IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of Miami Jewish Health
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POTOMAC, MD / 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.