MIRA Pharmaceuticals has announced promising new preclinical data for SKNY-1, an oral drug candidate designed to address two major public health challenges—obesity and nicotine addiction—without the psychiatric side effects that have historically plagued cannabinoid-based therapies. The in vitro studies, conducted by Eurofins, support the therapeutic potential of this next-generation compound being developed by SKNY Pharmaceuticals, which MIRA has agreed to acquire pending regulatory approval and shareholder consent.
"We believe SKNY-1 could be a first-in-class oral therapy for two of the largest and most underserved markets: obesity and nicotine addiction," said Erez Aminov, CEO of MIRA. "What makes this drug candidate so exciting is its precision—it's engineered to avoid the psychiatric side effects that doomed earlier drugs in this class, while offering a safe, convenient, once-daily oral option."
Addressing Historical Safety Concerns
The development of SKNY-1 directly addresses the limitations of previous CB1-targeting drugs, most notably rimonabant (Acomplia®, Sanofi), which demonstrated weight loss and metabolic benefits but was withdrawn from the market due to serious psychiatric side effects, including depression and suicidal ideation. These adverse effects resulted from non-selective inhibition of CB1 signaling in the brain.
The Eurofins studies revealed that SKNY-1 operates through a fundamentally different mechanism as a biased CB1 modulator. The compound selectively blocks the β-arrestin signaling pathway, which is associated with cravings and compulsive behavior, while preserving G-protein signaling that is crucial for emotional and cognitive stability. This selective approach is designed to reduce cravings and body weight without disrupting mood.
Dual Receptor Strategy for Enhanced Efficacy
Beyond CB1 modulation, SKNY-1 demonstrates activity at the CB2 receptor, which plays a critical role in metabolic regulation and inflammation. The Eurofins data show that SKNY-1 behaves as a partial CB2 agonist, potentially enhancing fat metabolism, reducing peripheral inflammation, and improving insulin sensitivity. This dose-dependent flexibility distinguishes SKNY-1 from earlier CB1-only drugs and may enable broader therapeutic impact on obesity-related pathways.
"SKNY-1 combines modern pharmacology with real-world practicality," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "By precisely modulating CB1 and CB2 and supporting dopamine stability, it targets obesity and addiction through multiple, complementary mechanisms while potentially avoiding cannabinoid-related psychiatric side-effects."
Dopamine Regulation Without Stimulant Risk
The compound also demonstrates mild inhibition of the MAO-B enzyme, helping regulate dopamine—a neurotransmitter involved in motivation, focus, and reward. Importantly, SKNY-1 does not inhibit MAO-A, reducing the risk of serotonin-related side effects. The compound showed no or minimal antagonist binding to dopamine receptors (D1, D2, D3), further supporting its favorable CNS safety profile.
Market Position and Competitive Advantage
SKNY-1 is positioned as a differentiated alternative to injectable GLP-1 drugs, which have gained significant market attention but are often associated with gastrointestinal side effects and muscle loss. As an oral therapy, SKNY-1 may help preserve muscle mass and improve patient adherence by avoiding injections.
The market opportunity is substantial, with obesity and smoking remaining two of the world's leading causes of preventable death. The global obesity drug market is projected to surpass $150 billion in value by 2030, and the U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to over $50 billion by decade's end.
Development Timeline and Regulatory Path
MIRA is currently finalizing animal data related to weight loss and nicotine addiction, which will further support its development strategy and future regulatory filings. The company has submitted the required regulatory filings to the U.S. Securities and Exchange Commission in connection with the proposed acquisition of SKNY, with a shareholder vote to follow in accordance with SEC regulations.
Pending completion of the proposed acquisition, MIRA believes SKNY-1 could become a cornerstone asset within its pipeline, offering a next-generation solution to two major health challenges through its novel mechanism of action and improved safety profile.
