POTOMAC, MARYLAND / ACCESS Newswire / April 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the expansion of its ongoing Phase 2 CALMA clinical trial with the addition of Butler Hospital's Memory and Aging Program, a nationally recognized research center affiliated with the Warren Alpert Medical School of Brown University, in Providence, Rhode Island. The site will support enrollment for the CALMA study evaluating IGC-AD1, IGC Pharma's investigational therapy for agitation in Alzheimer's disease, a condition affecting a majority of Alzheimer's patients and significantly impacting caregivers.
Dr. Meghan Riddle, Associate Director of Butler Hospital's Memory and Aging Program and Associate Professor at The Warren Alpert Medical School of Brown University, will lead the trial at Butler. A geriatric psychiatrist, Dr. Riddle specializes in late-life mood disorders and neuropsychiatric symptoms related to dementia, bringing deep clinical and research expertise to the CALMA trial.
Butler Hospital's Memory and Aging Program ("MAP") is a nationally recognized leader in Alzheimer's research, dedicated to the prevention, diagnosis, and treatment of neurodegenerative diseases. The program provides comprehensive care for individuals and families affected by Alzheimer's, dementia, and memory loss, while advancing the field through cutting-edge clinical research and innovation in treatment strategies.
"We are excited to collaborate with Butler Hospital's Memory and Aging Program in advancing the CALMA clinical trial," said Ram Mukunda, CEO of IGC Pharma. "Their commitment to innovative patient care and cutting-edge research makes them a valuable partner in our mission to address the challenges of agitation in Alzheimer's patients. This expansion marks another important step in progressing our trial, bringing us closer to potential commercializing effective solutions for patients in need."
IGC Pharma's CALMA Phase 2 trial is being conducted in the United States, and Canada, with a goal of enrolling 146 participants. The study aims to evaluate IGC-AD1's potential in reducing agitation in Alzheimer's dementia, one of the most difficult-to-manage aspects of 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 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.
About the Memory and Aging Program at Butler Hospital:
The Memory & Aging Program (MAP) at Butler Hospital is a worldwide leader in Alzheimer's disease research and a local Rhode Island partner in the fight against Alzheimer's and other forms of dementia. An affiliate of The Warren Alpert Medical School of Brown University, MAP has a 25-year history of excellence in Alzheimer's clinical care, training, and research aimed at developing new and better ways to detect, treat, and someday even prevent Alzheimer's. Individuals who wish to be considered for participation in current and future research studies and clinical trials conducted at the Memory and Aging Program for the prevention and treatment of Alzheimer's disease can join the program's Alzheimer's Prevention Registry at Butler Hospital online at butler.org/ALZregistry or by calling (401) 455-6402. For more information visit butler.org/memory and follow on Facebook and Twitter.
About Butler Hospital:
Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research. For more information, visit butler.org.
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 / Walter Frank
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
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