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

IGC Pharma, Inc.

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.

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