MIRA's Mira-55 Shows No CNS Side Effects at Up to 100 mg/kg, Supports IND
MIRA Pharmaceuticals' preclinical evaluation of Mira-55 at 10, 30 and 100 mg/kg showed no THC-like CNS effects or sedation in hypothermia, catalepsy, elevated plus maze and open field assays. These results, combined with previously reported morphine-comparable pain relief without opioid risks, support a planned IND submission for inflammatory pain.
1. CNS Safety Assessment
MIRA evaluated Mira-55 orally at 10, 30 and 100 mg/kg in validated assays including hypothermia, catalepsy, elevated plus maze and open field testing. No cannabinoid-like psychogenic effects, sedation or motor impairment were observed, while rimonabant controls displayed anxiety-like behavior.
2. Differentiated Analgesic Profile
Prior studies showed Mira-55 delivered morphine-comparable analgesia in inflammatory pain models, restored pain thresholds without inducing sedation, inflammatory swelling or opioid-like adverse effects, highlighting a favorable efficacy and safety balance.
3. IND Submission Strategy
These preclinical safety and efficacy findings underpin MIRA’s plan to advance Mira-55 into IND-enabling studies targeting inflammatory pain, a non-opioid market estimated at $70.3 billion by 2030, with significant unmet need in pain management.