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MIAMI – MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a micro-cap biotech company ($15.09M market cap) specializing in treatments for neurological and neuropsychiatric disorders, announced today that its oral ketamine analog, Ketamir-2, has shown significant efficacy in an animal model of diabetic neuropathy. According to InvestingPro analysis, MIRA maintains a strong liquidity position with more cash than debt, though the stock currently trades at a premium valuation with a Price/Book ratio of 6.8x. In a recent study, the treatment led to a marked reduction in neuropathic pain symptoms, even returning some animals to their pre-diabetic sensitivity levels.
The study, which induced Type 2 diabetes in rats to mimic human diabetic pathology, used a high-fat diet and a low dose of Streptozotocin (STZ), resulting in hyperglycemia and neuropathic symptoms such as hyperalgesia and allodynia. By the eighth week, most diabetic rats showed sensory hypersensitivity, which was notably alleviated by Ketamir-2. The company’s stock has shown volatility, with a 52-week range of $0.51 to $5.01, reflecting the typical risk profile of early-stage biotech companies.
Erez Aminov, Chairman and CEO of MIRA, expressed optimism about Ketamir-2 as a non-opioid alternative for the millions of patients with diabetic neuropathy, who currently have limited treatment options. MIRA is advancing its Phase I study and plans to initiate a Phase IIa trial in patients by the end of 2025.
The company emphasized the alignment between the animal model and human pathology, suggesting a high degree of scientific confidence moving forward. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, highlighted the robust responses in the model and the guidance it provides for future clinical development.
Diabetic neuropathy, a prevalent complication of diabetes, affects up to 55% of diabetic patients and contributes significantly to the economic burden on healthcare systems. Current treatment options offer only modest relief and come with side effects such as dizziness, fatigue, and gastrointestinal discomfort. Up to half of the patients do not achieve meaningful pain reduction, underlining the urgent need for more effective alternatives.
Ketamir-2’s development is further encouraged by the FDA’s identification of neuropathic pain as a high-priority area for accelerated development pathways. MIRA anticipates first human efficacy data from its Phase IIa trial in the first half of 2026 and is also exploring Ketamir-2’s potential in treating PTSD and other conditions.
This news is based on a press release statement from MIRA Pharmaceuticals. While analysts have set an ambitious target price of $17.75, InvestingPro data reveals the company faces near-term profitability challenges, with forecasted negative earnings for the current fiscal year. Investors seeking deeper insights into MIRA’s financial health and growth prospects can access additional ProTips and comprehensive analysis through an InvestingPro subscription.
In other recent news, MIRA Pharmaceuticals announced significant findings from a preclinical study of its drug candidate, Ketamir-2, which showed a notable reduction in neuropathic pain symptoms in an animal model of diabetic neuropathy. The company has also commenced its Phase 1 clinical trial for Ketamir-2, enrolling participants in a study set to evaluate the drug’s safety and effectiveness. Meanwhile, MIRA Pharmaceuticals is facing a potential Nasdaq delisting due to not meeting the minimum stockholders’ equity requirement, though it is actively working on a compliance plan. Part of this plan includes the pending acquisition of SKNY Pharmaceuticals, which is expected to infuse $5 million in capital into MIRA.
The acquisition of SKNY Pharmaceuticals is a strategic move to expand MIRA’s therapeutic pipeline, particularly with SKNY-1, a drug candidate targeting obesity and smoking cessation. This acquisition involves a stock exchange and a capital infusion from SKNY, contingent upon shareholder and regulatory approvals. In addition, MIRA Pharmaceuticals continues to focus on its neuroscience pipeline and has expressed optimism about the prospects of SKNY-1. These developments mark a period of significant activity for MIRA Pharmaceuticals as it navigates both scientific advancements and financial challenges.
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