MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ:MIRA) announces successful completion of Good Laboratory Practice preclinical safety program for Ketamir-2, their novel oral ketamine analog. The studies showed no adverse findings across multiple safety assessments, including cardiovascular safety in dogs, CNS assessment in rats, and respiratory safety tests.

The company plans to submit an Investigational New Drug (IND) application by end of 2024, with Phase I clinical trials scheduled to begin in Q1 2025. The trial design includes pain tests to evaluate effects on neuropathic pain and psychosis, with data expected by Q2 2025. A Phase IIa proof-of-concept study is planned for Q4 2025, with results anticipated by year-end.

Positive

• Successful completion of preclinical safety program with no adverse findings
• On track for IND submission by end-2024
• Clear clinical development timeline with Phase I starting Q1 2025
• Strong safety profile validated across multiple studies
• Ketamir-2 well-tolerated at daily doses up to 200 mg/kg in dogs
• Non-mutagenic results in Ames Test

Negative

• None.

Insights

Medical Research Analyst

The successful completion of MIRA's GLP preclinical safety program for Ketamir-2 represents a significant milestone in drug development. The comprehensive safety data package, including cardiovascular, CNS, respiratory and toxicology studies, demonstrates a remarkably clean safety profile. The established NOAEL at 200 mg/kg in dogs and negative Ames test results are particularly encouraging, suggesting a wide therapeutic window.

The innovative Phase I trial design, incorporating pain evaluation metrics in healthy volunteers, could accelerate the development timeline and provide early efficacy signals. This approach could significantly reduce the risk and cost of subsequent patient trials while providing valuable pharmacodynamic data. The planned transition from IND submission to Phase IIa results within approximately 12 months is ambitious but achievable given the strong preclinical foundation.

Financial Analyst

With a market cap of just $19.9 million, MIRA's successful preclinical safety validation significantly de-risks their lead asset and could catalyze substantial value creation. The company's strategic focus on generating proof-of-concept data for potential M&A or partnerships is particularly noteworthy given the current market dynamics where big pharma actively seeks de-risked assets in the pain management space.

The accelerated development timeline, targeting proof-of-concept data by end-2025, positions MIRA for multiple value-creating catalysts throughout 2024-2025. While the company claims to have sufficient resources, their current market cap suggests potential future financing needs. However, positive safety data and clear development pathway could attract non-dilutive financing options or strategic partnerships.

Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain

MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse findings, clearing a critical milestone as the Company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.

"Our commitment to advancing Ketamir-2 into clinical trials as quickly as possible reflects our strategic focus on generating proof-of-concept data that positions MIRA for a potential M&A transaction or strategic partnership," said Erez Aminov, CEO and Chairman of MIRA. "This milestone demonstrates our ability to execute efficiently and reinforces our dedication to delivering innovative, safe, and effective treatments for patients suffering from neuropathic pain."

The Significance of Safety in Drug Development

Safety is one of the most significant factors influencing the success of drug development and regulatory approval. Industry data shows that nearly 40% of drug failures during clinical development are attributed to safety concerns, making it a primary reason for termination at all stages of research. Additionally, drugs with unresolved safety questions often face post-market challenges, with 30% of FDA-approved drugs receiving post-market safety warnings or label changes.

By demonstrating Ketamir-2's robust safety profile in comprehensive preclinical studies, MIRA has significantly de-risked this critical aspect of drug development. This milestone positions the company for a smoother regulatory pathway and potentially increases the likelihood of successful clinical outcomes.

Highlights of Preclinical Findings:

• Cardiovascular Safety in Dogs: No adverse effects were noted at therapeutic doses.

• CNS Assessment in Rats: No significant CNS changes were observed at therapeutic dose levels, confirming a favorable safety profile. Effects in high-dose groups were limited, transient, and non-disruptive.

• Respiratory Safety in Rats: No respiratory-related effects were noted across all tested doses.

• 14-Day Toxicology in Dogs: Ketamir-2 was well-tolerated at daily doses up to 200 mg/kg, with no observed adverse effects. This dose established the No Observed Adverse Effect Level (NOAEL).

• Ames Test: Ketamir-2 was confirmed to be non-mutagenic, further supporting its safety profile.

Path to Clinical Trials

With the current preclinical safety program successfully completed, MIRA remains on schedule to submit its IND application by the end of 2024. The Phase I clinical trial, set to begin in Q1 2025, is designed to gather critical insights into the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ketamir-2 in healthy subjects. Importantly, the trial will include a robust battery of pain tests to evaluate the drug's effects on neuropathic pain and psychosis. These evaluations are expected to provide valuable data by Q2 2025, helping to better understand how Ketamir-2 affects pain in humans prior to initiating Phase IIa trials in patients.

This innovative study design allows for early efficacy data to be gathered in healthy volunteers, providing deeper insights into Ketamir-2's therapeutic potential and optimizing the design of future trials. Building on the Phase I findings, MIRA plans to initiate a Phase IIa proof-of-concept study in Q4 2025, focusing on patients with neuropathic pain. Proof-of-concept results are anticipated by year-end 2025, marking a transformative year as MIRA transitions into a clinical-stage pharmaceutical company.

Powerful Endorsement from Scientific Leadership

"The robust safety data we've generated for Ketamir-2 is nothing short of extraordinary," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "This is a pivotal moment, not just for MIRA, but for the millions of patients suffering from neuropathic pain who are waiting for a safe, non-addictive, and effective treatment. Ketamir-2 represents a groundbreaking step forward in addressing unmet medical needs, and I am confident that it has the potential to redefine treatment paradigms in this space. By strategically designing our Phase I trial to include a comprehensive pain evaluation, we are maximizing the insights we can gain early, positioning us to move into patient trials with a strong understanding of the drug's effects in humans."

A Safer Path to Addressing Unmet Needs

The need for safe, non-addictive treatments for neuropathic pain is pressing, with millions of patients worldwide seeking alternatives to existing therapies that often cause intolerable side effects. By addressing this unmet need with a drug that has a strong safety profile, MIRA aims to set a new standard in neuropathic pain management. Safety validation at this stage also reduces the risk of clinical delays, maximizes resource efficiency, and enhances the opportunity for meaningful collaborations.

Financial and Strategic Position

MIRA believes it has a strong financial position that can potentially ensure the resources necessary to achieve clinical milestones. The Company is actively exploring non-dilutive funding opportunities to accelerate development and maximize the therapeutic impact of Ketamir-2.

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.

Contact Information

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

SOURCE: Mira Pharmaceuticals, Inc.

View the original press release on accesswire.com

FAQ

When will MIRA Pharmaceuticals submit the IND application for Ketamir-2?

MIRA Pharmaceuticals (NASDAQ:MIRA) plans to submit the Investigational New Drug (IND) application for Ketamir-2 by the end of 2024.

What were the key findings from Ketamir-2's preclinical safety studies?

The preclinical studies showed no adverse effects in cardiovascular safety (dogs), CNS assessment (rats), and respiratory safety tests. Ketamir-2 was well-tolerated at doses up to 200 mg/kg in dogs and proved non-mutagenic in the Ames Test.

When will MIRA Pharmaceuticals begin Phase I clinical trials for Ketamir-2?

MIRA Pharmaceuticals plans to begin Phase I clinical trials for Ketamir-2 in Q1 2025, with initial data expected by Q2 2025.

What is the timeline for MIRA's Phase IIa trials for Ketamir-2?

MIRA plans to initiate Phase IIa proof-of-concept studies for Ketamir-2 in Q4 2025, with results expected by the end of 2025.