IGC Pharma Expands CALMA Phase 2 Trial to Island Health's Royal Jubilee Hospital in Canada

Rhea-AI Summary

IGC Pharma (NYSE American:IGC) announced the expansion of its Phase 2 CALMA clinical trial for IGC-AD1, a novel treatment for agitation in Alzheimer's dementia, to Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada.

The CALMA trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of IGC-AD1 in managing agitation in Alzheimer's patients. This expansion strengthens the trial's clinical infrastructure across North America and aims to increase access for patients and caregivers while supporting timely enrollment towards trial completion.

Positive

• Expansion to international site in Canada broadens patient population diversity
• Addition of experienced research center strengthens clinical trial infrastructure
• Progress in Phase 2 trial development and geographical expansion

Negative

• None.

POTOMAC, MD / ACCESS Newswire / September 2, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced expansion of its ongoing Phase 2 clinical trial evaluating IGC-AD1, a novel investigational treatment for agitation in Alzheimer's dementia, to a new international site at Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada.

"Bringing CALMA to Canada is a milestone in our mission to offer innovative solutions for individuals living with Alzheimer's disease," said Ram Mukunda, CEO of IGC Pharma. "This expansion reflects the CALMA trial's continued growth across North America, broadening access to diverse patient populations and reinforcing IGC's commitment to advancing IGC-AD1 through a robust, multi-site clinical program. We are honored to collaborate with the experienced team at Island Health to reach more families affected by this condition."

This marks the CALMA trial's continued growth across North America, aiming to increase access for patients and caregivers affected by Alzheimer's disease and its neuropsychiatric symptoms. The addition of Royal Jubilee Hospital strengthens the trial's clinical infrastructure and supports timely enrollment as the Company works toward trial completion.

The CALMA Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in managing agitation in patients with Alzheimer's disease, a symptom that significantly impacts quality of life and care outcomes.

Island Health's Clinical Trials Unit at Royal Jubilee Hospital is now actively involved in the CALMA study. For site inquiries or additional information, please contact:

Clinical Research Coordinator
Royal Jubilee Hospital
1952 Bay Street - Memorial Pavilion - Kenning Wing 1^st Floor
Victoria, BC V8R 1J8
Phone: 250.370.8340 or 250-519-7700 Ext: 13511

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

About Island Health
Island Health is one of British Columbia's five regional health authorities, providing comprehensive health care services to more than 850,000 residents across Vancouver Island, the Gulf Islands, and parts of the mainland. The Clinical Trials Unit at Royal Jubilee Hospital in Victoria is a leading center for medical research, dedicated to advancing clinical innovation and patient-centered care. Through partnerships with academic institutions and global sponsors, Island Health contributes to the development of evidence-based treatments that improve outcomes and enhance quality of life.

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 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

FAQ

What is the purpose of IGC Pharma's CALMA Phase 2 trial?

The CALMA trial is evaluating IGC-AD1, a novel treatment for managing agitation in Alzheimer's dementia patients, through a randomized, double-blind, placebo-controlled study.

Where is IGC Pharma expanding its CALMA Phase 2 trial?

IGC Pharma is expanding the trial to Island Health's Royal Jubilee Hospital in Victoria, British Columbia, Canada, marking its international expansion.

How can patients participate in IGC Pharma's CALMA trial at Royal Jubilee Hospital?

Interested participants can contact the Clinical Research Coordinator at Royal Jubilee Hospital in Victoria, BC, at 250.370.8340 or 250-519-7700 Ext: 13511.

What type of study design is IGC Pharma using for the CALMA Phase 2 trial?

The CALMA trial uses a randomized, double-blind, placebo-controlled study design to assess the safety and efficacy of IGC-AD1.

How does the CALMA trial expansion benefit IGC Pharma's research?

The expansion strengthens the trial's clinical infrastructure, increases patient access across North America, and supports timely enrollment through a more diverse patient population.