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Item 8.01 Other Events
MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
On June 30, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (the “Company”) announced new animal study results from SKNY-1, a next-generation oral therapeutic the Company is under definitive agreement to acquire from SKNY Pharmaceuticals, Inc.
In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior—all achieved within six days of oral treatment.
Key Results
Weight Loss and Muscle Preservation:
SKNY-1 reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than healthy controls. Importantly, this weight loss was not accompanied by muscle density changes—suggesting SKNY-1 helps burn fat while preserving lean body mass.
Metabolic Activity and Ventilation Rate:
Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy.
Liver and Lipid Profile Improvements:
In untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat back to healthy levels. At the same time, cholesterol levels—including LDL (‘bad’ cholesterol) and HDL (‘good’ cholesterol)—also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without disrupting the body’s overall metabolic balance.
Appetite, Craving, and Compulsive Eating:
Obese animals were eating 2–3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior—high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving.
Nicotine Craving and Compulsivity:
SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving.
Neurohormonal Balance:
Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the ‘hunger signal’). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body’s ability to regulate hunger and energy use.
Brain Dopamine Regulation:
Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels—but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain.
The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death—and a combined global market opportunity exceeding $200 billion—MIRA intends to prioritize SKNY-1 as a potential cornerstone asset pending completion of the acquisition of SKNY Pharmaceuticals, Inc.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACEUTICALS, INC. | ||
| Dated: June 30, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |