MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced positive results from 7-day dose-range finding toxicology and toxicokinetic studies of its investigational drug candidate MIRA-55, an oral non-opioid compound being developed for inflammatory pain.

The studies, conducted in rats and dogs, 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 company said the findings will be used to guide dose selection for the next phase of its IND-enabling program, including the design of subsequent GLP-compliant toxicology studies. Manufacturing scale-up and formulation work for MIRA-55 are also said to be advancing.

Subject to successful completion of remaining IND-enabling studies and applicable regulatory requirements, MIRA is targeting submission of an Investigational New Drug application to the U.S. Food and Drug Administration in the first quarter of 2027.

In previously reported preclinical studies, MIRA-55 demonstrated analgesic and anti-inflammatory activity in a validated inflammatory pain model. Behavioral studies also showed the compound did not produce CNS effects associated with THC. The U.S. Drug Enforcement Administration has determined that MIRA-55 is not classified as a controlled substance.

"These tox results are an important milestone as we move toward human studies," said Erez Aminov, CEO of MIRA.

According to the company's press release, 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, citing Grand View Research.