IGC Pharma Announces Additional Phase 2 Interim Results Highlighting Cognitive Benefits of IGC-AD1 for Alzheimer's Treatment

Rhea-AI Summary

IGC Pharma has announced additional interim results from its Phase 2 clinical trial of IGC-AD1 for Alzheimer's treatment. The active treatment group showed an average 8% improvement in cognitive function on the Mini-Mental State Examination over six weeks, while the placebo group showed no improvement. The trial primarily focuses on agitation reduction, where IGC-AD1 demonstrated significant improvements compared to placebo within two weeks. These results align with preclinical data showing 20% reduction in amyloid plaque aggregation and 50% improvement in spatial memory in mouse models. No serious adverse events were reported during the trial.

Positive

• 8% improvement in cognitive function demonstrated in treatment group vs placebo
• Significant reduction in agitation symptoms within 2 weeks of treatment
• Favorable safety profile with no serious adverse events reported
• Preclinical data shows 20% reduction in amyloid plaque and 50% improvement in spatial memory

Negative

• None.

Insights

Medical Research Analyst

The interim Phase 2 results for IGC-AD1 reveal meaningful dual benefits in both cognitive improvement and agitation reduction. The 8% improvement in MMSE scores over 6 weeks is particularly noteworthy, as cognitive benefits are rarely seen in agitation-focused treatments. The preclinical data showing 20% reduction in amyloid plaques and 50% improvement in spatial memory provides mechanistic support for these clinical findings.

The rapid onset of action for agitation (2 weeks vs 6-10 weeks for existing treatments) combined with a favorable safety profile differentiates IGC-AD1 in the competitive landscape. While these are interim results from a small trial, the dual mechanism addressing both symptoms and potential disease modification warrants attention, especially given the $50 billion projected market size by 2025.

Market Research Analyst

For a micro-cap company ($23.4M), these positive interim results could be transformative. The Alzheimer's market represents a massive opportunity, with 6.7 million American patients and effective treatment options. IGC-AD1's differentiated profile addressing both agitation and cognition could capture significant market share if approved.

However, investors should note that extensive additional trials will be required to confirm these findings and gain regulatory approval. The company will likely need substantial funding for Phase 3 trials and commercialization efforts. While the data is promising, the path to market remains long and capital-intensive, typical of biotech development programs.

- Interim results indicate cognitive improvement in the active treatment group compared to placebo

- No serious adverse events or deaths reported in the trial

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on agitation in Alzheimer's as its primary outcome, with cognition assessed as an exploratory outcome. Interim data analysis reveals cognitive improvements in the active treatment group versus the placebo group, marking a meaningful step toward developing a therapy that may influence underlying disease progression.

These findings align with previously announced preclinical data, which showed a reduction in amyloid plaque aggregation by approximately 20% and improved spatial memory by about 50% in Alzheimer's cell lines and mouse models, respectively.

Cognitive Improvements: A Key Marker of Disease Progression

Cognitive decline in Alzheimer's disease reflects the deterioration of memory, attention, language, and reasoning due to underlying pathological changes, such as amyloid plaques and tau tangles. Interim results from the trial demonstrated that the active treatment group receiving IGC-AD1 twice daily for six weeks showed an average improvement of about 8% on the Mini-Mental State Examination ("MMSE"), a validated clinical tool for assessing cognitive function. By contrast, the placebo group showed no improvement over the same period.

These results and the preclinical data provide a robust foundation for future trials focusing on cognition as the primary endpoint and exploring IGC-AD1's disease-modifying potential.

Ram Mukunda, CEO of IGC Pharma, commented, "The cognitive improvements observed in our interim results align with preclinical evidence of IGC-AD1's active pharmaceutical ingredients' impact on amyloid plaques and spatial memory. While agitation remains the primary focus of the Phase 2 trial, these exploratory findings strengthen our confidence in IGC-AD1's potential to address the broader pathology of Alzheimer's disease. For patients and caregivers, this potentially represents hope for improved care, and for our investors, it signifies a compelling opportunity in a growing market."

Primary Outcome: Agitation Reduction in Alzheimer's Patients

Agitation, a debilitating symptom affecting up to 76% of Alzheimer's patients, accelerates disease progression, increases caregiver burden, and drives hospitalization rates. As previously disclosed, interim results showed that IGC-AD1 significantly reduced agitation compared to placebo, with improvements observed as early as two weeks. Unlike the existing therapy, which often takes about 6–10 weeks to show results and carries a black box warning, IGC-AD1 offers rapid symptom relief with a favorable safety profile, making it a highly differentiated potential medication for managing agitation in Alzheimer's.

Alzheimer's disease affects 6.7 million Americans, with the global Alzheimer's treatment market projected to exceed $50 billion by 2025. IGC-AD1's unique profile—combining rapid onset for agitation with potentially disease-modifying effects—positions it as a highly differentiated therapy in this expanding field. "These developments aim to advance IGC-AD1 toward commercialization with more trials and regulatory approvals, potentially delivering transformative patient care while creating significant value for our investors," continued Ram Mukunda.

About IGC Pharma (dba IGC):

IGC Pharma is an AI-powered, clinical-stage biotechnology company focused on developing innovative treatments for Alzheimer's disease and transforming patient care with fast-acting, safe, and effective solutions. Our portfolio includes the TGR family, including TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. The IGC-C and IGC-M platforms are advancing in preclinical studies, focusing on metabolic disorders, tau proteins, early plaque formation, and multiple disease hallmarks. Our lead therapeutic candidate, IGC-AD1, is a cannabinoid-based treatment currently in a Phase 2 trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, NCT05543681). Clinical data for IGC-AD1 demonstrated that it has the potential to transform patient care by offering faster-acting and more effective relief compared to traditional medications. Additionally, our AI models are designed to predict potential biomarkers for the early detection of Alzheimer's, optimize clinical trials, and predict receptor affinity, among others. With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions.

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-Q filed with the SEC on August 7, 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. Contact:

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IMS Investor Relations

Rosalyn Christian / Walter Frank

igc@imsinvestorrelations.com

(203) 972-9200

Source: IGC Pharma, Inc.

FAQ

What are the Phase 2 interim results for IGC-AD1 in cognitive improvement?

The interim results showed an 8% average improvement in cognitive function on the Mini-Mental State Examination (MMSE) for patients receiving IGC-AD1 twice daily for six weeks, while the placebo group showed no improvement.

How quickly does IGC-AD1 show results in treating Alzheimer's agitation?

IGC-AD1 showed significant reduction in agitation compared to placebo within two weeks of treatment, faster than existing therapies which typically take 6-10 weeks.

What are the safety results of IGC-AD1 in the Phase 2 trial?

The Phase 2 trial reported no serious adverse events or deaths, demonstrating a favorable safety profile for IGC-AD1.

What were the preclinical results for IGC-AD1 in Alzheimer's treatment?

Preclinical data showed IGC-AD1 reduced amyloid plaque aggregation by approximately 20% and improved spatial memory by about 50% in Alzheimer's cell lines and mouse models.