IGC Pharma Releases Positive Interim Analysis Of Its Ongoing Phase 2 Trial In Alzheimer's Research
Detroit, Michigan
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April 03, 2024 09:00 AM Eastern Daylight Time
By Faith Ashmore, Benzinga
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 AAD. 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 AAD carry black-box warnings, indicating the potential for serious adverse reactions that can result in death or serious injury. AAD has been associated with neuroinflammation, neurotransmitter imbalance and CB1 receptor dysfunctions. Research has also shown that AAD correlates with an upregulation of the inflammasome-3 and can contribute to neuroinflammation, ultimately leading to aggressive behavior.
IGC Pharma (AMEX: IGC) is looking to provide treatment for millions of Americans struggling with ADD; its current drug, IGC-AD1, has been specifically designed to target the underlying causes of AAD and aims to fill the gap for a safe and effective therapy.
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 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 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 positive effect size of 0.79 for IGC-AD1 compared to the placebo.
"We are excited with the positive interim results from the Phase 2 trial of IGC-AD1 for agitation in dementia due to Alzheimer's disease. 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, as well as their families.
Featured photo by Ravi Patel on Unsplash
IGC Pharma Inc. (IGC) is at the forefront of the fight against Alzheimer's disease, developing innovative solutions to address this devastating illness. The company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2b clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is actively leveraging Artificial Intelligence (AI) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's.
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, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, 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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