MIRA Pharmaceuticals completes toxicology studies for two drug candidates
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced it has completed the in-life dosing and scheduled necropsy phases of exploratory, non-GLP, 7-day repeated-dose toxicology and toxicokinetic studies for its two preclinical drug candidates, MIRA-55 and SKNY-1.
The studies evaluated both candidates in Sprague Dawley rats and Beagle dogs. According to the company, the studies are designed to provide data on tolerability, systemic exposure, and dose selection to inform the design of future GLP-compliant IND-enabling toxicology studies. Sample analysis, toxicokinetic evaluation, and histopathology remain ongoing.
MIRA-55 is an investigational oral small-molecule candidate targeting chronic inflammatory pain through CB2 receptor pathways. SKNY-1 is an investigational oral small-molecule candidate being developed for obesity and addiction-related disorders.
In addition to the toxicology studies, the company said it has been conducting formulation optimization, chemistry, manufacturing and controls activities, and manufacturing development for both programs in parallel.
"MIRA-55 and SKNY-1 continue to make meaningful progress across the key development activities required before entering IND-enabling studies," said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals.
Both candidates have been determined by the U.S. Drug Enforcement Administration not to be classified as controlled substances. The company's pipeline also includes Ketamir-2, which has completed a Phase 1 clinical trial and is advancing toward a Phase 2a study.
