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

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IGC Pharma, Inc. (NYSE American: IGC) announced the issuance of a patent for its treatment of Alzheimer’s disease, IGC-AD1, by the Divisional Direction of Patents, Mexico. The company is optimistic about potential approvals in the U.S. and Europe, and the success in Mexico is seen as a positive step towards commercialization. IGC-AD1 is a partial CB1 receptor agonist designed to address neurodegeneration in Alzheimer’s patients, with a Phase 2 trial currently underway. The company is also pursuing patent protection for IGC-AD1 in multiple jurisdictions. Alzheimer’s disease is a growing public health issue, and IGC-AD1 aims to improve the quality of life for affected individuals. IGC Pharma is also developing four other drug assets targeting agitation related to Alzheimer's disease.
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The recent announcement by IGC Pharma regarding the Mexican patent office's issuance of a Granting Office Action for their Alzheimer's treatment represents a noteworthy development within the pharmaceutical industry. This patent grant is a strategic advancement, securing intellectual property rights crucial for the company's growth and positioning in the market.

Alzheimer's disease is an area of high unmet medical need and treatments that can alleviate symptoms like agitation are in demand. The global prevalence and the projected increase in Alzheimer's cases underscore the potential market size and the significance of effective treatments. The mention of IGC-AD1's anti-neuroinflammatory properties suggests a novel approach to addressing the neuropsychiatric symptoms of Alzheimer's, which may differentiate it from existing therapies.

From an investment perspective, the progress of IGC Pharma's clinical trials, particularly the ongoing Phase 2 trial for IGC-AD1, is critical. Successful trials could lead to increased investor confidence and potential partnerships or licensing deals. However, the path to FDA approval in the U.S. and EMA in Europe is often challenging and uncertain. Investors should monitor the trial outcomes and regulatory interactions closely.

Overall, the patent grant in Mexico enhances the company's proprietary standing but should be viewed within the broader context of clinical efficacy, regulatory hurdles and market dynamics.

The advancement of IGC Pharma's IGC-AD1 through Phase 2 clinical trials is a pivotal step in the drug development process. The focus on agitation in Alzheimer's patients addresses a specific symptom that significantly impacts patient quality of life and caregiver burden. The therapeutic candidate's design as a partial CB1 receptor agonist indicates a targeted mechanism of action, which could offer benefits over general treatments.

It is important to consider that the success of clinical trials is not guaranteed and the data generated will be scrutinized for both efficacy and safety. The company's diversified portfolio, with five assets targeting Alzheimer's-related agitation, suggests a strategic approach to mitigate the risk inherent in drug development.

Long-term implications for stakeholders include the potential for a new standard of care in Alzheimer's treatment and the opportunity for IGC Pharma to capture a significant share of a growing market. However, the outcomes of the current and future clinical trials will be decisive in determining the drug's commercial viability.

The issuance of a patent in Mexico for IGC Pharma's Alzheimer's treatment is a positive sign for investors, as it may lead to market exclusivity in that region. This development can be seen as an indicator of the company's ability to protect its intellectual property, a key factor in the pharmaceutical industry's competitive landscape.

Financially, the implications of successful clinical trials and subsequent drug approval could be substantial. The treatment of central nervous system disorders, especially Alzheimer's disease, represents a large and growing market. The Alzheimer’s Association's projection of related costs soaring to $1 trillion by 2050 highlights the economic impact and the potential revenue stream for effective treatments.

Investors should weigh the costs of ongoing clinical trials against the potential for high returns in the event of successful commercialization. The company's stock price may fluctuate with trial results and regulatory news, reflecting the high-risk, high-reward nature of pharmaceutical investments.

POTOMAC, Md.--(BUSINESS WIRE)-- 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.

Investors

IMS Investor Relations

Walter Frank

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What is the latest announcement from IGC Pharma, Inc. (NYSE American: IGC)?

IGC Pharma announced the issuance of a patent for its treatment of Alzheimer’s disease, IGC-AD1, by the Divisional Direction of Patents, Mexico.

What is IGC-AD1?

IGC-AD1 is a partial CB1 receptor agonist designed to address neurodegeneration in Alzheimer’s patients, currently undergoing a Phase 2 trial.

What is the goal of the Phase 2 trial for IGC-AD1?

The Phase 2 trial aims to validate the effectiveness of IGC-AD1 in managing agitation in Alzheimer’s and relieving caregiver burden.

How many drug assets is IGC Pharma developing for the treatment of Alzheimer's disease?

IGC Pharma is developing five drug assets, including IGC-AD1, TGR-63, LMP, IGC-1C, and IGC-M3, targeting the treatment of agitation related to symptoms of Alzheimer's disease.

IGC Pharma, Inc.

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