IGC Pharma achieves 146-patient enrollment target in Phase 2 CALMA trial
IGC•IGC Pharma has randomized 146 patients at baseline in its Phase 2 CALMA trial of IGC-AD1 for agitation associated with Alzheimer’s dementia, meeting its previously disclosed enrollment target. The company plans over-enrollment to offset attrition and will proceed with database activities, site closeouts and topline analysis upon patient follow-up.
1. Enrollment Milestone
The company randomized 146 patients at baseline in its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer’s dementia, fulfilling its previously disclosed enrollment goal.
2. Over-Enrollment Strategy
To mitigate patient attrition between baseline, Week 2, and end-of-treatment visits, IGC Pharma is continuing limited over-enrollment to ensure a robust modified intent-to-treat population for primary and exploratory analyses.
3. Upcoming Data Analysis
Upon completion of follow-up and site closeout activities, the company plans database lock and commencement of topline analysis to assess safety and efficacy outcomes for IGC-AD1.
4. Pipeline and AI Focus
IGC Pharma leverages AI in its drug discovery process with programs targeting amyloid plaques, tau proteins and metabolic disorders, positioning IGC-AD1 as its lead asset in neuropsychiatric indications.
