IGC Pharma Reaches Previously Disclosed 146-Patient Enrollment Target in Phase 2 CALMA Trial, Advancing Toward Topline Analysis
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7:30 AM on Thursday, June 11
The Associated Press
Company Continuing Limited Over-Enrollment Activities to Account for Attrition and Support Robust Modified Intent-to-Treat, End-of-Treatment and Exploratory Analyses
POTOMAC, MD / ACCESS Newswire / June 11, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") 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.
Following completion of limited over-enrollment activities and patient follow-up, IGC Pharma expects to proceed with database activities, site closeout activities, and subsequent topline analysis.
About IGC Pharma (dba IGC):
IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial ( CALMA ) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.
Contact Information:
Andres Sanchez
Investor Relations
+1 301-983-0998 / +1 (202) 569-2566
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
