Topical Ketamir-2 shows pain relief comparable to morphine in study

MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company with a market capitalization of $30.66 million, announced Wednesday that its topical Ketamir-2 cream demonstrated pain relief comparable to injected morphine in preclinical animal testing of both acute and inflammatory pain. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 12.86, providing ample resources for its development programs.

In the study, Ketamir-2 was applied to the affected area 30 minutes before pain was induced using the formalin model, a widely used preclinical method for evaluating pain responses. Researchers monitored pain-related behaviors using AI-assisted video analysis over a 60-minute period.

The topical treatment showed effectiveness nearly equivalent to injected morphine in both the acute phase, which involves direct nerve activation, and the inflammatory phase associated with central sensitization. The company reported that Ketamir-2 nearly eliminated pain behaviors during the acute phase while maintaining a strong effect throughout the inflammatory phase.

"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, according to the press release.

Unlike systemic pain medications that circulate throughout the body, the topical formulation is designed to provide localized relief with minimal systemic exposure. The company suggests potential applications could include diabetic neuropathy, chemotherapy-induced peripheral neuropathy, postherpetic neuralgia, and osteoarthritis.

MIRA is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers and expects to begin a Phase 2a clinical trial in neuropathic pain later this year following FDA clearance of its Investigational New Drug application.

The company is developing Ketamir-2 in both oral and topical forms, pursuing a dual-path approach that could potentially address both widespread neuropathic syndromes and localized inflammatory pain conditions. While InvestingPro analysis indicates analysts don’t expect profitability this year, with a forecasted EPS of -$0.46, the company’s stock has shown strong momentum with a 31.75% return over the past six months.

The U.S. topical pain relief market is projected to exceed $11.5 billion by 2025, according to data cited in the company’s statement. MIRA’s stock currently trades near $1.69, and InvestingPro subscribers have access to 7 additional key insights about the company’s valuation and growth prospects, along with real-time financial metrics and expert analysis.

In other recent news, MIRA Pharmaceuticals has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for Ketamir-2, which is being developed to treat neuropathic pain. The company is currently conducting a Phase 1 trial in Jerusalem and plans to start a U.S.-based Phase 2a clinical trial by the fourth quarter of 2025. Additionally, MIRA reported promising preclinical results for its drug candidate SKNY-1, which is under a definitive agreement for acquisition. SKNY-1, aimed at treating obesity and nicotine addiction, showed a reversal of anxiety-related behavior in animal models.

In financial developments, MIRA Pharmaceuticals raised approximately $2 million through an at-the-market stock sale, selling over 1.5 million shares to an institutional investor. This transaction was facilitated by Rodman & Renshaw using the StockBlock platform. Moreover, MIRA announced positive preclinical data for its non-opioid pain drug, Mira-55, which demonstrated pain relief comparable to morphine without causing local inflammation. Mira-55 is designed to selectively activate CB2 cannabinoid receptors, reducing pain sensitivity significantly in preclinical models. These developments indicate ongoing advancements in MIRA’s drug pipeline and financial activities.

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