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MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a clinical-stage pharmaceutical company with a market capitalization of $19.67 million, has announced successful results from a neurotoxicity study of Ketamir-2, a novel oral NMDA receptor antagonist. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.99, indicating robust short-term financial stability. The study, a prerequisite by the U.S. Food and Drug Administration (FDA) for human dosing, revealed no signs of brain toxicity, including the absence of Olney lesions, which are brain changes previously associated with NMDA-targeting drugs like ketamine. While the clinical results are promising, InvestingPro analysis shows the company is not yet profitable, with analysts anticipating continued development-stage expenses through this year.
The preclinical study involved the administration of high oral doses of Ketamir-2 to sexually mature Sprague-Dawley rats, with a positive control group receiving MK-801, a known neurotoxic NMDA receptor antagonist. The results showed no adverse clinical signs or mortality in any Ketamir-2-treated animals, and no brain lesions were detected at any dose level. In contrast, MK-801-treated animals did exhibit clear evidence of brain toxicity.
Ketamir-2 stands out as a New Molecular Entity (NME) designed to modulate the NMDA receptor, reducing affinity for the PCP binding site associated with neurotoxicity and psychotropic effects. Previous preclinical studies have demonstrated Ketamir-2’s effectiveness in reversing pain thresholds in neuropathic pain models, outperforming approved treatments such as gabapentin and pregabalin, without causing sedation or hyperactivity. Its strong oral bioavailability and brain penetration, along with the U.S. Drug Enforcement Administration’s (DEA) determination that it is not a controlled substance, position Ketamir-2 as a promising candidate for CNS disorders.
MIRA has initiated Phase I clinical trial enrollment and is preparing for a Phase IIa proof-of-concept trial in diabetic patients with neuropathic pain. The neurotoxicity study results will be submitted to the FDA as part of the company’s ongoing regulatory and clinical development strategy. With the next earnings report due in 22 days and analysts setting a significantly higher target price, investors seeking detailed financial analysis and additional insights can access more than 8 exclusive ProTips through InvestingPro’s comprehensive coverage.
This information is based on a press release statement from MIRA Pharmaceuticals. The company has cautioned that this press release contains forward-looking statements that are subject to risks and uncertainties which could cause actual results to differ materially from those projected.
In other recent news, MIRA Pharmaceuticals, Inc. announced the successful completion of in vitro release testing for its Ketamir-2 topical formulation, marking a significant advancement in its drug development program. The study demonstrated a consistent and dose-proportional release, adhering to FDA guidelines, and suggests potential as a non-opioid pain treatment. Additionally, MIRA’s oral Ketamir-2 formulation has shown significant efficacy in an animal model of diabetic neuropathy, with plans to initiate a Phase IIa trial by the end of 2025. The company is also exploring Fast Track designation for the topical Ketamir-2 program under the FDA’s expedited development program. In other developments, MIRA Pharmaceuticals received a notification from Nasdaq regarding non-compliance with the minimum stockholders’ equity requirement for continued listing. The company is actively working on a compliance plan, including the completion of a pending acquisition of SKNY Pharmaceuticals, Inc., which is expected to infuse $5 million in capital. MIRA remains optimistic about addressing the shortfall and maintaining its Nasdaq listing.
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