IGC Pharma Completes Enrollment in Phase 2 CALMA Alzheimer's Trial

POTOMAC, Md., September 28, 2026 /CourierPR/ -- IGC Pharma, Inc., a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease and other indications, has completed enrollment in its Phase 2 CALMA trial evaluating its lead asset, IGC-AD1, for agitation in Alzheimer's dementia. The trial, which was designed to assess the safety and efficacy of IGC-AD1, has reached its target enrollment of 168 participants, with a diverse demographic that includes an average age of approximately 78 years, reflecting an older Alzheimer's dementia population. Approximately 53% of the participants were female, and the available race data indicated that 77% of participants were White, 16% were Black or African American, with the remaining participants identifying as other races or not being listed.

The CALMA trial, a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study, is being conducted across clinical sites in the United States and Canada, including academic and specialty centers such as Baycrest Academy for Research and Education, Butler Hospital - Memory and Aging Program, Hamilton Health Sciences, McGill University, and Miami Jewish Health. The primary endpoint of the trial is the change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory, a commonly used clinical assessment of agitation behaviors in dementia.

With the final participant dosing expected to conclude in early November, IGC Pharma is now focused on patient follow-up and database lock. The Company anticipates that the topline results will be available in the fourth quarter of 2026, as stated in the press release. The primary efficacy endpoint will be the change in agitation as measured by the Cohen-Mansfield Agitation Inventory. The trial's secondary and exploratory analyses will also be strengthened by the over-enrollment of participants, which was designed to provide a robust evaluable dataset.

Ram Mukunda, CEO of IGC Pharma, expressed gratitude to the participants, caregivers, investigators, and clinical teams involved in the CALMA trial.

The Data Safety Monitoring Committee has conducted periodic safety reviews and has recommended that the trial continue without modification. As of the Company's most recent safety reporting, no treatment-related serious adverse events have been identified. Safety data will remain subject to final review and analysis after database lock and unblinding. IGC Pharma remains committed to the rigorous scientific and regulatory evaluation of IGC-AD1, with plans for potential next-stage development based on the trial results.

The Company's lead asset, IGC-AD1, is being evaluated in the Phase 2 CALMA clinical trial for agitation in Alzheimer's dementia. The trial's primary efficacy endpoint is the change in agitation as measured by the Cohen-Mansfield Agitation Inventory. IGC Pharma is also developing AI-enabled tools intended to support biomedical discovery, data harmonization, and clinical development. The Company's focus remains on advancing its therapeutic candidates and providing innovative solutions for the treatment of Alzheimer's disease and other indications.