- ClinCloud has dosed its first patient in trial investigating the safety and efficacy of IGC-AD1 on agitation in Alzheimer’s Disease -

IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced that ClinCloud, a clinical research facility in Florida, has dosed its first patient as part of the Company’s ongoing Phase 2b trial.

IGC Pharma is currently conducting a Phase 2b trial at twelve sites in the US and Canada with IGC-AD1, a combination medicine with a CB1 receptor partial agonist with anti-neuroinflammatory properties, and an inflammasome inhibitor to treat agitation in dementia from Alzheimer’s. Neuroinflammation, neurotransmitter imbalance, loss of CB1 receptors, and inflammasome-3 have been implicated in agitation/aggression.

ClinCloud has two sites in Florida, one in Maitland and the other in Viera-Melbourne. Individuals diagnosed with Alzheimer’s disease and/or their caregivers who live near the sites are encouraged to contact ClinCloud for information regarding enrolling in the trial. Contact information is available at clincloudresearch.com.

Jessica Branning, founder of ClinCloud, commented, “Treatment options targeting agitation in Alzheimer’s disease are currently limited. This symptom is present in over 50-80% of Alzheimer’s patients and is a source of significant distress for both patients and their caregivers. We’re glad to support this Phase 2b clinical trial as it aligns with ClinCloud’s goal of transforming healthcare with continuous improvements and revolutionary breakthroughs. As the global population ages, it is more important than ever to identify treatments for neuropsychiatric conditions. An oral solution with the ability to reduce agitation in Alzheimer’s would have a significant impact on patients’ quality of life.”

Ram Mukunda, CEO of IGC Pharma stated, “We are excited to announce this important addition to our Phase 2b trial of IGC-AD1. This strategic expansion amplifies our reach and strengthens the depth of our data collection, marking a critical phase in our pursuit of an innovative therapy for agitation in Alzheimer's disease. The expansion of our trial network underscores our commitment to a robust, scientifically driven approach, advancing our confidence in the potential of IGC-AD1. We continue to see progress in patient and trial site recruitment. I am optimistic that our partnership with ClinCloud will bring us closer to developing an effective and safe therapy to address the global challenge of Alzheimer’s disease.”

IGC Pharma has 12 sites and is on target to roll out additional sites in the U.S. and in Canada to increase population diversity and promote the inclusion of underrepresented populations. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo.

About IGC Pharma, Inc.

IGC Pharma is pursuing innovative solutions to fight Alzheimer’s disease and related challenges. IGC Pharma’s portfolio comprises of five assets, all with a singular mission – to transform the landscape of Alzheimer’s treatment. IGC-AD1 and LMP target neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is a CB1r partial agonist currently in a Phase 2b clinical trial for agitation in dementia due to Alzheimer’s (clinicaltrials.gov, NCT05543681). TGR-63 targets Aβ plaque to disrupt the progression of Alzheimer’s disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles in a forward-thinking approach to Alzheimer’s therapy. In parallel, IGC Pharma is at the forefront of Generative AI development, with projects including clinical trials, early detection of Alzheimer’s, and drug interactions with cannabinoids.

About ClinCloud

ClinCloud Clinical Research, (https://www.clincloudresearch.com/) has 2 centers located in Viera-Melbourne and Maitland, Florida, with active clinical studies in Alzheimer’s disease, and other diseases.

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 Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, 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.

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