Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 76

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 76
---
 but lacking MAO-A action. The full profile is currently undergoing further evaluation. This property confers to SKNY-1 a very unique profile, enabling it to act on feeding mechanism, inflammation, reward, and smoking cessation. While this profile is reminiscent of the profile of THCV, it is different in the more potent extent of CB2 agonist properties of SKNY-1 and also its MAO-B activities, that are expected to play an important role in smoking cessation and accentuation of the anti-craving effects of the cannabinoid system.

SKNY-1 Development Plan and FDA Pathway Strategy

SKNY intends to pursue FDA approval of SKNY-1 for smoking cessation, with a secondary objective of demonstrating its ability to mitigate post-cessation weight gain—an unmet need not adequately addressed by currently approved therapies. The development program will include both preclinical and clinical stages, leading to an Investigational New Drug (IND) application submission.

| 38 |

Preclinical Development

The preclinical program will focus on:

| ● | Pharmacology                                                                                                                  
 and receptor-binding studies confirming modulation of CB1, CB2, and MAO-B pathways;                                           |
| ● | In                                                                                                                            
 vivo efficacy models for nicotine dependence and metabolic regulation;                                                        |
| ● | Toxicology                                                                                                                    
 and safety pharmacology studies, including GLP-compliant rodent and non-rodent studies; and ● ADME (absorption, distribution, 
 metabolism, and excretion) profiling.                                                                                         |

These studies will provide the foundation for a robust IND submission, enabling the initiation of human trials under U.S. FDA oversight.

Phase 1 – Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers

A randomized, double-blind, placebo-controlled trial will be conducted in healthy adult volunteers. The primary objective will be to assess the safety and tolerability of SKNY-1. Secondary objectives will include pharmacokinetics (PK) and pharmacodynamics (PD). Dosing will begin at subtherapeutic levels and be escalated under careful monitoring. Assessments will include vital signs, ECGs, clinical labs, and adverse event reporting.

Phase 2 – Proof-of-Concept Trial in Smokers with Focus on Weight Stability

Following a successful Phase 1, a Phase 2 randomized, placebo-controlled trial will be initiated in treatment-seeking adult smokers. The primary endpoint will be continuous smoking abstinence, typically measured over weeks 9–12 post-quit date in line with FDA guidance. Secondary endpoints will include:

|