IGC Pharma Strengthens Regulatory Readiness as Phase 2 CALMA Alzheimer's Trial Approaches Enrollment Closure and Q4 Topline Readout
https://www.accessnewswire.com/newsroom/en/bi...ac-1206025
POTOMAC, MD / ACCESS Newswire / August 11, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"
, a clinical-stage biotechnology company developing treatments for Alzheimer's disease, today announced that it is strengthening its regulatory, biostatistical, artificial intelligence ("AI" -enabled data science, and strategic pharmaceutical development capabilities as IGC-AD1, the Company's lead Alzheimer's drug candidate, advances toward expected Phase 2 topline results in the fourth quarter of 2026.
CALMA has randomized 160 participants to date. IGC Pharma expects to close enrollment after up to additional participants, marking a key final enrollment milestone before patient follow-up, database lock, unblinding, and topline analysis. This final planned over-enrollment phase is intended to strengthen the dataset for end-of-treatment, secondary, and exploratory analyses.
The Company is strengthening these capabilities to support clinical data review, AI-assisted data quality activities, regulatory preparedness for potential engagement with the U.S. Food and Drug Administration ("FDA" and the European Medicines Agency ("EMA" , and strategic evaluation by potential pharmaceutical partners following completion of the Phase 2 CALMA trial. As part of this readiness effort, IGC Pharma has engaged OPIS Research, a full-service global contract research organization founded in Italy, to support EMA-related regulatory interactions.
"CALMA is moving through its final enrollment phase, and our focus is now on execution, data quality, and readiness for the next set of milestones," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "With 160 participants randomized and up to eight additional randomizations expected before enrollment closure, we are preparing the CALMA dataset for rigorous scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial. If supported by the CALMA results, we believe these activities could support a more efficient transition from clinical execution to data analysis, regulatory planning, and potential next-stage development."
IGC-AD1 is IGC Pharma's lead investigational therapeutic candidate for agitation associated with Alzheimer's dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.
As CALMA approaches enrollment closure and expected topline readout in the fourth quarter of 2026, IGC Pharma continues advancing both its Alzheimer's therapeutic pipeline and AI-enabled development capabilities in preparation for one of the Company's most significant clinical milestones to date.
https://www.accessnewswire.com/newsroom/en/bi...ac-1206025
POTOMAC, MD / ACCESS Newswire / August 11, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"
, a clinical-stage biotechnology company developing treatments for Alzheimer's disease, today announced that it is strengthening its regulatory, biostatistical, artificial intelligence ("AI" -enabled data science, and strategic pharmaceutical development capabilities as IGC-AD1, the Company's lead Alzheimer's drug candidate, advances toward expected Phase 2 topline results in the fourth quarter of 2026. CALMA has randomized 160 participants to date. IGC Pharma expects to close enrollment after up to additional participants, marking a key final enrollment milestone before patient follow-up, database lock, unblinding, and topline analysis. This final planned over-enrollment phase is intended to strengthen the dataset for end-of-treatment, secondary, and exploratory analyses.
The Company is strengthening these capabilities to support clinical data review, AI-assisted data quality activities, regulatory preparedness for potential engagement with the U.S. Food and Drug Administration ("FDA"
and the European Medicines Agency ("EMA" , and strategic evaluation by potential pharmaceutical partners following completion of the Phase 2 CALMA trial. As part of this readiness effort, IGC Pharma has engaged OPIS Research, a full-service global contract research organization founded in Italy, to support EMA-related regulatory interactions. "CALMA is moving through its final enrollment phase, and our focus is now on execution, data quality, and readiness for the next set of milestones," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "With 160 participants randomized and up to eight additional randomizations expected before enrollment closure, we are preparing the CALMA dataset for rigorous scientific, regulatory, and strategic evaluation following completion of the Phase 2 trial. If supported by the CALMA results, we believe these activities could support a more efficient transition from clinical execution to data analysis, regulatory planning, and potential next-stage development."
IGC-AD1 is IGC Pharma's lead investigational therapeutic candidate for agitation associated with Alzheimer's dementia, a condition that creates significant burden for patients, caregivers, clinicians, and healthcare systems. CALMA is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate IGC-AD1 in this population.
As CALMA approaches enrollment closure and expected topline readout in the fourth quarter of 2026, IGC Pharma continues advancing both its Alzheimer's therapeutic pipeline and AI-enabled development capabilities in preparation for one of the Company's most significant clinical milestones to date.
