Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain
MIAMI, FL / ACCESS Newswire / March 23, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, today announced new preclinical data demonstrating that Mira-55 did not produce cannabinoid-like central nervous system (CNS) side effects across a comprehensive battery of validated behavioral assays. The observed profile was differentiated from both Δ9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis, and the CB1 receptor antagonist rimonabant.
These findings build on previously reported preclinical data demonstrating that Mira-55 delivered morphine-comparable pain relief in a validated model of inflammatory pain, without opioid-related risks. Collectively, these data support the Company's ongoing efforts to advance Mira-55 toward an Investigational New Drug (IND) submission for inflammatory pain.
Study Overview and Key Findings
The study, conducted in collaboration with Pharmaseed, evaluated Mira-55 at oral doses of 10, 30, and 100 mg/kg and compared its behavioral effects to THC and rimonabant using established assays commonly employed to assess cannabinoid-related CNS and behavioral effects, including:
Hypothermia
Catalepsy
Elevated Plus Maze (EPM)
Open Field (OF)
Key Observations:
No cannabinoid-like psychogenic effects were observed at any tested dose of Mira-55
No evidence of sedation, catalepsy, or motor impairment, differentiating Mira-55 from CB1-active compounds such as rimonabant
No anxiogenic effects were observed, in contrast to rimonabant, which demonstrated anxiety-like behavioral changes
In the Elevated Plus Maze (EPM), Mira-55 showed a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior
In Open Field testing, Mira-55-treated groups were comparable to vehicle controls, indicating no detectable adverse behavioral effects. Rimonabant-treated groups demonstrated reduced time spent in the center of the open field, a commonly used indicator of anxiety-like behavior, supporting the sensitivity of the experimental model.
Integrated Preclinical Profile
The CNS safety findings complement previously reported preclinical efficacy data demonstrating that Mira-55:
Reduced pain sensitivity and restored thresholds to near-baseline levels in inflammatory pain models
Demonstrated morphine-comparable analgesic effects in a validated inflammatory pain model
Did not produce sedation or opioid-like adverse effects
Did not induce inflammatory swelling, supporting a differentiated profile versus certain comparator agents
While these findings are based on preclinical models, they support a differentiated pharmacological profile for Mira-55.
Differentiation from THC and Historical Cannabinoid Therapies
Cannabinoid therapies that significantly activate CB1 receptors have historically been associated with central nervous system effects, including psychoactivity and psychiatric adverse events.
Mira-55 is a next-generation cannabinoid analog designed to modulate CB1 and CB2 receptor activity while minimizing CB1-mediated central nervous system effects. This differentiated pharmacological profile may enable therapeutic activity without the CNS liabilities that have historically limited cannabinoid-based drug development.