IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health

April 01, 2025 at 09:00 AM EDT

POTOMAC, MARYLAND / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.

Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer's disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer's and related conditions.

Ram Mukunda, CEO of IGC Pharma commented, "The addition of MIND Institute at Miami Jewish Health as a trial site strengthens our ability to reach a broader and more diverse patient population while accelerating the path toward regulatory approval. Their commitment to excellence in senior care and clinical research aligns with our mission, and we are excited to collaborate with their highly experienced team."

The trial at Miami Jewish Health will be led by Dr. Marc E. Agronin, a nationally recognized geriatric psychiatrist and Chief Medical Officer of MIND Institute. Dr. Agronin has dedicated his career to advancing neurocognitive research and improving the lives of older adults through innovative care models.

"Alzheimer's disease impacts millions of families, and effective treatments for agitation remain a critical unmet need," said Dr. Agronin. "At MIND Institute at Miami Jewish Health, we are proud to contribute to this important study, which has the potential to improve care and enhance quality of life for individuals living with Alzheimer's."

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.

With multiple trial sites now active across the U.S. and Canada, IGC Pharma remains focused on accelerating patient enrollment and generating data that could support regulatory approval and commercialization of IGC-AD1.

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 55 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Additionally, the Company operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity.

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

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IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health

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