MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) on Wednesday released data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy, a type of nerve damage that can occur in diabetes patients. 

In the study, Type 2 diabetes was induced in rats using a high-fat diet combined with a low dose of Streptozotocin (STZ).

Treatment with Ketamir-2 led to a significant reduction in neuropathic pain symptoms, with some animals returning completely to pre-diabetic baseline sensitivity.

• 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, demonstrating a favorable safety profile.
• Unlike traditional ketamine, Ketamir-2 does not induce dissociative or psychedelic effects and is not a substrate for P-glycoprotein, allowing for more efficient penetration across the blood-brain barrier.

Also Read: EXCLUSIVE: MIRA Pharmaceuticals Expands Pipeline, Enhances Value Proposition With Development Of Topical Formulation For Lead Pain Treatment Candidate

Diabetic neuropathy affects between 28% to 55% of patients with diabetes.

Current treatment options are limited, with first-line therapies such as pregabalin, gabapentin, and duloxetine often delivering only modest symptom relief. These drugs are frequently associated with side effects such as dizziness, fatigue, cognitive impairment, and gastrointestinal discomfort. Up to 50% of patients fail to achieve meaningful pain reduction.

At the same time, the demand for non-opioid therapies is growing rapidly, driven by the ongoing opioid crisis and heightened regulatory scrutiny. Ketamir-2's non-addictive profile and lack of dissociative side effects position it as a strong candidate in this emerging treatment landscape.

MIRA anticipates initiating its Phase 2a trial in diabetic neuropathy by the end of 2025, with the first human efficacy data expected in the first half of 2026.

In parallel, the company is developing a topical slow-release formulation of Ketamir-2 to provide localized pain relief with minimized systemic exposure.

In addition, MIRA is actively conducting ongoing studies assessing the efficacy of Ketamir-2 in models of post-traumatic stress disorder.

In March, MIRA Pharmaceuticals signed a binding letter of intent to acquire SKNY Pharmaceuticals, Inc.

The transaction includes a $5 million capital infusion of cash or equivalent consideration into MIRA, reinforcing its financial position and supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight loss and smoking cessation.

Price Action: MIRA stock closed at $0.89 on Tuesday.

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This article EXCLUSIVE: MIRA Pharmaceuticals Ketamir-2 Shows Efficacy In Diabetes-Associated Nerve Damage In Animal Study originally appeared on Benzinga.com

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