secwatch.observer — SEC 8-K summary
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Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2024-12-10T23:59:59+00:00
Accession:  0001493152-24-049377
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Mira Pharma completes Ketamir-2 GLP safety program; no adverse findings, IND submission by year-end 2024
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- Successful completion of GLP preclinical safety program for Ketamir-2; no adverse findings across cardiovascular, CNS, respiratory, and toxicology studies.
- Key results: cardiovascular safety in dogs, CNS assessment in rats (transient high-dose effects), 14-day dog tox up to 200 mg/kg, Ames test non-mutagenic.
- Plan to submit IND by end of 2024; Phase I trial start Q1 2025 for safety, tolerability, PK/PD, and pain evaluation.
- Early Phase I data expected Q2 2025; focus on neuropathic pain and psychosis.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315224049377/0001493152-24-049377-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315224049377/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-049377

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer