MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain

Rhea-AI Summary

MIRA (NASDAQ:MIRA) announced preclinical results on October 16, 2025 showing that oral Mira-55 normalized pain thresholds and significantly reduced inflammation in a formalin-induced inflammatory pain animal model, outperforming injected morphine.

The study measured pain with Von Frey testing and inflammation via paw-edema volume, reporting direct CB2 receptor–mediated anti-inflammatory effects for Mira-55 versus partial, centrally mediated effects for morphine. Results support MIRA's plan to pursue an IND for chronic inflammatory pain and reinforce positioning in a projected non-opioid pain market valued at USD 70.3B by 2030.

Positive

• Oral Mira-55 normalized pain thresholds in animal model (Oct 16, 2025)
• Mira-55 significantly reduced inflammation via CB2-mediated mechanism
• Outperformed injected morphine on pain normalization in the study
• Supports company plan to pursue an IND for chronic inflammatory pain

Negative

• Results are preclinical only; no human clinical data reported
• No quantitative safety or toxicity data disclosed in this release
• IND pursuit is planned but not described as filed or approved

Insights

Translational pharmacology expert

Preclinical oral data show CB2-selective Mira-55 normalized pain and reduced inflammation, supporting planned IND.

Mira-55 showed full normalization of Von Frey withdrawal thresholds and significant reduction in paw-edema volume in a formalin inflammatory pain model, outperforming injected morphine on those measures. The program reports a direct CB2 receptor-mediated anti-inflammatory mechanism and analgesia with no reported sedation or opioid-related risks, and the company links this to plans for an IND.

The result depends on reproducibility, toxicology, and clinical translation; animal-model efficacy does not guarantee human safety or effect size. The release provides no GLP toxicology, PK, or IND timing details, so regulatory and clinical milestones remain the key risks.

Watch for an actual IND submission and subsequent early human pharmacokinetic, safety, and proof-of-concept results; these milestones will determine whether the preclinical advantage translates clinically. The market context cited: non-opioid pain market USD 45.3 billion in 2024, projected to USD 70.3 billion by 2030 at a 7.7% CAGR, which frames commercial potential if clinical validation occurs.

Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market.

MIAMI, FLORIDA / ACCESS Newswire / October 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders, announced new preclinical data showing that oral Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of inflammatory pain.

This study marks the first time inflammation was directly measured alongside pain in MIRA's Mira-55 program. In the Company's prior study, only pain sensitivity was evaluated, with both Mira-55 and morphine administered by injection. The new data expand those findings by demonstrating that oral administration of Mira-55 provided superior pain normalization and direct anti-inflammatory effects, whereas morphine produced only partial and indirect inflammation reduction.

Study Overview and Key Findings

Pain sensitivity was assessed using Von Frey Filament testing, and inflammation was quantified by paw-edema volume in the formalin-induced inflammatory pain model.

Results:

• Oral Mira-55 normalized pain thresholds, fully restoring withdrawal responses to baseline and outperformed injected morphine.

• Mira-55 significantly reduced inflammation, confirming a direct CB2 receptor-mediated anti-inflammatory mechanism, while morphine showed only partial, centrally mediated effects.

• Both treatments provided pain relief, but Mira-55 delivered dual anti-inflammatory and analgesic benefits without sedation or opioid-related risks.

These findings build on previously reported data showing that injected Mira-55 achieved morphine-comparable pain relief, while this new study demonstrates that oral Mira-55 achieved superior pain normalization and direct inflammation reduction. Collectively, the results reinforce Mira-55's potential as a dual-acting, non-opioid therapy that addresses both inflammation and pain through differentiated, CB2-selective mechanisms.

Reducing inflammation is fundamental to treating pain effectively. Inflammation drives the heightened sensitivity of pain-sensing nerves, amplifying pain signals. Traditional opioids only block pain perception in the brain and do not address inflammation, while NSAIDs treat inflammation but carry significant safety risks. By directly targeting inflammation through CB2 receptor activation, Mira-55 addresses both the cause and the perception of pain, offering a differentiated approach that could redefine how chronic inflammation-driven pain is managed.

Leadership Commentary

"These results highlight the strength of our pipeline and the potential of Mira-55 to become a next-generation, non-opioid therapy," said Erez Aminov, CEO of MIRA. "With Mira-55 demonstrating meaningful anti-inflammatory and pain-modulating effects through oral administration, we believe MIRA is well positioned to advance multiple programs addressing some of the largest unmet needs in pain and neuroscience."

Dr. Itzchak Angel, CSA at MIRA, added: "Oral Mira-55's ability to normalize pain and directly suppress inflammation through CB2 activation highlights a major advance in cannabinoid-based therapeutics. These findings strengthen the rationale for moving this compound toward clinical development."

Market Opportunity and Strategic Positioning

Chronic inflammatory pain remains one of the largest and most underserved therapeutic markets, historically dominated by NSAIDs and opioids that carry well-documented safety and dependency risks. Mira-55's CB2-selective mechanism directly targets both pain and inflammation, offering a novel, non-opioid, non-NSAID alternative. The global non-opioid pain treatment market was valued at USD 45.3 billion in 2024 and is projected to reach USD 70.3 billion by 2030, growing at a CAGR of 7.7%. (Grand View Research, 2024)

Broader Preclinical Promise

Beyond its anti-inflammatory and analgesic profile, prior preclinical studies have shown that Mira-55 enhanced memory performance and reduced anxiety-related behavior, suggesting broader neurologic and neuropsychiatric potential.

About Mira-55

Mira-55 is a next-generation analog of marijuana engineered to selectively activate CB2 cannabinoid receptors associated with anti-inflammatory and analgesic effects 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, supporting its favorable regulatory profile and long-term commercial potential.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company developing novel therapies for neurologic, neuropsychiatric, and metabolic disorders. Its pipeline includes Mira-55, a non-psychoactive cannabinoid analog for chronic inflammatory pain with additional preclinical evidence of anti-anxiety and memory-enhancing activity; Ketamir-2, an NMDA-receptor antagonist in development for neuropathic pain; and SKNY-1, an oral drug candidate 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:
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

FAQ

What did MIRA (MIRA) announce about Mira-55 on October 16, 2025?

MIRA reported preclinical data showing oral Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine.

How was pain and inflammation measured in the Mira-55 preclinical study?

Pain was measured with Von Frey Filament testing and inflammation by paw-edema volume in a formalin-induced model.

Does the Mira-55 announcement mean MIRA filed an IND for chronic inflammatory pain?

The company said the data support planned IND activity; the release does not state an IND has been filed or approved.

How did Mira-55 compare to morphine in the announced preclinical results?

Oral Mira-55 fully normalized pain and produced direct anti-inflammatory effects, while injected morphine provided partial, indirect inflammation reduction.

What mechanism does Mira-55 use to reduce inflammation according to MIRA?

Mira-55's anti-inflammatory effect was described as CB2 receptor–mediated.

What is the market context mentioned for Mira-55 and MIRA (MIRA)?

The release cites a projected non-opioid pain market reaching USD 70.3 billion by 2030.