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IGC Pharma Releases Positive Interim Analysis of its Ongoing Phase 2 Trial in Alzheimer’s Research

As of 2023, the estimated number of Americans living with Alzheimer’s disease was 6.7 million. However, a lesser-known subsection of Alzheimer’s is Agitation in dementia from Alzheimer’s Disease (AAD).

Recent research suggests that up to 76% of individuals with Alzheimer’s also suffer from Agitation in Alzheimer’s Dementia (AAD).

Agitation in Alzheimer’s Dementia (AAD) is known to contribute to accelerated cognitive decline, increased burden on caregivers, higher rates of hospitalization, and a greater need for medication, which collectively significantly diminish patients’ quality of life.

Unfortunately, existing therapies for Agitation in Alzheimer’s Dementia (AAD) carry black-box warnings, indicating the potential for serious adverse reactions that can result in death or serious injury.

Agitation in Alzheimer’s Dementia (AAD) has been associated with neuroinflammation, neurotransmitter imbalance, and CB1 receptor dysfunctions.

Research has also shown that Agitation in Alzheimer’s Dementia (AAD) correlates with an upregulation of the inflammasome-3 and can contribute to neuroinflammation, ultimately leading to aggressive behavior.

IGC Pharma (NYSE: IGC) aims to provide treatment options for millions of Americans battling Alzheimer's disease. Our investigational drug IGC-AD1 targets key mechanisms underlining Agitation in Alzheimer's Dementia (AAD) with a safe and effective therapy. Currently, there is no first-line medication for AAD, which effects 76% of Alzheimer's individuals, without a boxed warning.

Promising Clinical Studies For IGC-AD1

IGC-AD1 is undergoing extensive clinical trials to evaluate its effectiveness and safety in treating Alzheimer’s disease. The phase two clinical trial, begun in 2023, encompasses 20 sites across the United States and Canada. With a target of 146 participants, this trial focuses on determining the efficacy of IGC-AD1 in alleviating agitation, a common symptom experienced by many Alzheimer’s patients.

The Company has just announced the results of an interim analysis of its ongoing phase 2 trial. The main objective of the study is to evaluate the change in Agitation in Alzheimer’s Dementia (AAD) over six weeks, utilizing the Cohen Mansfield Agitation Inventory (CMAI).

The study showed that patients who were given IGC-AD1 had a more significant reduction in agitation levels compared to those who were given a placebo, with positive effects being observed as early as week two of the trial.

At the six-week mark, the difference in agitation levels between the IGC-AD1 group and the placebo group was quite noticeable, with an effect size of 0.66 according to Cohen’s d measure. The Least Square mean difference in the CMAI scores between the active treatment and placebo was -10.45, which indicates a meaningful contrast. Additionally, at the two-week mark, a secondary evaluation showed a Cohen’s d effect size of 0.79 for IGC-AD1 compared to placebo.

IGC-AD1’s interim results demonstrate a clinical and statistically significant reduction in agitation compared to placebo, suggesting a strong plausibility to address a substantial unmet medical need. This interim data validates IGC-AD1’s potential as a transformative therapeutic option with a large market opportunity in Alzheimer’s disease management,” said Ram Mukunda, CEO of IGC Pharma.

“We are actively pursuing next steps, including with regulators, and remain committed to advancing IGC-AD1 toward commercialization. We foresee a medication that can help alleviate caregiver burden and family distress as managing Alzheimer’s patients, especially ones with agitation, can have a significant emotional toll on families. With IGC-AD1’s promising clinical profile, we are confident in its ability, subject to further trials, to improve patient outcomes and drive shareholder value,” he added.

In 2023, Alzheimer’s and other types of dementia were projected to cost the U.S. $345 billion. By 2050, these costs could rise to nearly $1 trillion. IGC-AD1 offers a glimmer of hope for the millions of individuals living with Alzheimer's disease and their families.

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.


IMS Investor Relations
Walter Frank
(203) 972-9200

Janet Vasquez
(212) 645-5498

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