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.

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.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Krystina Quintana
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

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