MIRA Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
MIRA Pharmaceuticals Announces Positive Study Results for Ketamir-2 in Diabetic Neuropathy Model
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced positive results from a preclinical study evaluating its oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.
The study was conducted using a well-established rat model of type 2 diabetes, combining a high-fat diet with low-dose Streptozotocin (STZ) to induce insulin resistance, hyperglycemia, and a significant reduction in pancreatic β-cell function. By week 8 following induction, most of the animals developed neuropathic pain expressed as hyperalgesia and allodynia, confirmed experimentally through mechanical hypersensitivity assessments using von Frey filaments.
Animals treated orally with Ketamir-2 exhibited a statistically significant reduction in neuropathic pain symptoms compared to untreated controls. Notably, a subset of treated animals returned to pre-diabetic baseline sensitivity levels, indicating full symptom resolution in those cases. These results highlight the compound’s potential to reverse pain-related hypersensitivity in diabetic neuropathy.
The study reinforces prior preclinical findings in other experimental models demonstrating Ketamir-2’s efficacy, oral bioavailability, and non-dissociative profile. These findings support MIRA’s ongoing Phase I clinical trial in healthy volunteers and its plan to initiate a Phase IIa trial in diabetic neuropathy patients by the end of 2025.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | |||
| Dated: | April 16, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | ||
| Title: | Chief Executive Officer | ||