MIRA Pharmaceuticals’ (NASDAQ:MIRA) Mira-55 Demonstrates Pain Normalization and Inflammation Reduction in Preclinical Study

Miami, Florida — October 16, 2025 — Leads & Copy — MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) 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.

The 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.

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

According to Erez Aminov, CEO of MIRA, these results highlight the strength of the company’s pipeline and the potential of Mira-55 to become a next-generation, non-opioid therapy. Dr. Itzchak Angel, CSA at MIRA, added that oral Mira-55’s ability to normalize pain and directly suppress inflammation through CB2 activation highlights a major advance in cannabinoid-based therapeutics.

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. 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.

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; 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.

Contact: Helga Moya, info@mirapharma.com, (786) 432-9792

Source: MIRA Pharmaceuticals, Inc.

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