Mira Pharmaceuticals, Inc. (NASDAQ: MIRA) announced preclinical results from formulation studies of MIRA-55, an oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain.

The company said it evaluated multiple oral formulations and selected a lead candidate that demonstrated oral bioavailability, sustained systemic exposure, and distribution into brain and liver tissue following oral administration, according to a press release.

The study included an intravenous reference arm to measure absolute oral bioavailability and support selection of the lead formulation based on its pharmacokinetic profile. The company said brain exposure may support modulation of central pain-processing pathways, while distribution to peripheral tissue may contribute to anti-inflammatory activity observed in earlier preclinical studies.

"Formulation optimization is far more than a pharmaceutical exercise — it is what enables a molecule to consistently engage its intended biological targets," said Itzchak Angel, Ph.D., Chief Scientific Advisor of Mira Pharmaceuticals. "The combination of favorable oral exposure together with reproducible brain and peripheral tissue distribution provides important support for MIRA-55's proposed mechanism of action."

The latest findings build on previously reported preclinical data in which oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model. Earlier studies also showed the compound demonstrated anxiolytic activity and did not produce central nervous system effects associated with THC.

MIRA-55 is described as a cannabinoid analog designed to modulate CB1 and CB2 receptor activity while minimizing CB1-related psychoactivity. The U.S. Drug Enforcement Administration has determined that MIRA-55 is not classified as a controlled substance.

Mira Pharmaceuticals said it plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as MIRA-55 advances through additional preclinical development.