treatment. Achieving 100% reversal of pain responses in the Chung model is a significant breakthrough, potentially outperforming existing therapies. This could be a game-changer for patients suffering from chronic neuropathic pain, a condition with effective treatments.

Key points to consider:

• Ketamir-2's selective targeting of the PCP site on NMDA receptors suggests enhanced efficacy with potentially fewer side effects compared to ketamine.
• The oral administration route could offer improved convenience and patient compliance over injectable alternatives.
• MIRA's aggressive timeline, aiming for an IND submission by December 2024 and a potential efficacy signal in humans by 2025, indicates confidence in the drug's potential.

However, investors should note that preclinical success doesn't guarantee clinical efficacy or regulatory approval. The transition from animal models to human trials is a critical and often challenging step in drug development.

Financial Analyst

While the preclinical results are promising, MIRA Pharmaceuticals is still in the early stages of drug development, which carries significant risks and costs. With a market cap of just $16,111,165, the company likely has financial resources to fund extensive clinical trials.

Key financial considerations:

• The timeline to potential commercialization is long, with clinical trials and regulatory approvals still ahead.
• R&D expenses are likely to increase significantly as the company moves towards clinical trials.
• Additional funding may be required, potentially leading to dilution for current shareholders.
• If successful, the neuropathic pain market represents a substantial opportunity, with global sales projected to reach $11.2 billion by 2027.

Investors should view MIRA as a high-risk, high-reward opportunity. The stock may experience volatility based on clinical development milestones and funding events. Diversification and careful portfolio management are important when considering such speculative investments.

Conference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic pain

MIAMI, FL / ACCESSWIRE / September 27, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company developing innovative therapies for neurologic and neuropsychiatric disorders, today announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA (the "Summit"). The presentation, entitled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase the breakthrough finding that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models.

The Summit is a leading forum for researchers, clinicians, and industry experts to discuss innovative solutions in pain management. MIRA Pharmaceuticals' participation highlights its commitment to addressing critical unmet medical needs in neuropathic pain, a chronic and debilitating condition with limited treatment options.

Neuropathic Pain and Ketamir-2's Promising Results

Neuropathic pain, caused by nerve damage or dysfunction, remains a major challenge in pain management due to the limited efficacy and significant side effects of current therapies. Ketamir-2 a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine.

In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 given orally, demonstrated superior efficacy compared to ketamine, achieving 100% reversal of pain responses, representing a full normalization of the response. These findings underscore Ketamir-2's potential as a breakthrough therapy for neuropathic pain, providing more consistent pain relief with reduced risk of adverse effects.

Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, who will be presenting the data at the Summit, commented:

"The data from our preclinical studies on Ketamir-2 are truly groundbreaking. Achieving a full normalization of response of neuropathic pain in our model suggests that Ketamir-2 has the potential to significantly outperform existing treatments, offering a new level of relief for patients suffering from chronic neuropathic pain. We are excited to present these findings to the broader scientific community and continue progressing toward clinical trials."

Ongoing Research and Future Plans

MIRA is advancing the development of Ketamir-2 through ongoing preclinical studies and is preparing to publish its findings in peer-reviewed journals. The company remains on track to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with plans to demonstrate an efficacy signal in humans as early as 2025. To achieve this, MIRA has designed strategic Phase I/II studies aimed at showcasing Ketamir-2's clinical effectiveness in treating neuropathic pain and potentially other neurological conditions. This approach underscores the company's commitment to accelerating the pathway to clinical success, delivering early and impactful data that will drive timely decision-making and help expedite patient access to innovative treatments.

Erez Aminov, CEO of MIRA, added:

"We are thrilled to present our preclinical data at the 18th Annual Pain Therapeutics Summit. Ketamir-2 represents a significant advancement in the treatment of neuropathic pain, and we are committed to accelerating its development to bring this novel therapy to patients in need."

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.

Forward Looking Statement

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.

Contact Information

Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: Mira Pharmaceuticals, Inc.

View the original press release on accesswire.com

FAQ

What are the key findings of MIRA Pharmaceuticals' Ketamir-2 preclinical studies for neuropathic pain?

Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models, demonstrating superior efficacy compared to ketamine. It showed full normalization of pain response in the Chung model of neuropathic pain.

When will MIRA Pharmaceuticals (NASDAQ:MIRA) present the Ketamir-2 preclinical data?

MIRA Pharmaceuticals will present the Ketamir-2 preclinical data at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024.

What are MIRA Pharmaceuticals' (NASDAQ:MIRA) plans for Ketamir-2's clinical development?

MIRA plans to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024 and aims to demonstrate an efficacy signal in humans as early as 2025 through strategic Phase I/II studies.

How does Ketamir-2 differ from traditional ketamine in treating neuropathic pain?

Ketamir-2 is a novel oral Ketamine analog that selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with potentially fewer side effects compared to traditional ketamine.