IGC-AD1’s Interim Phase 2 Data Show a Reduction in Alzheimer’s Agitation at Week Two

Rhea-AI Summary

IGC-AD1's interim Phase 2 data shows a reduction in Alzheimer's agitation at week two, with a clinically significant reduction in agitation compared to placebo. The study achieves the secondary endpoint, demonstrating promising results in treating agitation in dementia due to Alzheimer's.

Positive

• IGC-AD1 demonstrates a clinically significant reduction in agitation in Alzheimer's at week two compared to placebo.
• The interim data show potential clinical benefit with infrequent treatment-limiting side effects.
• IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, containing THC as one of its active pharmaceutical agents.
• The Cohen Mansfield Agitation Inventory at baseline and week 2 exhibited an Effect Size of 0.79 (p=0.071), indicating a large magnitude of difference between the active and placebo groups.
• IGC-AD1 showed an effect size of 0.79 in two weeks, compared to Brexpiprazole's effect size of 0.35 in a significantly larger 12-week Phase 3 trial.
• Over 1,000 oral doses of IGC-AD1 have been administered in the ongoing 146-patient clinical trial, with no dose-limiting adverse events observed.

Negative

• None.

Insights

Medical Research Analyst

The interim Phase 2 data on IGC-AD1, which targets neuroinflammation and CB1 receptor dysfunction, is noteworthy for its indication of early clinical benefits in the management of agitation in Alzheimer's dementia. An Effect Size (ES) of 0.79 suggests a large magnitude of therapeutic effect, particularly when compared with the Effect Size of 0.35 from the FDA-approved Brexpiprazole. While ES is a standardized measure to gauge treatment effect, the reported p-value of 0.071 sits just above the conventional threshold for statistical significance. This means that while the results are promising, further studies are needed to validate these findings. Moreover, with an increasing prevalence of Alzheimer's, treatments that can alleviate symptoms like agitation are of high socio-economic importance, as they can potentially reduce caregiver burden, hospitalization rates and cognitive decline progression. For investors, the progression of IGC-AD1 through clinical trials, particularly if met with favorable results, could be a pivotal catalyst for IGC Pharma's stock valuation, considering the unmet needs in the Alzheimer's treatment landscape.

Healthcare Industry Analyst

The potential of a THC-based formulation such as IGC-AD1 to offer fast relief with minimal side effects addresses a significant unmet need in Alzheimer's care; approximately 6.5 million individuals in the U.S. are afflicted by this disease and a majority experience agitation. This symptom is challenging to manage and is linked to worse health outcomes. The innovative approach of targeting neuroinflammation and CB1 receptor dysfunction could distinguish IGC-AD1 within the pharmaceutical market, currently dominated by treatments with considerable side effects. The absence of dose-limiting adverse events further underscores its safety profile, an essential factor in treatment adherence and market adoption. If forthcoming data continues to reflect efficacy and safety, it could position IGC Pharma favorably within the market. Caution is warranted, however, as the investment community should be mindful of the risks inherent in clinical trial progression, regulatory approval processes and the potential for competitive drugs entering the market. The company’s engagement with regulatory authorities and progression to commercialization will be important for long-term investor confidence.

Financial Analyst

From a financial perspective, the clinical advancement of IGC-AD1 represents a key value inflection point for IGC Pharma. As the drug advances through the clinical trial phases, each milestone has the potential to significantly impact the company's stock. Especially important is the comparison of IGC-AD1's interim data to that of other approved treatments, which suggests a competitive edge. While the upfront costs of clinical trials are substantial, success could lead to marketable product with a strong revenue stream, given the large addressable market for Alzheimer's-related agitation. Nonetheless, investors should factor in the inherent volatility and risk associated with biotech investing, where positive clinical results do not always translate to market success due to factors such as market penetration, insurance reimbursements and even post-marketing surveillance outcomes. The long-term financial implications for IGC Pharma will largely hinge on successful Phase 3 trials, FDA approval and ultimately, market acceptance of IGC-AD1.

- Study Achieves Secondary End Point: Demonstrates Clinical Reduction, approaching statistical significance, at Week Two, in Agitation in Dementia due to Alzheimer’s -

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (“IGC Pharma,” “IGC,” or the “Company”) (NYSE American: IGC) today announced that interim data from its Phase 2 clinical trial demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.

IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents. THC is a principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease (clinicaltrials.gov, Identifier: CT05543681).

“We are excited to share that the interim results on the secondary outcome show that IGC-AD1 can provide fast relief with few side effects in reducing agitation in Alzheimer’s dementia compared to placebo. We are especially excited by these results given the limited therapeutic options currently available,” said Ram Mukunda, CEO of IGC Pharma.

“Alzheimer’s affects not only cognition but also mood and behavior that increase in intensity as the disease progresses. Approximately 6.5 million individuals in the U.S. live with Alzheimer’s and a majority experience a medical syndrome called agitation in Alzheimer’s dementia. There are various symptoms associated with this medical syndrome or condition such as screaming, pacing, biting, disrobing, excessive motor movements, physical aggression, and verbal aggression, among others. This medical condition makes it very difficult for caregivers to manage their loved one and is associated with increased hospitalization and accelerated cognitive decline.

“The interim data indicate early signs of potential clinical benefit with IGC-AD1 with infrequent treatment limiting side effects. We are encouraged by this data and will continue to work with the regulatory authorities on advancing IGC-AD1 through to commercialization,” added Mukunda.

The secondary outcome, as measured by the change in agitation versus placebo using a standard measurement scale, the Cohen Mansfield Agitation Inventory (“CMAI”) at baseline and week 2, exhibited an Effect Size (“ES”) of 0.79 (p=0.071) indicating a large magnitude of difference between the active and placebo groups. For context, a study published in 2003 concluded that an effect size over 0.5 corresponds to a change that is noticeable to a careful observer, highlighting the notable impact of IGC-AD1. Further, in May 2023, the FDA approved Brexpiprazole, an atypical antipsychotic, with a boxed warning. This approval followed a significantly larger 12-week Phase 3 trial, which showed a Cohen’s d effect size of 0.35 whereas IGC-AD1 showed an effect size of 0.79 in two weeks, emphasizing, subject to further trials, the potential of IGC-AD1 as a treatment option.

The ongoing 146-patient clinical trial is a multicenter, double-blind, randomized, placebo-controlled study designed to assess safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer’s. To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.

About IGC Pharma Inc. (IGC):

IGC Pharma Inc. (“IGC”) is focused on 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 2 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 seeks to leverage artificial intelligence (“AI”) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's.

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, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240416790137/en/

Investors

IMS Investor Relations

Rosalyn Christian / Walter Frank

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What does the interim data from IGC-AD1's Phase 2 clinical trial show?

The interim data show a clinically significant reduction in agitation in Alzheimer's at week two compared to placebo.

What are the active pharmaceutical agents in IGC-AD1?

IGC-AD1 contains THC as one of its active pharmaceutical agents.

What is the Effect Size of IGC-AD1 in the study?

The Cohen Mansfield Agitation Inventory exhibited an Effect Size of 0.79 (p=0.071), indicating a large magnitude of difference between the active and placebo groups.

How many oral doses of IGC-AD1 have been administered in the clinical trial?

Over 1,000 oral doses of IGC-AD1 have been administered in the ongoing 146-patient clinical trial.

What is the potential of IGC-AD1 as a treatment option compared to Brexpiprazole?

IGC-AD1 showed an effect size of 0.79 in two weeks, compared to Brexpiprazole's effect size of 0.35 in a significantly larger 12-week Phase 3 trial.