POTOMAC, Md., November 25, 2024 — IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") announced today the expansion of its clinical research program for IGC-AD1, an investigational treatment for Alzheimer's disease. Following Phase 2 interim results demonstrating reductions in agitation and improvements in cognitive function, the Company is launching new trials to evaluate IGC-ADI's potential as a disease-modifying therapy targeting amyloid plaques and tau tangles.
The expanded research will investigate how IGC-ADI’s dual-action mechanism-combining anti-neuroinflammatory properties with amyloid- and tau-targeting effects-can slow Alzheimer’s progression. These trials will assess critical outcomes, including cognitive function using the Mini-Mental State Examination (MMSE) and biological markers of Alzheimer’s pathology, such as amyloid and tau levels, at multiple time points. These investigations will build on previously announced preclinical data highlighting IGC-ADI’s promising effects on tau tangles and spatial memory.
“We are targeting patients as part of our new Phase 2 IGC-AD1 clinical trial in 2025,” said Ram Mukunda, CEO of IGC Pharma. “This new trial will position IGC Pharma at the forefront of Alzheimer’s research invocation. By exploring IGC-AD1’s mechanisms in broader applications, we are laying the groundwork for therapies that could address other neurodegenerative conditions, such as Parkinson’s and Frontotemporal Dementia. This holistic approach reinforces our commitment to addressing complex diseases by leveraging the power of alternative medicine combined with cutting-edge scientific practice.”
“The expanded trials also enhance IGC Pharma’s ability to forge strategic partnerships and licensing opportunities with other pharmaceutical companies, driving both scientific and financial value. By expanding IGC-AD1 to a disease modification market, we aim to deliver transformative treatments to patients who need them most while generating meaningful returns for shareholders.”
MMSE: A Key Cognitive Measure in Alzheimer's Research
The MMSE is a globally recognized and validated clinical tool used to measure cognitive function, including memory, attention, language, and orientation.
Widely employed in Alzheimer’s studies, it provides a standardized way to track cognitive changes and assess treatment efficacy. Biomarker analysis, meanwhile, will offer insights into IC-ADI’s potential impact on the underlying disease, complementing its demonstrated effects on behavior and cognition.
Building on Promising Preclinical Data
Preclinical studies in Alzheimer’s mouse models showed an approximate 50% improvement in spatial memory and cell line data showed a significant reduction in amyloid aggregation following treatment. These findings provide a strong scientific basis for the expanded research program, which aims to validate IGC-AD1’s ability to address both the symptoms and root causes of Alzheimer’s disease.
The ongoing 146-patient Phase 2 trial continues to enroll participants. With over 1,000 doses administered and no serious adverse events reported, the trial is on track to provide comprehensive safety and efficacy data by mid-2025.
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:
Rosalyn Christian
IMS Investor Relations
(203) 972-9200
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