IGC Pharma's Phase 2 Clinical Trial Interim Data Demonstrates Significant Reduction in Sleep Disturbances

Rhea-AI Summary

IGC Pharma (NYSE American:IGC) has reported positive interim results from its Phase 2 clinical trial of IGC-AD1, targeting agitation in Alzheimer's patients. The trial demonstrated significant reductions in sleep disturbances: 71% reduction at week 2 (p=.012) and 78% reduction at week 6 (p=.02) compared to placebo, measured via NPI-12 Sleep Subscale.

IGC-AD1, a cannabinoid-based partial CB1 receptor agonist, shows promise in addressing sleep disorders affecting up to 44% of Alzheimer's patients. The treatment's mechanism differs from traditional sedatives, potentially offering a safer alternative to current options like Trazodone and Suvorexant, which have shown effectiveness in dementia patients.

The ongoing CALMA trial's complete analysis is expected by end-2025. The company plans to evaluate IGC-AD1 as an Alzheimer's disease-modifying drug, targeting a global sleep aid market projected to exceed $100 billion by 2030.

Positive

• Significant sleep disturbance reduction: 71% at week 2 and 78% at week 6 with statistical significance
• Potential dual benefit: addresses both sleep disorders and agitation in Alzheimer's patients
• Large market opportunity: targeting $100B+ global sleep aid market by 2030
• Competitive advantage: shows better initial results compared to existing treatments (Trazodone and Suvorexant)

Negative

• Larger trials still needed to confirm efficacy and safety
• Complete trial results not available until end-2025
• Current results are interim and based on data

- IGC-AD1 Could Offer Safer Alternative to Existing Sleep Medications for Alzheimer's -

POTOMAC, MD / ACCESS Newswire / March 26, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced additional positive interim results from its ongoing Phase 2 clinical trial on IGC-AD1, an investigational treatment for agitation in dementia due to Alzheimer's disease.

Based on the interim analysis at week 2 sleep disturbance was reduced by about 71% (p=.012) and at week 6 about 78% (p=.02) for those on the active medication. These values indicate a clinical and statistically significant reduction in sleep disturbances among Alzheimer's patients receiving the active medication compared to placebo, as measured by the Neuropsychiatric Inventory ("NPI-12") Sleep Subscale.

The results suggest that IGC-AD1 may decrease the frequency and/or severity of sleep disturbances and nighttime behaviors, addressing a critical yet underrecognized challenge in Alzheimer's care that impacts up to 44% of Alzheimer's patients.

"IGC-AD1's ability to improve sleep quality in Alzheimer's patients is very exciting," said Ram Mukunda, CEO of IGC Pharma. "Better sleep is linked to reduced agitation and caregiver distress, as well as slowing cognitive decline and improving overall quality of life."

Improved sleep quality has been linked to reduced amyloid accumulation and slower disease progression. Additionally, previously reported data from the trial demonstrated notable reductions in agitation, reinforcing IGC-AD1's potential as a multi-targeted therapy for addressing neuropsychiatric symptoms in Alzheimer's patients.

Current treatment options including Trazodone and Suvorexant have shown limited improvement in placebo-controlled trials with dementia patients. IGC-AD1's differentiated mechanism offers the potential, if confirmed by larger trials, for a safer, more effective alternative for Alzheimer's patients.

Beyond Alzheimer's over 30 million Americans suffer from sleep disorders, which is a risk factor for cognitive decline and cardiovascular disease. The global sleep aid market is projected to surpass $100 billion by 2030, presenting, if verified through larger trials, a significant commercial opportunity for innovative therapies like IGC-AD1.

IGC-AD1 is a cannabinoid-based partial CB1 receptor agonist with anti-neuroinflammatory and neuroprotective properties. Unlike sedatives, which primarily mask symptoms, IGC-AD1 may, if confirmed by larger trials, provide a safer, more effective approach to target sleep regulation in Alzheimer's disease.

IGC Pharma is progressing its Phase 2 trial of IGC-AD1, recently named CALMA, with further analysis expected in the end-2025, including on sleep disturbance. The Company also expects to launch studies to evaluate IGC-AD1 as an Alzheimer's disease modifying drug.

For more information about the ongoing clinical trial, visit clinicaltrials.gov.

About IGC Pharma (dba IGC):

IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With 55 patent filings and a commitment to innovation, IGC Pharma is advancing breakthrough therapies. Additionally, the Company operates Holiby™, a wellness brand offering scientifically formulated products for immunity, energy, and longevity.

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 incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 24, 2024, and on Form 10-Qs filed with the SEC on August 7, 2024, November 12, 2024, and February 14, 2025, 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.

Contact Information:

Rosalyn Christian
IMS Investor Relations
igc@imsinvestorrelations.com
(203) 972-9200

SOURCE: IGC Pharma, Inc.

View the original press release on ACCESS Newswire

FAQ

What are the interim results of IGC's Phase 2 trial for IGC-AD1 in sleep improvement?

The trial showed 71% reduction in sleep disturbances at week 2 (p=.012) and 78% reduction at week 6 (p=.02) compared to placebo, measured by NPI-12 Sleep Subscale.

How does IGC-AD1 differ from traditional sleep medications for Alzheimer's patients?

IGC-AD1 is a cannabinoid-based partial CB1 receptor agonist with anti-neuroinflammatory properties, unlike traditional sedatives that mainly mask symptoms.

When will IGC Pharma complete the Phase 2 CALMA trial analysis?

The complete analysis of the Phase 2 CALMA trial is expected by the end of 2025.

What is the market potential for IGC-AD1 in the sleep aid industry?

The global sleep aid market is projected to exceed $100 billion by 2030, with over 30 million Americans suffering from sleep disorders.

What percentage of Alzheimer's patients could benefit from IGC-AD1's sleep improvement effects?

Up to 44% of Alzheimer's patients experience sleep disturbances that could potentially benefit from IGC-AD1.