MIRA-55 shows pain relief matching Celebrex in chronic model study

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) reported that its oral compound MIRA-55 produced pain relief comparable in magnitude to celecoxib in a 21-day preclinical study of chronic inflammatory pain. The data indicate that once-daily dosing significantly reduced mechanical and thermal pain hypersensitivity, with p-values below 0.001 observed starting from the lowest dose tested.

The company stated that no statistically significant differences were found between MIRA-55 and celecoxib at higher doses. Effects were sustained over the three-week period without evidence of tolerance, and inflammation-associated swelling was reduced to a similar degree as with the comparator drug. Tolerability remained favorable, with no adverse clinical signs or deaths reported and normal body-weight gain maintained.

The study was conducted by an independent contract research organization using the Complete Freund’s Adjuvant model on 72 male and female rats. Results were consistent across both sexes. Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals, said the company is building a pain therapeutics franchise with MIRA-55 progressing toward an Investigational New Drug (IND) submission for inflammatory pain. The U.S. Drug Enforcement Administration has determined that MIRA-55 is not a controlled substance.

Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA Pharmaceuticals, noted that the durability of the response was encouraging. He added that the link between pain relief and reduced swelling suggests potentially distinct contributions from pain-signaling and inflammatory pathways, which the team is continuing to investigate.

These findings build on earlier preclinical work where MIRA-55 outperformed injected morphine in an acute inflammatory pain model. The compound is a next-generation oral synthetic cannabinoid analog designed to modulate cannabinoid receptor pathways while minimizing unwanted psychoactive effects. Safety and efficacy in humans have not been established.

Further tissue analyses are currently being performed to assess inflammatory cytokines and molecular markers linked to pain signaling and neuroinflammation in the dorsal root ganglia and spinal cord. These evaluations are expected to clarify the mechanism of action. MIRA Pharmaceuticals plans to submit the IND for MIRA-55 in the first quarter of 2027, subject to completion of remaining preclinical and regulatory activities.