secwatch.observer — SEC 8-K summary
======================================

Issuer:     IGC Pharma, Inc. (IGC)
CIK:        0001326205
Form:       8-K
Filed at:   2025-06-17T23:59:59+00:00
Accession:  0001185185-25-000657
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

IGC Pharma Phase 2 CALMA trial shows significant agitation reduction in Alzheimer's patients
--------------------------------------------------------------------------------

- Phase 2 interim: CMAI total score improvement -10.46 at week 6 (p=0.042, Cohen d=0.79) vs placebo.
- Sleep disturbance improved 71% at week 2 (p=0.012) and 78% at week 6 (p=0.02) on NPI-12 sleep subdomain.
- Phase 1 (n=13): no SAEs; agitation reduced significantly across all doses (p<0.05 each) on NPI agitation domain.
- Genotype-dependent PK: intermediate CYP2C9 metabolizers had longer IGC-AD1 half-life, potential for personalized dosing.
- Phase 2 CALMA trial targeting full enrollment of 146 participants for agitation in Alzheimer's dementia.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1326205/000118518525000657/0001185185-25-000657-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1326205/000118518525000657/igc8k061425.htm
  HTML page:      https://secwatch.observer/filing/0001185185-25-000657

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