MIRA Pharmaceuticals reports Mira-55 shows no CNS side effects in studies

MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) announced preclinical data showing its drug candidate Mira-55 did not produce central nervous system side effects associated with cannabis compounds or certain cannabinoid receptor antagonists.

The study, conducted with Pharmaseed, tested Mira-55 at oral doses of 10, 30, and 100 mg/kg using behavioral assays including hypothermia, catalepsy, elevated plus maze, and open field tests. The compound showed no psychogenic effects, sedation, catalepsy, or motor impairment at any tested dose.

In elevated plus maze testing, Mira-55 demonstrated a dose-dependent increase in time spent in open arms, indicating reduced anxiety-like behavior. Open field testing showed Mira-55-treated groups performed comparably to vehicle controls, with no detectable adverse behavioral effects.

The results differentiated Mira-55 from THC, cannabis's primary psychoactive component, and rimonabant, a CB1 receptor antagonist that showed anxiety-like behavioral changes in the same tests.

Previous preclinical studies showed Mira-55 delivered pain relief comparable to morphine in inflammatory pain models without opioid-related risks. The company plans to use these combined findings to support an Investigational New Drug submission for inflammatory pain treatment.

"The challenge in cannabinoid drug development has never been the biology-it's been separating it from CNS side effects," said Erez Aminov, chairman and CEO of MIRA.

Mira-55 is designed as a cannabinoid analog that modulates CB1 and CB2 receptor activity while minimizing CB1-mediated central nervous system effects. The U.S. Drug Enforcement Administration determined the compound is not classified as a controlled substance.

The company cited Grand View Research data estimating the global non-opioid pain treatment market at $45.3 billion in 2024, projected to reach $70.3 billion by 2030.

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