Arizona Tribune - IGC Pharma Reaches 70% Enrollment in Phase 2 CALMA Trial Evaluating IGC-AD1 for Alzheimer's Agitation

The Company has approximately 23 active sites across 26 locations, and enrollment is progressing across this clinical network. IGC expects to complete enrollment by mid-2026. The Company believes this milestone meaningfully reduces the primary operational risk for the trial and positions CALMA to progress toward database lock and topline results.

"Reaching ~70% enrollment reflects improving execution and site productivity across our network," said Ram Mukunda, CEO of IGC Pharma. "Enrollment is the final operational gate, and our focus is straightforward: complete enrollment efficiently while maintaining data quality and rigorous trial conduct."

Operational Updates

The Company has continued to activate experienced sites and expand patient access through a hybrid, decentralized model in select geographies. IGC expects enrollment progress to continue as additional site capacity comes online, and newly activated sites ramp to steady-state contribution. In a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed on an ongoing interim basis to preserve blinding and trial integrity.

IGC-AD1 is an investigational, cannabinoid-based therapy being evaluated in a randomized, double-blind, placebo-controlled clinical trial designed to assess safety and efficacy in agitation associated with Alzheimer's disease.

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
[email protected]
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

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