POTOMAC, MD / ACCESS Newswire / March 20, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the expansion of its ongoing Phase 2 CALMA trial for IGC-AD1 with the addition of a new clinical site at Hamilton Health Sciences (HHS) in Ontario, Canada. This expansion marks a key milestone in IGC Pharma's strategy to advance IGC-AD1 toward commercialization, accelerating patient enrollment and expanding the Company's clinical footprint.
Hamilton Health Sciences is one of Canada's leading academic and research hospitals. The CALMA trial at HHS will be led by Dr. Alexandra Papaioannou, a distinguished geriatrician and Executive Director of HHS' Geras Centre for Aging Research, whose expertise in aging, frailty, and dementia will play a critical role in the trial's success.
"We are excited to welcome Hamilton Health Sciences as a site in the CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "Their world-class expertise in geriatric care and dementia research aligns with our mission to develop safe and effective therapies for Alzheimer's patients. Expanding the trial to this prestigious institution not only strengthens our study but also enhances patient access, accelerating our efforts to bring IGC-AD1 to market and deliver value for shareholders."
"Agitation is a significant challenge for Alzheimer's patients, their families, and caregivers," said Dr. Alexandra Papaioannou. "By participating in the CALMA trial, we aim to contribute to the development of urgently needed therapies to improve the quality of life for individuals living with this disease. We look forward to advancing research that has the potential to make a meaningful impact."
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.
About IGC Pharma (dba IGC): IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia ("CALMA") associated with Alzheimer's (clinicaltrials.gov, IGC Pharma Phase II). Interim data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 32 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions. The Company operates a wellness brand offering scientifically formulated products under the brand Holiby™ and as white-labeled formulations.
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.
