Patent Granted to IGC Pharma for Groundbreaking Drug Formulation to Treat Agitation in Alzheimer’s

POTOMAC, Md.--(BUSINESS WIRE)--#AD--IGC Pharma, Inc. (“IGC Pharma” or the “Company”) (NYSE American: IGC), a clinical-stage pharmaceutical company, announced today that Divisional Direction of Patents, Mexico, has issued a Granting Office Action (GOA) for its treatment of Alzheimer’s disease titled “Method and Composition for Treating CNS Disorder.” The Company is optimistic that the success witnessed in Mexico can pave the way for additional approvals in the U.S. and Europe.

IGC Pharma is currently progressing a Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer’s disease, the most common form of a central nervous system disorder (CNS). IGC-AD1, the Company’s lead therapeutic candidate, is a partial CB1 receptor agonist designed with anti-neuroinflammatory properties to address the underlying neurodegeneration resulting in neuropsychiatric symptoms. IGC Pharma has strategically sought patent protection for the IGC-AD1 formulation in many jurisdictions including the U.S., Europe, Canada, and Mexico. Today’s announcement of the issuance of the patent for the drug formulation that targets Central Nervous System (CNS) Disorders marks an important milestone in helping set the stage for potential commercialization.

Alzheimer’s disease is a global public health issue affecting an increasing number of individuals as the population ages. According to the Alzheimer’s Association, by 2050, nearly 13 million Americans will be grappling with Alzheimer’s, and related costs are projected to soar to $1 trillion. The burden extends beyond the individual to families, caregivers, and society at large, with approximately 76% of Alzheimer’s patients experiencing neuropsychiatric symptoms such as agitation.

IGC-AD1 is designed to potentially revolutionize the treatment of Alzheimer’s by improving the quality of life of millions of individuals affected by this devastating disease. The current Phase 2 trial, alongside future investigations, aims to validate the effectiveness of IGC-AD1 in managing agitation in Alzheimer’s and relieving caregiver burden.

IGC Pharma is currently pursuing five drug assets targeting the treatment of agitation related to symptoms of Alzheimer's disease. These assets include IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, all of which are currently in different stages of clinical trials and development.

About IGC Pharma Inc. (dba IGC):

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.

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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