Paving the way for a potential Alzheimer’s drug

IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American: IGC) provides details on its drug candidate TGR-63, which targets amyloid-beta plaque and can potentially improve Alzheimer's disease treatment in a significant manner.

A key pathological marker of Alzheimer’s disease is the formation of abnormal clusters of protein fragments called amyloid-beta (Aβ) that deposit as Aβ plaque between neurons in the brain and contribute to cognitive decline and memory loss. The two drugs approved by the FDA, Aducanumab and Lecanemab, aim to clear Aβ plaque from the brain as part of a therapeutic approach focused on modifying the course of the disease.

TGR-63 is a patent pending molecule designed to disrupt the structure of Aβ plaque aggregation by disrupting intermolecular interactions and destabilizing their assembly. Studies in Alzheimer’s cell line have confirmed TGR-63's potency in alleviating Aβ plaque burden. As a result, large clusters of plaque fail to form, potentially stifling the progression of Alzheimer's Disease. TGR-63’s potential as an Alzheimer’s therapeutic was further corroborated in a genetically modified mouse model mimicking Alzheimer’s amyloid pathology. In that trial, the group treated with TGR-63, compared to the vehicle-treated group, showed a 78% and 85% reduction in the cortical and hippocampal amyloid load, respectively, reaffirming its potential to thwart the progression of Alzheimer’s disease. Notably, based on our research, we believe that TGR-63 exhibits excellent biocompatibility and the capacity to penetrate the blood–brain barrier. IGC Pharma hopes to progress TGR-63 into human trials.

Ram Mukunda, CEO of IGC Pharma, highlights the significance of TGR-63, saying, "The FDA's recent approval of innovative drugs like Aducanumab and Lecanemab underscores the profound impact of targeting plaque formation in Alzheimer's. TGR-63 aligns with this visionary approach, rekindling hope, and tangible progress in our fight against this neurodegenerative disease. TGR-63 is a potential Alzheimer’s drug in the standard preclinical methodologies, first in Alzheimer’s cell lines, then in amyloid animal models, and finally with its ability to penetrate the blood-brain barrier.”

The Company is currently advancing IGC-AD1, a CB1 receptor partial agonist, through a Phase 2b trial aimed at alleviating agitation in dementia due to Alzheimer’s Disease. This trial spans twelve sites across the U.S. and Canada, with data milestones based on patient recruitment efficiency anticipated in the second half of 2024. Successful readout of data from the trial can potentially generate significant value for the Company and, with further confirmations, address a profound unmet need, alleviating caregiver distress, reducing medication dependency, and curbing hospital admissions.

About IGC Pharma Inc. (dba IGC):

IGC Pharma is pursuing innovative solutions to fight Alzheimer’s disease and related challenges. IGC Pharma’s portfolio comprises five assets, all with a singular mission - to transform the landscape of Alzheimer's treatment. IGC-AD1 and LMP target neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently in a Phase 2b clinical trial for agitation in dementia due to Alzheimer's (clinicaltrials.gov, NCT05543681). TGR-63 targets Aβ plaque to disrupt the progression of Alzheimer's disease. IGC-M3 targets the inhibition of Aβ plaque aggregation with the potential to create a profound impact on early-stage Alzheimer’s. IGC-1C targets tau and neurofibrillary tangles as a forward-thinking approach to Alzheimer's therapy. In parallel, IGC Pharma is at the forefront of Generative AI development, with projects including clinical trials, early detection of Alzheimer’s, and drug interaction with cannabinoids.

Forward-Looking Statements:

This press release contains forward-looking statements. These forward-looking statements are mainly based 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, 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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