MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies

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.

Leadership Commentary

"The challenge in cannabinoid drug development has never been the biology-it's been separating it from CNS side effects. We believe Mira-55 may represent an important step in that direction as we advance toward clinical development in inflammatory pain."
- Erez Aminov, Chairman and CEO of MIRA

Dr. Itzchak Angel, Chief Scientific Advisor, added:
"The consistency observed across multiple validated behavioral assays supports Mira-55's differentiated pharmacological profile and its separation from known CB1-related effects."

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

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%.

About Mira-55

Mira-55 is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing CB1-related psychoactivity. Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company focused on the development of novel therapies for neurologic, neuropsychiatric, and metabolic disorders. Its pipeline includes Mira-55 for inflammatory pain, Ketamir-2 for neuropathic pain, and SKNY-1 targeting obesity and smoking cessation. The Company is headquartered in Miami, Florida.

Leadership Commentary

SOURCE: MIRA Pharmaceuticals