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Mira Pharmaceuticals , Inc. (NASDAQ:MIRA), a development-stage pharmaceutical company with a market capitalization of $27.71 million, announced Tuesday the completion of the single ascending dose (SAD) portion of its Phase 1 clinical trial evaluating oral Ketamir-2 in healthy adult volunteers. According to a press release statement and a filing with the Securities and Exchange Commission, no severe or clinically significant adverse effects were observed at any dose level in the SAD phase. InvestingPro analysis shows the company maintains strong liquidity with a current ratio of 2.79, providing adequate resources for its clinical development programs.
The trial, conducted at the Hadassah Clinical Research Center in Israel under the supervision of Principal Investigator Prof. Yoseph Caraco, enrolled 32 participants. Subjects received single doses of Ketamir-2 ranging from 50 mg to 600 mg, divided into four cohorts. Dosing decisions were overseen by an independent Safety Steering Committee, which reviewed blinded safety and tolerability data before advancing to higher doses.
Safety monitoring during the trial included the Columbia-Suicide Severity Rating Scale (C-SSRS), Bowdle Visual Analogue Scale (VAS), and Ketamine Side Effect Tool (KSET) questionnaires.
With the SAD portion completed and no severe safety concerns reported, Mira Pharmaceuticals will proceed to the multiple ascending dose (MAD) stage of the trial. This stage will involve up to 24 participants in three cohorts, each receiving daily oral doses of 150 mg, 300 mg, or 600 mg of Ketamir-2 for five consecutive days. While the company’s stock has shown significant volatility with a beta of 1.79, InvestingPro data reveals it has gained nearly 28% over the past six months, reflecting investor optimism in its clinical progress. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better evaluate MIRA’s investment potential. The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of repeated administration of Ketamir-2 in healthy adults.
The company previously received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application for Ketamir-2 in neuropathic pain. Mira Pharmaceuticals stated it expects to initiate a U.S. Phase 2a clinical trial in the fourth quarter of 2025, subject to ongoing results and regulatory review. Based on InvestingPro’s Fair Value analysis, the stock appears slightly overvalued at its current price of $1.48, though investors should note that valuations for early-stage biotech companies often reflect future potential rather than current fundamentals.
All information is based on a press release statement and details disclosed in the company’s SEC filing.
In other recent news, MIRA Pharmaceuticals, Inc. announced that its lead oral drug candidate, Ketamir-2, has shown promising results in treating neuropathic pain. The study, accepted for publication in Frontiers in Pharmacology, revealed that Ketamir-2 outperformed ketamine, pregabalin, and gabapentin in restoring sensory function and reversing pain behaviors in rodent models. Additionally, the topical version of Ketamir-2 demonstrated pain relief comparable to injected morphine in preclinical animal testing. The U.S. Food and Drug Administration has cleared MIRA’s Investigational New Drug application for Ketamir-2, and the company is nearing completion of a Phase 1 trial at Hadassah Medical (TASE:BLWV) Center in Jerusalem. MIRA plans to initiate a U.S.-based Phase 2a clinical trial for Ketamir-2 in the fourth quarter of 2025. In another development, MIRA’s obesity and nicotine addiction drug candidate, SKNY-1, has shown anti-anxiety effects in preclinical studies. The study found that SKNY-1 significantly reversed anxiety-related behavior in animal models. This drug candidate is under a definitive agreement for acquisition, as reported in an SEC filing.
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