Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 157

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 157
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 efficacy and pharmacokinetics/pharmacodynamics of single and repeated doses of CMND-100. To evaluate potential toxicity risks prior to human studies and to estimate starting doses for clinical trials, we have completed a series of pre-clinical, IND-enabling studies in the United States and China as required by the FDA for an investigational new drug designation before we can study our compound for the first time in humans. All studies were conducted by US based StageBio, a leading provider of GLP-compliant necropsy, histology, pathology, and specimen archiving services for the biopharmaceutical and research industry, and China based Wuxi AppTech, a certified, CRO that specializes in non-clinical drug development, and were organized by the following topics: safety pharmacology studies, pharmacokinetic studies, and toxicological studies. Pharmacokinetic (PK) and toxicokinetic (TK) of MEAI have been established in vitro and in the non-clinical species (mice, rats and/or dogs) used for assessing safety and efficacy. MEAI was found to have relatively rapid absorption and moderate to rapid elimination with no accumulation and no gender differences. The distribution of MEAI in tissues was evaluated in a binding study in vitro and in an in vivo study in mice. Collectively, this data provide a clear picture of the kinetic profile of MEAI in nonclinical species. Several in vitro studies were also conducted to investigate the metabolism of MEAI. Furthermore, drug interaction was studied in a series of in vitro assays. The toxicological effects of MEAI were studied by Clearmind in rats and dogs and included both single and repeat dose toxicity studies, genotoxicity, and special toxicity studies. Overall, a consistent toxicological profile was noted in the nonclinical species with the primary finding being adverse, transient, central nervous system (CNS)-related clinical signs. The type and severity of clinical signs increased in both rats and dogs in a dose-dependent manner. In the pivotal studies, no-observed-adverse-effect-level (NOAEL) doses were determined for both species. Genotoxicity studies conducted indicated that MEAI does not represent a mutagenic or clastogenic risk to humans. Based on these studies, we are planning to conduct a Phase I/II single and multiple dose tolerability, safety, and pharmacokinetic clinical study of CMND-100 in healthy volunteers and AUD subjects. 94 Competition The pharmaceutical industry is intensely competitive and subject to rapid and significant technological change. Our potential