Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 72

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 72
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ase B (MAO-B). CB1 is known to play a central role in modulating cravings for high-fat and high-sugar foods by influencing dopamine and appetite pathways. CB2, while not a direct driver of appetite, is associated with modulating stress and inflammation, which may indirectly contribute to craving-related behaviors. MAO-B regulates dopamine and trace amine levels, and its inhibition may help modulate the neurochemical environment associated with compulsive or reward-based eating.

Together, CB1, CB2, and MAO-B are part of interconnected systems—the endocannabinoid system and monoamine metabolism—that influence appetite, satiety, and behavior. These systems operate both centrally and peripherally, with potential implications for addressing conditions such as obesity and nicotine dependence.

The U.S. Drug Enforcement Administration’s (“DEA”) scientific review of SKNY-1 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act (“CSA”) and its governing regulations. This regulatory distinction significantly enhances SKNY-1’s commercial and clinical viability, removing potential barriers associated with controlled substances and positioning the compound for streamlined clinical development and commercialization.

SKNY was incorporated under the laws of the State of Delaware in December 2024.

Mechanism of Action of SKNY-1

The Endocannabinoid System, consisting of CB1 and CB2

The human body’s endocannabinoid system (ECS) is a complex network of receptors found throughout the body, including the brain, organs, connective tissues, glands, and immune cells. The primary function of the ECS is to maintain bodily homeostasis—biological harmony in response to environmental changes. The ECS comprises mainly two types of receptors: CB1 and CB2.

CB1 receptors, concentrated in brain regions such as the hypothalamus, nucleus accumbens, and prefrontal cortex, as well as in peripheral tissues like the gut and adipose tissue, play a key role in appetite regulation. The activation of the CB1 receptors by endocannabinoids (anandamide, 2-AG) or retrahydrocannabinol (“THC”) boosts dopamine in reward circuits and stimulates hunger—even when full—by enhancing signals from NPY/AgRP neurons. This “craving” effect heightens the appeal of food, especially for high-fat, high-sugar items. CB1 activation in the gut increases ghrelin signaling via the vagus nerve, while in fat tissue, it promotes storage and reinforces