Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 132

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 132
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 a state of enforced sobriety. The initial clinical trial will be a Phase 1/2 randomized double blind placebo controlled, in
healthy and AUD subjects evaluating the tolerability, safety and preliminary 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