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Item 8.01 Other Events
MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study
Topical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases
On July 29, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced preclinical data evaluating the analgesic effects of its new topical Ketamir-2 formulation in a validated rodent model of pain. The study was designed to assess spontaneous pain-related behaviors in response to formalin injection, a well-established method that induces a biphasic pain response: an acute phase (0–10 minutes) driven by direct nociceptor activation, and an inflammatory phase (15–60 minutes) driven by central sensitization.
Topical Ketamir-2 cream formulation was applied to the injected area at 30 minutes and just prior to formalin administration. Behavioral analysis was conducted over five-minutes intervals on a 60-minute period using AI-assisted video tracking to quantify two validated endpoints:
| ● | Paw licking, an active response associated with pain severity. | |
| ● | Paw lifting, a passive avoidance behavior associated with pain discomfort. |
Study Results:
| ● | In Phase 1 (0–10 min), Topical Ketamir-2 treatment nearly eliminated paw licking and significantly and markedly reduced paw lifting compared to formalin-only control and was similar to morphine-treated animals. | |
| ● | In Phase 2 (15–60 min), Topical Ketamir-2 continued to show significant reduction in both behaviors, with comparable overall suppression as morphine. | |
| ● | Effect sizes were consistent across all 5-minute intervals throughout the study duration. |
The formalin test is commonly used to evaluate potential analgesic agents that target both neurogenic and inflammatory pain mechanisms. Phase 2 of the model, in particular, reflects central sensitization, a hallmark of many chronic and neuropathic pain conditions.
The Company is currently conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers and expects to begin a Phase 2a study in neuropathic pain later in 2025. MIRA is also continuing preclinical development of the topical formulation, including additional pharmacological and toxicological assessments.
This preclinical study supports continued investigation of topical Ketamir-2 as a potential non-opioid treatment for localized pain conditions, including diabetic neuropathy, postherpetic neuralgia, chemotherapy-induced peripheral neuropathy, osteoarthritis, and other forms of inflammatory pain.
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: July 29, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |