MIRA Pharmaceuticals (NASDAQ:MIRA), a clinical-stage company focused on developing new treatments for neurologic and neuropsychiatric disorders, today shared positive outcomes from a preclinical study evaluating its oral ketamine analog, Ketamir-2.
The study investigated the drug's potential in treating diabetic neuropathy using a validated animal model.
The research utilized a well-established rat model designed to mimic type 2 diabetes and its complications.
Rats were subjected to a high-fat diet combined with low doses of Streptozotocin (STZ), leading to insulin resistance, high blood sugar levels, and reduced pancreatic function.
Within eight weeks, most animals developed neuropathic pain, characterized by hyperalgesia (increased sensitivity to pain) and allodynia (pain from non-painful stimuli), which was confirmed using mechanical sensitivity tests.
Results showed that animals receiving oral doses of Ketamir-2 experienced a statistically significant decrease in neuropathic pain symptoms compared to the untreated control group.
Significantly, some treated animals even reverted to their pre-diabetic baseline sensitivity levels, suggesting a complete resolution of symptoms in those cases.
These findings indicate Ketamir-2's potential to reverse pain-related hypersensitivity associated with diabetic neuropathy.
This study builds upon previous preclinical research that demonstrated Ketamir-2's effectiveness, oral bioavailability (ability to be absorbed when taken by mouth), and a favorable profile lacking the dissociative side effects often associated with ketamine.
The positive preclinical data supports MIRA Pharmaceuticals' ongoing Phase I clinical trial assessing Ketamir-2 in healthy volunteers.
The company plans to initiate a Phase IIa clinical trial specifically for patients with diabetic neuropathy by the end of 2025.