MIRA Pharmaceuticals Expands Ketamir-2 Development with Topical Treatment for Localized Neuropathic and Inflammatory Pain

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ:MIRA) has successfully developed a topical formulation of Ketamir-2 for localized neuropathic and inflammatory pain treatment, expanding beyond its existing oral formulation. The topical treatment is designed for slow release, providing targeted pain relief while minimizing systemic exposure and side effects.

The new formulation targets multiple conditions including:

• Neuropathic pain conditions (diabetic neuropathy, postherpetic neuralgia)
• Inflammatory pain conditions (osteoarthritis, rheumatoid arthritis)
• Nerve compression & musculoskeletal pain

MIRA's clinical progress includes:

• Ongoing Phase 1 trial for oral Ketamir-2
• Preclinical PTSD studies
• Planned Phase 2a study for diabetic neuropathy by year-end
• Animal study for topical Ketamir-2
• MIRA-55 preclinical studies for memory enhancement

Positive

• Successful development of new topical formulation expands product pipeline
• Multiple potential commercial applications across various pain conditions
• Phase 1 clinical trial for oral treatment progressing as planned
• Strategic positioning in both oral and topical pain management markets

Negative

• No efficacy data available yet for the new topical formulation
• Phase 2a trials not yet initiated
• Long timeline to market with first efficacy data expected Q1 2026

Insights

Pharmaceutical Research Expert

MIRA Pharmaceuticals' announcement represents a significant expansion of their development pipeline with the successful formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain. This strategic advancement creates a dual-pathway approach alongside their oral formulation currently in Phase 1 trials.

The topical delivery mechanism offers potentially meaningful advantages through targeted pain relief with minimal systemic exposure - addressing a critical gap in current treatment options. Existing treatments (NSAIDs, lidocaine, capsaicin, anticonvulsants, and opioids) present significant limitations including minimal effectiveness, systemic side effects, or addiction risks.

This development substantially broadens Ketamir-2's potential applications across multiple high-value indications including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced neuropathy, osteoarthritis, and various nerve compression syndromes - collectively representing substantial market opportunities.

From a clinical development perspective, MIRA is advancing multiple programs simultaneously: the oral Ketamir-2 Phase 1 trial continues with results expected this year, Phase 2a trials for diabetic neuropathy are planned by year-end, and preclinical studies for both PTSD applications and the new topical formulation are underway.

For a company with $16M market capitalization, this pipeline expansion creates significant optionality and potential partnership opportunities, though investors should note the extended timeline with first efficacy data in humans not expected until Q1 2026.

Biotech Investment Analyst

MIRA's expansion into topical applications of Ketamir-2 represents a strategic pipeline diversification that significantly enhances their commercial positioning in the pain management sector. By pursuing dual formulation paths, MIRA has effectively doubled their shots on goal while targeting complementary market segments.

The topical delivery approach directly addresses major limitations in current treatments while potentially offering a preferred administration route for localized conditions. This creates a differentiated product profile in a market lacking innovation, particularly for conditions where systemic side effects limit treatment adherence.

The ongoing animal studies for the topical formulation, alongside progress in the oral Ketamir-2 Phase 1 trial, indicate proper resource allocation across multiple development pathways. The planned progression to Phase 2a in diabetic neuropathy by year-end establishes a clear clinical milestone that will provide the first efficacy signals for this compound.

For context, the global neuropathic pain market exceeds $5 billion annually with substantial growth projected due to increasing prevalence of diabetes, cancer treatments, and aging demographics. The inflammatory pain segment represents an even larger opportunity.

This development effectively transitions MIRA from a single-product company to a multi-product, multi-indication pipeline company, creating multiple potential value inflection points through 2025-2026. However, investors should note the extended commercialization timeline typical of CNS therapeutics and potential future capital requirements to support the expanded development program.

MIAMI, FL / ACCESS Newswire / March 13, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the successful formulation of Ketamir-2 into a topical treatment for localized neuropathic and inflammatory pain. This advancement expands the Company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain, offering a novel, targeted approach for localized pain relief.

"The development of both an oral and topical formulation of Ketamir-2 significantly expands our pipeline and enhances the value proposition of MIRA," stated Erez Aminov, Chairman and CEO of MIRA. "By advancing two distinct formulations, we are positioning Ketamir-2 to address multiple pain conditions and broaden its potential applications. This strategic approach strengthens our presence in the pain management space and underscores our commitment to delivering innovative solutions while creating value for our shareholders."

Expanding Therapeutic Potential with Topical Ketamir-2

The topical treatment of Ketamir-2 is designed for slow release, delivering targeted pain relief directly at the application site while minimizing systemic exposure and side effects. By offering localized relief, topical Ketamir-2 has the potential to transform the treatment landscape for neuropathic and inflammatory pain conditions, which currently lack effective long-term solutions.

Potential applications include:

• Neuropathic Pain Conditions - Covers diabetic neuropathy, postherpetic neuralgia (shingles-related pain), chemotherapy-induced peripheral neuropathy (CIPN), and complex regional pain syndrome (CRPS)-all of which cause chronic nerve pain and significantly impact quality of life.

• Inflammatory Pain Conditions - Includes osteoarthritis and rheumatoid arthritis, affecting millions of people worldwide and contributing to long-term disability and reduced mobility.

• Nerve Compression & Musculoskeletal Pain - Addresses conditions like carpal tunnel syndrome, sciatica, and anterior cutaneous nerve entrapment syndrome (ACNES), which result in localized nerve pain due to compression, inflammation, or injury.

Addressing Limitations of Current Pain Treatments

Current treatment options for localized neuropathic and inflammatory pain-including NSAIDs, lidocaine patches, capsaicin creams, gabapentin, pregabalin, and opioids-offer limited relief and come with significant side effects:

• NSAIDs & Over-the-Counter Topicals - Provide minimal relief for nerve pain and can cause skin irritation and gastrointestinal issues.

• Anticonvulsants & Antidepressants (Gabapentin, Pregabalin, Duloxetine) - Frequently prescribed but associated with dizziness, sedation, and cognitive impairment.

• Opioids - Highly addictive with severe dependency risks, making them unsuitable for long-term pain management.

"One of the biggest challenges in treating neuropathic pain is the lack of safe, effective, and targeted therapies," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Many current treatments either fail to provide adequate relief or come with serious side effects, limiting their long-term use. Ketamir-2's topical treatment has the potential to overcome these issues by delivering localized pain relief without the systemic side effects seen with oral medications. This could represent a significant advancement in neuropathic pain management."

Unlike existing treatments-such as NSAIDs, lidocaine patches, capsaicin creams, and systemic painkillers-topical Ketamir-2 aims to provide effective, long-lasting relief without the risks of systemic side effects, sedation, or opioid dependency. This innovative formulation builds on its unique mechanism of action and on research into topical ketamine, which has been used in compounded pain creams but lacks the bioavailability, consistency, and targeted action of Ketamir-2's novel design.

Advancing Clinical and Preclinical Programs

MIRA is actively advancing one clinical program and multiple preclinical programs, with significant milestones anticipated this year:

• Phase 1 Clinical Trial Progressing Smoothly - The ongoing Phase 1 study for the Ketamir-2 oral treatment for neuropathic pain is advancing as planned, with full results anticipated later this year.

• PTSD Studies Underway - Preclinical studies are investigating Ketamir-2's potential in treating PTSD, further expanding the drug's neuropsychiatric applications.

• Phase 2a for Diabetic Neuropathy Expected to Begin by Year-End - Preparations are underway for a Phase 2a study in diabetic neuropathy patients, with first human efficacy data expected by Q1 2026.

• Ongoing Animal Study for Topical Ketamir-2 in Inflammatory Pain - A preclinical study is currently assessing the efficacy of the new topical formulation in treating inflammatory pain, further expanding its potential applications as a topical agent for chronic pain conditions.

• MIRA-55 for Memory Enhancement - Continued preclinical studies are evaluating MIRA-55's potential cognitive benefits, with results expected to support future clinical development.

Conclusion

The successful development of both an oral and topical formulation of Ketamir-2 represents a significant step in broadening MIRA's pain management pipeline. By pursuing multiple formulations, the Company is working to expand the potential applications of Ketamir-2 while strategically positioning itself in the pain therapeutics market. As MIRA advances toward key clinical milestones, this approach reflects its commitment to innovation and long-term growth.

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

View the original press release on ACCESS Newswire

FAQ

What are the key advantages of MIRA's new topical Ketamir-2 formulation?

The topical Ketamir-2 offers targeted pain relief with minimal systemic exposure, slow release mechanism, and reduced side effects compared to traditional treatments.

When will MIRA Pharmaceuticals begin Phase 2a trials for diabetic neuropathy?

MIRA plans to begin Phase 2a trials for diabetic neuropathy by end of 2025, with first human efficacy data expected by Q1 2026.

What conditions can MIRA's topical Ketamir-2 potentially treat?

It targets neuropathic pain (diabetic neuropathy, postherpetic neuralgia), inflammatory pain (arthritis), and nerve compression conditions (carpal tunnel, sciatica).

How does MIRA's Ketamir-2 differ from existing pain treatments?

Unlike NSAIDs, lidocaine patches, and opioids, Ketamir-2 aims to provide effective long-term relief without systemic side effects, sedation, or dependency risks.

What clinical programs is MIRA currently advancing for Ketamir-2?

MIRA is conducting Phase 1 trials for oral Ketamir-2, preclinical studies for PTSD, and animal studies for the topical formulation.