The Fort Worth Press - MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study

MIAMI, FLORIDA / ACCESS Newswire / July 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data showing that its topical Ketamir-2 cream delivered similar and consistent pain relief compared with injected morphine in a validated animal model of acute and inflammatory pain.

In the study, Ketamir-2 cream was applied topically to the affected area 30 minutes before pain was induced using the formalin model, a widely accepted preclinical method for evaluating both acute and inflammatory pain. In this model, a small amount of formalin (a dilute formaldehyde solution) is injected into the paw, producing two well-characterized phases of pain: an initial acute phase driven by direct nerve activation, followed by a prolonged inflammatory phase associated with central sensitization (a mechanism shared with neuropathic pain). Researchers monitored spontaneous pain-related behaviors-specifically paw licking and paw lifting-using AI-assisted video analysis of 5-minute slots over a 60-minute period.

Topical Ketamir-2 was effective as Injected morphine in both phases, nearly eliminating pain behaviors during the acute phase and maintaining a strong, durable effect throughout the inflammatory phase. These results indicate Ketamir-2's potential to modulate both peripheral and central pain pathways with topical, localized delivery.

"These findings confirm Ketamir-2's potential as a next-generation, non-opioid topical treatment for localized pain," said Erez Aminov, Chairman and CEO of MIRA. "With our oral IND already cleared and a Phase 2a neuropathic pain trial expected to begin by year-end, this topical data meaningfully expands our clinical and commercial strategy. We're advancing a dual-route platform that can target both systemic and localized pain conditions-offering optionality for patients and value for shareholders."

Dual-Phase Pain Relief Without Systemic Burden

Unlike systemic analgesics, which circulate throughout the body and may cause unwanted side effects, Ketamir-2's topical formulation is designed to provide direct, localized pain relief with minimal systemic exposure. Its performance across both acute and inflammatory pain phases supports a broad therapeutic profile-potentially applicable to conditions such as diabetic neuropathy, chemotherapy-induced peripheral neuropathy (CIPN), postherpetic neuralgia, and osteoarthritis.

"What's remarkable is Ketamir-2's ability to nearly abolish acute pain behavior while also suppressing inflammation-driven responses," said Dr. Itzchak Angel, CSA at MIRA. "This dual-phase efficacy is rarely seen with topicals and strongly supports our rationale to continue advancing preclinical studies aimed at treating complex localized pain conditions."

Addressing an $11.5 Billion U.S. Topical Pain Market

The U.S. topical pain relief market is projected to exceed $11.5 billion by 2025, driven by demand for safer, non-opioid, non-systemic options, according to a report by Research and Markets. Chronic pain affects more than 51 million adults in the U.S., and many of the most prevalent pain conditions-such as osteoarthritis and neuropathy-are localized in nature.

Ketamir-2's topical formulation is designed to meet this need by offering:

• Fast onset of action

• Efficacy in both neurogenic and inflammatory pain

• Minimal systemic absorption

• Non-opioid, non-habit forming mechanism of action

Unlike many pain programs that pursue either systemic or localized delivery, MIRA is developing Ketamir-2 in both oral and topical forms. This dual-path approach may enable clinical evaluation across a broader spectrum of pain conditions-ranging from widespread neuropathic syndromes to localized inflammatory pain. If successful, this strategy could support differentiated product profiles and expand potential treatment opportunities.

A Scalable Non-Opioid Pain Platform

MIRA is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers. Following FDA clearance of its Investigational New Drug (IND) application, a Phase 2a clinical trial in neuropathic pain is expected to begin later this year in the USA.

The Company is also continuing preclinical development of the topical formulation to further characterize its pharmacological effects and support potential clinical advancement. Together, these efforts reflect a platform strategy designed to address high-burden pain conditions through both systemic and localized approaches.

"As we continue to execute on our clinical and regulatory milestones, we remain focused on unlocking the full value of the Ketamir-2 platform-either through internal advancement or strategic partnership," added Aminov.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's 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. Any forward-looking statements in this press release are based on MIRA'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 MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Helga Moya
[email protected]
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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C.Rojas--TFWP