MIRA Pharmaceuticals Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
On July 2, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced preclinical results demonstrating that its proprietary drug candidate, Mira-55, a non-psychoactive marijuana analog, delivered morphine-comparable pain relief in a validated animal model of inflammatory pain, without inducing local inflammation.
Mira-55 is a synthetic analog of marijuana engineered to selectively activate CB2 receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, it exhibits minimal activity at CB1 receptors, thus avoiding psychoactive side effects. In a formalin-based rodent model, Mira-55 significantly reduced pain sensitivity, restored pain thresholds to near-baseline levels, and showed efficacy comparable to morphine, the opioid control. No sedative or inflammatory effects were observed.
In addition, the Company previously received confirmation from the U.S. Drug Enforcement Administration (DEA) that Mira-55 is not classified as a controlled substance, removing a key regulatory barrier to clinical development.
These new results strengthen MIRA’s pain-focused pipeline by positioning Mira-55 as a complementary program to Ketamir-2, the Company’s clinical-stage NMDA receptor antagonist currently progressing through Phase 1 development for neuropathic pain.
“With Mira-55 and Ketamir-2, we believe we’re building a differentiated, non-opioid pain franchise with the potential to treat two of the largest and most underserved pain markets,” said Erez Aminov, Chairman and CEO of MIRA.
MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings—highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction.
MIRA continues to advance Mira-55 toward an Investigational New Drug (IND) submission, with development efforts supporting future clinical trials in inflammatory pain indications.
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 2, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |