Announcement • Sep 02

MIRA Pharmaceuticals Advances Non-Opioid Oral MIRA-55 For Inflammatory Pain Toward IND

MIRA Pharmaceuticals, Inc. announced positive results from completed 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs. MIRA-55 is the Company's investigational oral, non-opioid drug candidate being developed for inflammatory pain. The completed studies characterized tolerability, toxicity, and systemic exposure across both species. Rats were identified as the more sensitive species, while dogs demonstrated greater tolerance across the dose levels studied. Toxicokinetic analyses confirmed systemic exposure in both species and characterized how exposure changed with dose and repeated administration. The studies achieved their intended dose-range finding objective by generating the cross-species information needed to guide dose selection for the next phase of MIRA-55's ongoing IND-enabling program. The Company plans to use these findings to inform the design of subsequent GLP-compliant toxicology studies. The results of these studies further characterize the compound’s tolerability and systemic exposure across species and add to a broader preclinical profile that has demonstrated analgesic and anti-inflammatory activity, while prior behavioral studies showed that MIRA-55 did not produce the characteristic CNS effects associated with THC. The need for new approaches to pain management remains substantial. In 2023, 24.3% of U.S. adults experienced chronic pain, including 8.5% who experienced high-impact chronic pain that frequently limited life or work activities, according to the U.S. Centers for Disease Control and Prevention. The global non-opioid pain-treatment market was valued at approximately $45.3 billion in 2024 and is projected to reach approximately $70.3 billion by 2030, representing a projected compound annual growth rate of approximately 7.7%, according to Grand View Research. MIRA-55 is being developed within this landscape as an investigational oral, non-opioid therapy for inflammatory pain. In previously reported preclinical studies conducted separately from the toxicology studies announced, oral MIRA-55 normalized pain responses and significantly reduced inflammation in a validated inflammatory pain model, outperforming injected morphine in pain normalization. MIRA believes this combination of analgesic and anti-inflammatory activity represents a differentiated approach to inflammatory pain, where the goal is not only to address pain signaling but also the inflammatory processes contributing to pain. MIRA plans to use the completed dose-range finding data to support the next phase of its ongoing IND-enabling toxicology program. In parallel, the Company has successfully advanced manufacturing scale-up and formulation work for MIRA-55 in support of its broader preparations for clinical development. Subject to successful completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations, the Company is targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in the first quarter of 2027. MIRA-55 is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for inflammatory pain. The compound is designed to modulate cannabinoid receptor pathways associated with pain and inflammation while minimizing the characteristic psychoactive effects associated with THC. In previously reported preclinical studies, oral MIRA-55 demonstrated analgesic and anti-inflammatory activity, including normalization of pain responses and reductions in inflammation in a validated inflammatory pain model. Additional behavioral and mechanistic studies showed that MIRA-55 did not produce the characteristic CNS effects associated with THC and demonstrated a differentiated pharmacological profile. Following scientific review, the U.S. Drug Enforcement Administration determined that MIRA-55 is not classified as a controlled substance.

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