POTOMAC, MD / ACCESS Newswire / September 22, 2025 / IGC Pharma, Inc. (NYSE American:IGC), a clinical-stage pharmaceutical company focused on therapies for Alzheimer's disease, today announced it has reached a key enrollment milestone of 50% 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 that combines low concentrations of delta-9 tetrahydrocannabinol (THC) a naturally derived cannabinoid, with another active pharmaceutical ingredient. Preclinical and clinical evidence suggest that IGC-AD1 has a multi-modal mechanism of action, reducing agitation while also demonstrating potential disease-modifying effects through activity against beta-amyloid plaques, tau tangles and diminished mitochondrial functioning.

"CALMA is a multicenter, double blind, placebo controlled, randomized trial. Enrolling 50% of the target is a key achievement for the CALMA program," said Ram Mukunda, CEO of IGC Pharma. "Agitation affects up to 76% of Alzheimer's patients and remains one of the most disruptive and underserved symptoms, with current treatments carrying black box warnings or serious side effects. IGC-AD1 offers the potential for a safer, better tolerated therapy that could meaningfully improve quality of life for both patients and caregivers. With encouraging data, from our Phase 1 and from the Phase 2 interim analysis, showing reductions in agitation, we are building strong momentum toward full enrollment and remain on track with our goal of completing the trial in early 2026."

In 2025, new sites were added to broaden geographic reach and enhance patient diversity, including BayCare Health System (Florida), Hamilton Health Sciences (Ontario), Butler Hospital's Memory and Aging Program (Rhode Island), Lynn Health Science Institute (Oklahoma), Island Health's Royal Jubilee Hospital (British Columbia), and SCB Research (Puerto Rico). With enrollment accelerating across this network of leading centers, IGC Pharma remains on track to complete recruitment in calendar 2026.

To learn more about IGC Pharma and the CALMA trial, please visit www.igcpharma.com.

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 30 patent filings 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 and it quarterly report on Form 10-Q filed with the SEC on June 27, 2025, and August 14, 2025, respectively 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.