POTOMAC, MARYLAND / ACCESS Newswire / March 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the addition of a new trial site at BayCare's St. Anthony's Hospital in St. Petersburg, Florida as part of its ongoing Phase 2 CALMA trial evaluating IGC-AD1, the Company's lead therapeutic candidate, for the treatment of agitation in Alzheimer's dementia.
IGC-AD1 is a combination therapy designed to address agitation in Alzheimer's disease. As a two-API formulation, it interacts with CB1 and CB2 receptors while targeting neuroinflammation, including pathways associated with the inflammasome, which has been implicated in both neurodegeneration and the inflammatory processes that contribute to agitation in Alzheimer's.
The CALMA trial aims to assess the safety and efficacy of IGC-AD1 in addressing this challenging symptom, which affects up to 76% of Alzheimer's patients and significantly impacts caregivers and healthcare systems. BayCare Health System, a leading not-for-profit healthcare provider, operates 16 hospitals and has a significant presence in West Central Florida, marking an important milestone in advancing the CALMA program. Leading the trial at St. Anthony's Hospital is Dr. Michael A. Franklin, a board-certified neurologist, accomplished researcher, and active member of the American Medical Association and the American Academy of Neurology.
"We are thrilled to welcome BayCare Health System, St. Anthony's Hospital, and Dr. Franklin to our CALMA clinical trial," said Ram Mukunda, CEO of IGC Pharma. "This addition strengthens our clinical research capabilities and underscores our commitment to improving diversity and inclusion in Alzheimer's trials. Florida's diverse population offers a unique opportunity to recruit underrepresented communities, ensuring that critical advancements in Alzheimer's treatments are accessible to all."
"Our physicians and providers are passionate about finding potential solutions for patients where gaps exist in therapies available today," said Danielle Mauck, BayCare's vice president of research and sponsored programs. "Partnerships on projects like CALMA allow us to support our physicians, providers, and patients with those efforts.
IGC-AD1 is currently being evaluated in a 146-patient Phase 2 trial targeting agitation in Alzheimer's dementia. Interim results have demonstrated significant reductions in agitation and exploratory cognitive improvements, with a strong safety profile and no serious adverse events reported. Additionally, preclinical studies showed that IGC-AD1 reduced amyloid plaques by approximately 20% and improved spatial memory by 50%, offering a promising foundation for expanded research. For more information on the CALMA trial and enrollment, please visit the official trial site or email calma@igcpharma.com.
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.
About St. Anthony's Hospital
St. Anthony's Hospital is a 448-bed hospital founded in 1931 as a ministry of the Franciscan Sisters of Allegany. The hospital has a rich history dedicated to improving the health of the community by providing high-quality, innovative and compassionate care, and recently opened a new patient tower with 90 private rooms. Part of BayCare Health System, St. Anthony's Hospital is located at 1200 Seventh Avenue North in St. Petersburg, Florida. For more information: BayCare.org/SAH.
About BayCare
BayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida's largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare's diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida's largest home care agencies, BayCare HomeCare. BayCare's mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.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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