IGC Pharma Completes Enrollment in Phase 2 CALMA Alzheimer's Trial; Topline Results Expected Q4 2026
https://www.accessnewswire.com/newsroom/en/bi...xp-1227682
POTOMAC, MD / ACCESS Newswire / September 28, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"
today announced it has completed enrollment in its CALMA Phase 2 trial evaluating lead asset, IGC-AD1, for agitation in Alzheimer's dementia.
Enrollment complete; final participant dosing expected to conclude in early November; topline results expected Q4 2026
CALMA achieved target enrollment with 168 participants randomized, including planned over-enrollment designed to strengthen the evaluable dataset for end-of-treatment, secondary, and exploratory analyses. Following the protocol-defined six-week treatment period, final participant dosing is expected to complete in early November, after which the Company expects to proceed toward database lock, unblinding, and topline analysis, with topline results expected in the fourth quarter of 2026.
"With target enrollment complete, CALMA has officially transitioned from recruitment to the final stage ahead of topline results," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "Our focus is now on patient follow-up and database lock as we prepare this 168-patient dataset for rigorous scientific and regulatory evaluation and potential next-stage development."
CALMA is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating IGC-AD1, an investigational oral solution dosed twice daily for six weeks, for agitation in Alzheimer's dementia. The primary endpoint is change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory. The trial was 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 enrolled population had an average age of approximately 78 years, reflecting an older Alzheimer's dementia population, and approximately 53% of participants were female. Based on available race data, approximately 77% of participants were White, 16% were Black or African American, and the remaining participants identified as other races or were not listed.
Agitation is one of the hardest symptoms of Alzheimer's dementia for families and caregivers to manage. It can contribute to emergency care, caregiver distress, earlier placement in residential care, and increased healthcare costs. IGC-AD1 is being developed as a potential treatment option for this high-burden patient population.
The Data Safety Monitoring Committee has conducted periodic safety reviews and at each review to date, has recommended that the trial continue without modification. The Company remains blinded to treatment assignment. As of the Company's most recent safety reporting, blinded safety monitoring had not identified any treatment-related serious adverse events as related to study treatment. Safety data remain subject to final review and analysis after database lock and unblinding.
"Completing enrollment is a defining clinical milestone for IGC Pharma," Mr. Mukunda continued. "We are grateful to the participants, caregivers, investigators, and clinical teams who made CALMA possible, and we look forward to reporting topline results."
https://www.accessnewswire.com/newsroom/en/bi...xp-1227682
POTOMAC, MD / ACCESS Newswire / September 28, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"
today announced it has completed enrollment in its CALMA Phase 2 trial evaluating lead asset, IGC-AD1, for agitation in Alzheimer's dementia. Enrollment complete; final participant dosing expected to conclude in early November; topline results expected Q4 2026
CALMA achieved target enrollment with 168 participants randomized, including planned over-enrollment designed to strengthen the evaluable dataset for end-of-treatment, secondary, and exploratory analyses. Following the protocol-defined six-week treatment period, final participant dosing is expected to complete in early November, after which the Company expects to proceed toward database lock, unblinding, and topline analysis, with topline results expected in the fourth quarter of 2026.
"With target enrollment complete, CALMA has officially transitioned from recruitment to the final stage ahead of topline results," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "Our focus is now on patient follow-up and database lock as we prepare this 168-patient dataset for rigorous scientific and regulatory evaluation and potential next-stage development."
CALMA is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating IGC-AD1, an investigational oral solution dosed twice daily for six weeks, for agitation in Alzheimer's dementia. The primary endpoint is change in agitation from baseline to week six on the Cohen-Mansfield Agitation Inventory. The trial was 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 enrolled population had an average age of approximately 78 years, reflecting an older Alzheimer's dementia population, and approximately 53% of participants were female. Based on available race data, approximately 77% of participants were White, 16% were Black or African American, and the remaining participants identified as other races or were not listed.
Agitation is one of the hardest symptoms of Alzheimer's dementia for families and caregivers to manage. It can contribute to emergency care, caregiver distress, earlier placement in residential care, and increased healthcare costs. IGC-AD1 is being developed as a potential treatment option for this high-burden patient population.
The Data Safety Monitoring Committee has conducted periodic safety reviews and at each review to date, has recommended that the trial continue without modification. The Company remains blinded to treatment assignment. As of the Company's most recent safety reporting, blinded safety monitoring had not identified any treatment-related serious adverse events as related to study treatment. Safety data remain subject to final review and analysis after database lock and unblinding.
"Completing enrollment is a defining clinical milestone for IGC Pharma," Mr. Mukunda continued. "We are grateful to the participants, caregivers, investigators, and clinical teams who made CALMA possible, and we look forward to reporting topline results."
