IGC Pharma, Inc. (NYSE: IGC) today announced that its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's dementia has reached the Company's previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline.
The Company's prior enrollment updates described progress toward this 146-patient target. Based on observed and potential attrition between baseline, Week 2, and end-of-treatment assessments, IGC Pharma plans to continue limited over-enrollment to support the target evaluable population and strengthen the robustness of the dataset ahead of database activities and topline analysis.
"Reaching 146 baseline randomizations is an important operational milestone for CALMA and reflects the dedication of our investigators, study coordinators, patients, and caregivers," said Ram Mukunda, CEO of IGC Pharma.
"As the trial enters its final phase, our focus is on generating a high-quality, evaluable dataset that can support a meaningful topline analysis and the continued development of IGC-AD1 for agitation."
The CALMA trial is a randomized, double-blind, placebo-controlled Phase 2 study evaluating IGC-AD1 in patients experiencing agitation associated with Alzheimer's dementia. Agitation remains one of the most challenging neuropsychiatric symptoms affecting individuals living with Alzheimer's disease and their caregivers, creating a significant need for additional therapeutic options.
ICG ended Wednesday at 73 cents.
