The study, conducted in collaboration with Pharmaseed, involved administering oral doses of Mira-55 at 10, 30, and 100 mg/kg, with comparisons made to Δ9-tetrahydrocannabinol (THC) and the CB1 receptor antagonist rimonabant. The assessments included various behavioral assays such as hypothermia, catalepsy, Elevated Plus Maze (EPM), and Open Field (OF) tests, which are standard for evaluating cannabinoid-related side effects.
Key findings from the study revealed that:
- Mira-55 did not induce any psychogenic effects, sedation, catalepsy, or motor impairment at any dose.
- Unlike rimonabant, which exhibited anxiety-like behavioral changes, Mira-55 showed no anxiogenic effects.
- In the EPM, Mira-55 demonstrated a dose-dependent increase in time spent in open arms, indicating reduced anxiety-like behavior.
- Open Field testing showed that Mira-55-treated groups performed comparably to vehicle controls, while rimonabant-treated groups exhibited reduced time in the center, a common indicator of anxiety-like behavior.
These findings build upon previously reported data that demonstrated Mira-55's ability to provide significant analgesic effects in inflammatory pain models, effectively reducing pain sensitivity and restoring thresholds to near baseline levels without the risks associated with opioid use. MIRA Pharmaceuticals is advancing Mira-55 towards an IND submission, aiming to address the growing need for safe and effective pain management solutions. The company continues to conduct additional preclinical studies to support potential future clinical development.