IGC Pharma's Puerto Rico CALMA Trial Site Offers Strategic Opportunity in High-Prevalence Alzheimer's Market

Rhea-AI Summary

IGC Pharma (NYSE:IGC) has announced a new clinical trial site at Santa Cruz Behavioral (SCB) in Puerto Rico for its CALMA Phase 2 clinical trial, which is investigating IGC-AD1 for agitation in Alzheimer's disease. The strategic location addresses a significant market need, as Puerto Rico has a 12.5% Alzheimer's prevalence rate among those over 65, higher than the 10% rate in non-Hispanic white populations in the U.S.

The selection of Puerto Rico is particularly significant due to its rapidly aging demographic and unique genetic predispositions. Dementia-related medical care in Puerto Rico accounts for over 25% of total societal healthcare costs, exceeding proportions in the continental U.S. This new site complements IGC's existing trial location at the University of Puerto Rico.

Positive

• Strategic expansion into a high-prevalence market with 12.5% Alzheimer's rate in elderly population
• Partnership with established healthcare provider Santa Cruz Behavioral enhances trial diversity
• Access to underserved population could improve commercial viability and regulatory success

Negative

• None.

POTOMAC, MD / ACCESS Newswire / May 22, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced a clinical trial site at Santa Cruz Behavioral in Puerto Rico for its CALMA Phase 2 clinical trial, investigating IGC-AD1 for agitation in Alzheimer's disease. This strategic site directly addresses the significant impact of Alzheimer's in the region.

Approximately 12.5% of Puerto Ricans over the age of 65 have Alzheimer's, a figure notably higher than the roughly 10% prevalence observed in older non-Hispanic white populations in the U.S. This disparity is influenced by factors such as Puerto Rico's rapidly aging demographic and unique genetic predispositions. The heightened prevalence translates into a substantial economic burden, with medical care for dementia in Puerto Rico accounting for over a quarter of total societal healthcare costs, a proportion higher than in the continental U.S.

"We're pleased to work with Santa Cruz Behavioral ("SCB") as a trial site for our CALMA study, expanding our reach in Puerto Rico alongside a previously announced site at the University of Puerto Rico," said Ram Mukunda, CEO of IGC Pharma. "Puerto Rico represents a high-need and underserved population in Alzheimer's care, and SCB strengthens our ability to evaluate IGC-AD1 across diverse patient populations. Diversity in clinical trials not only improves scientific validity but also supports broader regulatory and commercial success."

For IGC Pharma's investors, this initiative represents a strategic imperative. By engaging a vast, underserved market with a high disease prevalence, diverse clinical trials are not only ethically sound but also enhance the commercial viability of therapies by ensuring universal effectiveness.

Santa Cruz Behavioral in Puerto Rico, known for its outstanding mental healthcare services from a biopsychosocial perspective, serves as a key partner in this endeavor.

Patients and caregivers interested in participating in the CALMA trial should please contact Santa Cruz Behavioral in Bayamon Puerto Rico.

About IGC-AD1 and the CALMA Trial

IGC-AD1 is IGC Pharma's investigational cannabinoid-based therapy currently in a Phase 2 multicenter, double-blind, randomized, placebo-controlled study (CALMA) evaluating its safety and efficacy for treating agitation in Alzheimer's dementia. Agitation affects up to 76% of Alzheimer's patients, often leading to increased hospitalization and caregiver burden. IGC-AD1 acts as a partial CB1 receptor agonist with anti-neuroinflammatory properties, targeting key pathways involved in neuroinflammation, oxidative stress, and neurotransmitter imbalances.

For more information on the CALMA trial, visit: ClinicalTrials.gov.

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 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 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.

Contact Information

Rosalyn Christian
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 clinical trial?

The CALMA Phase 2 clinical trial is investigating IGC-AD1, a treatment for agitation in Alzheimer's disease patients.

Why did IGC Pharma choose Puerto Rico for its clinical trial site?

Puerto Rico was chosen due to its high Alzheimer's prevalence rate of 12.5% among those over 65, which is higher than the mainland U.S., and represents an underserved market with unique genetic predispositions.

How many clinical trial sites does IGC Pharma have in Puerto Rico?

IGC Pharma has two clinical trial sites in Puerto Rico: the newly announced Santa Cruz Behavioral site and an existing site at the University of Puerto Rico.

What percentage of Puerto Rico's healthcare costs are related to dementia care?

Dementia-related medical care in Puerto Rico accounts for over 25% of total societal healthcare costs, which is higher than in the continental United States.