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MIRA Pharmaceuticals Announces Positive Results for Ketamir-2 in Diabetic Neuropathy Animal Model, Reinforcing Confidence Ahead of Phase I Completion
Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical ...
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal","length":123,"tagName":"p"},{"type":"text","content":"MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.","length":381,"tagName":"p"},{"type":"text","content":"In the study, Type 2 diabetes was induced in rats using a high-fat diet combined with a low dose of Streptozotocin (STZ). This resulted in hyperglycemia and neuropathic symptoms, including hyperalgesia and allodynia, mimicking human diabetic pathology. By week 8, most diabetic rats exhibited sensory hypersensitivity. Treatment with Ketamir-2 led to a significant reduction in neuropathic pain symptoms, with some animals returning completely to pre-diabetic baseline sensitivity. "Millions of patients with diabetic neuropathy are left with limited, often ineffective treatment options," said Erez Aminov, Chairman and CEO of MIRA.","length":643,"tagName":"p"},{"type":"text","content":""With Ketamir-2, we're aiming to offer a non-opioid alternative that's not only safer but potentially more effective. We're currently advancing our Phase I study and plan to initiate a Phase IIa trial in diabetic neuropathy patients by year-end. Given that the FDA has designated neuropathic pain as a high-priority area for Fast Track and Breakthrough Therapy pathways, we believe Ketamir-2 is uniquely positioned to meet this urgent need and unlock significant clinical and commercial value."","length":516,"tagName":"p"},{"type":"text","content":"Translational Data Strengthens Clinical Momentum","length":48,"tagName":"p"},{"type":"text","content":"These results build upon prior preclinical studies using other neuropathy animal models, where orally administered Ketamir-2 outperformed FDA-approved neuropathic pain medications such as pregabalin and gabapentin, while also demonstrating a favorable safety profile. Unlike traditional ketamine, Ketamir-2 does not induce dissociative or psychedelic effects and is not a substrat...