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Item 8.01 Other Events
MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition
SKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in animal models—and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs
On July 10, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1)-related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS) effects.
The study was conducted using the light-dark preference test in zebrafish—a behavioral model used to assess anxiety-related responses. Zebrafish naturally prefer darker environments, but when anxiety levels are elevated, they avoid light even more strongly. Reduced dark preference (i.e., more time spent in the light) is interpreted as a calming effect.
Four groups were evaluated:
| ● | Control Group (No Drug): Fish displayed balanced light-dark behavior. | |
| ● | CP55,940 Group (CB1 Agonist): At high doses, CP55,940 increased time spent in the dark, indicating anxiety-related behavior. At low doses, it produced a calming effect. | |
| ● | Rimonabant Group (CB1 Inverse Agonist): Increased anxiety-like behavior was observed at both high and low doses of CP55,940. The response was greater than that of the CP55,940 group alone, consistent with previously documented psychiatric effects. | |
| ● | SKNY-1 Groups: In animals co-treated with CP55,940, SKNY-1 reversed the anxiety-inducing effects of high-dose CP55,940 and enhanced the calming effects at low doses. In all treatment conditions, SKNY-1 normalized behavior to control or better-than-control levels. |
SKNY-1 is under investigation for its differentiated pharmacological profile, which includes biased CB1 antagonism (blocking β-arrestin signaling while preserving G-protein signaling), partial CB2 receptor activation, mild MAO-B inhibition, and no inhibition of MAO-A as confirmed through in vitro screening. This profile is intended to avoid the psychiatric side effects historically observed with first-generation CB1 antagonists such as rimonabant.
MIRA Pharmaceuticals, Inc. is currently preparing for shareholder approval in connection with the proposed acquisition of SKNY Pharmaceuticals, Inc. Pending approval, the Company expects to initiate Investigational New Drug (IND)-enabling studies for SKNY-1.
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: July 10, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |