Mira Pharmaceuticals announces animal study results from SKNY-1

MIRA announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. 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. SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1’s potential as a differentiated oral therapy addressing two of the world’s leading causes of preventable death. The study was conducted in an obesity and craving model in Ob42 Strain-mc4r mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls. 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. 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. 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 and HDL-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. 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. 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. Obese animals had extremely high levels of leptin and unusually low levels of ghrelin. 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. 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.