IGC Pharma Breakthrough: Preclinical Trial Data Shows TGR-63 Reduces Plaque in Alzheimer’s

Rhea-AI Summary

IGC Pharma, Inc. provides details on its potential Alzheimer’s drug candidate TGR-63, which has shown promising results in disrupting the formation of amyloid-beta plaque in the brain. The drug has exhibited potency in alleviating plaque burden in Alzheimer’s cell lines and genetically modified mouse models. Additionally, TGR-63 has demonstrated excellent biocompatibility and the ability to penetrate the blood-brain barrier. The company is also advancing IGC-AD1, a CB1 receptor partial agonist, through a Phase 2b trial aimed at alleviating agitation in dementia due to Alzheimer’s Disease.

Insights

Medical Research Analyst

The announcement by IGC Pharma regarding their drug candidate TGR-63 is a significant development within the field of Alzheimer's disease therapeutics. The drug's mechanism, targeting amyloid-beta plaque, is aligned with the current FDA-approved drugs Aducanumab and Lecanemab. The ability of TGR-63 to disrupt the structure of Aβ plaque aggregation could be a game-changer in Alzheimer's treatment. The preclinical data showing a reduction in amyloid load in a mouse model is promising and suggests that TGR-63 could potentially slow the progression of the disease. The next steps for IGC Pharma will be to translate these preclinical findings into human trials, which is a critical phase for evaluating the drug's efficacy and safety in humans.

Financial Analyst

From a financial perspective, the development of TGR-63 represents a significant investment opportunity for IGC Pharma. Alzheimer's disease affects millions worldwide and any advancement in treatment options has the potential to capture a sizeable market share. The successful progression of TGR-63 into human trials and subsequent phases could lead to substantial revenue growth for the company. Investors will be closely monitoring patient recruitment efficiency and data milestones for the ongoing Phase 2b trial of IGC-AD1, as these factors will provide insights into the company's operational effectiveness and potential future profitability. The market tends to respond positively to advancements in drug development, especially in areas with unmet medical needs such as Alzheimer's disease.

Neurologist

As a neurologist, the potential of TGR-63 is of particular interest due to the high prevalence and impact of Alzheimer's disease on patients and the healthcare system. The ability of TGR-63 to penetrate the blood-brain barrier is crucial for its effectiveness in the central nervous system. The reported biocompatibility is also encouraging, as it suggests a favorable safety profile. However, the transition from preclinical studies to human trials is a significant hurdle and many compounds fail to demonstrate the same level of efficacy or safety in humans. The 78% and 85% reduction in amyloid load in cortical and hippocampal regions, respectively, in animal models, if replicated in human trials, could represent a substantial improvement in Alzheimer's disease management and patient outcomes.

Paving the way for a potential Alzheimer’s drug

POTOMAC, Md.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240123339435/en/

Investors

IMS Investor Relations

Walter Frank

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What is the potential Alzheimer’s drug candidate discussed in the press release?

The potential Alzheimer’s drug candidate discussed in the press release is TGR-63.

What is the ticker symbol for IGC Pharma, Inc.?

The ticker symbol for IGC Pharma, Inc. is IGC.

What is the drug IGC Pharma, Inc. is advancing through a Phase 2b trial for Alzheimer’s Disease?

IGC Pharma, Inc. is advancing IGC-AD1, a CB1 receptor partial agonist, through a Phase 2b trial aimed at alleviating agitation in dementia due to Alzheimer’s Disease.

What are the potential benefits of TGR-63 if successful?

If successful, TGR-63 can potentially alleviate caregiver distress, reduce medication dependency, and curb hospital admissions for Alzheimer’s patients.