POTOMAC, MARYLAND / ACCESS Newswire / December 9, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.
This milestone marks a significant step in advancing IGC-AD1, the Company's proprietary formulation, and demonstrates continued strong momentum toward full enrollment consistent with the goal of completing the trial in early 2026.
Enrollment has accelerated, meaningfully, supported by the Company's data-driven digital recruitment strategy. Approximately 25% of all participants enrolled to date were recruited through IGC Pharma's targeted social-media campaigns, while 75% were enrolled directly through clinical-site efforts.
"Our hybrid recruitment strategy combining site-driven outreach with precision digital campaigns has expanded patient access and accelerated enrollment. We remain focused on completing the trial efficiently, maintaining high data quality, and advancing IGC-AD1 as a potential new therapy for agitation in Alzheimer's disease," said Ram Mukunda, CEO of IGC Pharma.
Agitation is a disruptive and highly prevalent symptom affecting over 76% of individuals living with Alzheimer's disease. Interim analyses of the Phase 2 trial, previously announced by the Company, have shown clinical and statistically significant reductions in agitation, underscoring the therapeutic potential of IGC-AD1. The Company continues to expand its clinical operations and strengthen site performance across the United States and Canada.
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 cannabinoid-based 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. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
Contact Information:
Rosalyn Christian / John Nesbett
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/igc-pharma-reports-65-patient-enrollment-milestone-in-phase-2-calma-alzheimers-agitat-1115768
