MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies
Building on Proven Pain Relief Data
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.
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.
A Next-Generation Cannabinoid Analog
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.
Cannabinoid therapies that significantly activate CB1 receptors have historically been associated with central nervous system effects, including psychoactivity and psychiatric adverse events.
IND Strategy and Market Opportunity
MIRA is advancing Mira-55 toward regulatory IND-enabling studies for inflammatory pain, an area with significant unmet medical need. Current treatment options include: Opioids, which are associated with risks of dependence, tolerance, and overdose; nonsteroidal anti-inflammatory drugs (NSAIDs), which may cause gastrointestinal, renal, and cardiovascular adverse effects. Mira-55 is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing CB1-related psychoactivity.
MIRA-55 is not extracted from the cannabis plant but is synthesized, allowing for a precise and novel chemical structure that separates it from known, controlled cannabinoids. Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance.
According to Grand View Research (2024), the global non-opioid pain treatment market was estimated at approximately $45.3 billion in 2024 and is projected to reach $70.3 billion by 2030, growing at a compound annual growth rate (CAGR) of 7.7%.
