MIRA Pharmaceuticals Announces Initial Proof-Of-Concept Results From Pilot Study Of SKNY-1 For Obesity And Metabolic Disorders In A Diet-Induced Obesity Mouse Model; Study Demonstrated Statistically Significant Reductions In Body Weight And Fat Mass Following Oral Administration Of SKNY-1 Compared With Vehicle-Treated Controls

Key Findings From the SKNY-1 Pilot Study

Statistically Significant Weight and Fat Reduction

Oral SKNY-1 demonstrated statistically significant reductions in body weight and fat mass compared with vehicle-treated controls. The majority of the treatment-associated weight difference was attributable to fat reduction, providing encouraging evidence of SKNY-1’s activity in an established obesity model.

Favorable Lean-Mass Findings Compared With the Semaglutide Reference Group

At the Day 14 body-composition assessment, oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss relative to vehicle controls.

In contrast, semaglutide-treated mice demonstrated statistically significant lean-mass loss compared with vehicle-treated controls.

Limited Weight Regain Following Treatment Discontinuation Compared With Semaglutide

During the two-week observation period following treatment cessation, oral SKNY-1-treated mice demonstrated slow and limited weight regain.

In contrast, semaglutide-treated mice experienced rapid and substantial weight rebound, which was accompanied by a statistically significant increase in food consumption relative to vehicle controls, while oral SKNY-1-treated groups showed no statistically significant increase in food consumption.

Investigating a Potentially Differentiated Metabolic Mechanism

The study’s findings raise the possibility that SKNY-1 may influence energy expenditure, energy utilization, or other metabolic pathways involved in weight regulation, rather than relying primarily on appetite suppression.

These observations provide a scientific rationale for investigating SKNY-1’s potentially differentiated metabolic mechanism.

"One of the most intriguing findings from this pilot study is that SKNY-1 produced significant weight reduction without a statistically significant decrease in food consumption," said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals. "The contrasting observations in lean-mass outcomes and weight regain following treatment discontinuation compared with the semaglutide reference group are also scientifically interesting. Together, these findings raise the possibility that SKNY-1 may influence how the body utilizes energy, potentially offering a differentiated metabolic approach to weight management. These results further expand and confirm previous studies, which have demonstrated increased energy expenditure without changes in food intake."

"Our next study will investigate this hypothesis more directly through measurements of energy expenditure and other metabolic parameters, while further characterizing SKNY-1’s effects on body composition and weight regulation."

Continued Development of SKNY-1

MIRA is advancing SKNY-1 through longer-term preclinical studies to further assess weight reduction, body composition and metabolic effects, while continuing its IND-enabling development activities and chemistry, manufacturing and controls (CMC) manufacturing efforts to support future clinical development.