SKNY-1

Aug. 06, 2026: MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) reported positive toxicokinetic data for SKNY-1, an oral obesity candidate, from a 7-day repeated-dose study in male and female Beagle dogs. SKNY-1 showed rapid oral absorption, dose-dependent systemic exposure, comparable plasma concentrations across sexes, and systemic accumulation with repeated dosing.

The company said the findings de-risk dose selection and will guide the planned GLP-compliant toxicology program, supporting SKNY-1’s regulatory path toward IND-enabling development. MIRA also said it is continuing additional preclinical efficacy and safety studies to build the nonclinical package for obesity.

Background details included in the release: peer-reviewed preclinical studies reportedly showed oral SKNY-1 produced dose-dependent weight reduction while preserving lean body mass, normalized lipids, reduced hepatic triglyceride accumulation, and attenuated compulsive feeding behavior. Separate behavioral studies reportedly found no anxiety-related effects despite engagement of central cannabinoid pathways. A lead oral formulation showed favorable bioavailability, brain penetration, and liver exposure, supporting potential once-daily dosing.

Pipeline update: Ketamir-2 for chemotherapy-induced peripheral neuropathy has completed Phase 1 and is advancing toward Phase 2a under an active IND; MIRA-55 is in development for chronic inflammatory pain.