IGC Pharma's TGR-63 Preclinical Results Show Substantial Reduction in Amyloid Plaque, a Key Hallmark of Alzheimer's Disease

Rhea-AI Summary

IGC Pharma announced promising preclinical results for its Alzheimer's therapeutic candidate, TGR-63. In mouse models, TGR-63 demonstrated a significant reduction in amyloid plaques—78% in the cortex and 85% in the hippocampus. This indicates potential for slowing or reversing Alzheimer's progression. TGR-63's effectiveness in disrupting amyloid beta aggregates and promoting neuronal viability was observed in cell cultures. The company plans to begin Phase 1 clinical trials for TGR-63 by 2025. IGC Pharma continues to develop its robust pipeline of Alzheimer's treatments, with a focus on leveraging AI for early disease detection and trial optimization.

Positive

• TGR-63 showed a 78% reduction in amyloid plaque in the cortex and 85% in the hippocampus in preclinical mouse models.
• TGR-63 has demonstrated potential neuroprotective effects in cell cultures.
• IGC Pharma has filed a U.S. patent application for TGR-63, potentially increasing its value.
• The company expects to start Phase 1 trials for TGR-63 in 2025.

Negative

• There is no assurance of similar results in human trials.
• Phase 1 trials for TGR-63 are not expected to begin until 2025, indicating a lengthy development timeline.

Medical Research Analyst

The preclinical results for TGR-63 in an Alzheimer’s mouse model reveal a significant reduction in amyloid plaques, which are key contributors to Alzheimer’s Disease (AD). Plaque reduction of 78 in the cortex and 85 in the hippocampus is noteworthy. The therapeutic potential of TGR-63 is promising, given these preliminary findings. Amyloid plaques are associated with cognitive decline, so a drug that effectively targets and reduces these plaques could be groundbreaking.

However, it is important to understand that these are preclinical results, which often do not guarantee similar outcomes in human trials. The transition from animal models to clinical trials involves numerous complexities, including dosing, safety and efficacy in humans. Furthermore, there have been many promising preclinical results in AD research that did not translate into effective treatments.

Overall, these findings are encouraging but should be interpreted with cautious optimism. The next steps involve rigorous clinical trials to evaluate TGR-63's efficacy and safety in human subjects. Investors should keep an eye on upcoming Phase 1 trials and subsequent studies to gauge the potential impact of TGR-63 in the Alzheimer’s treatment landscape.

Market Research Analyst

The announcement of TGR-63’s preclinical success is a positive indicator for IGC Pharma’s strategic positioning in the Alzheimer’s treatment market. Alzheimer's disease affects approximately 50 million individuals worldwide, representing a substantial market potential. Given that current treatments primarily manage symptoms rather than targeting the disease's root cause, a drug like TGR-63, if successful, could capture significant market share.

Moreover, the filing for patent protection enhances the company’s competitive edge, securing intellectual property rights which is critical for long-term commercial success. However, investors should be aware of the high-risk nature of biotech investments, particularly in drug development stages. The journey from preclinical success to market approval is fraught with hurdles, including potential setbacks in clinical trials and regulatory approvals.

Additionally, the company's current pipeline with multiple candidates focusing on different Alzheimer's mechanisms (e.g., tau protein, neurofibrillary tangles) shows a diversified approach, which may mitigate risk. Investors should monitor how IGC Pharma manages its resources and timelines to advance these candidates through the clinical stages.

- Mouse Studies Demonstrate Significant Reduction in Amyloid Plaque: 78% in Cortex and 85% in Hippocampus -

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (NYSE American: IGC) ("IGC" or the "Company") today announced encouraging preclinical results in an Alzheimer’s mouse model demonstrating the potential of the Company’s therapeutic candidate, TGR-63, to combat Alzheimer's disease.

“These preclinical results for TGR-63 are highly encouraging. The significant reduction in amyloid plaque burden in an Alzheimer’s mouse model observed in this study suggests TGR-63 has the potential to be a transformative treatment for Alzheimer's disease. TGR-63 is filed for patent protection in U.S. patent application (USPTO Patent Application Number: 18/006,578), further strengthening its potential value. We are committed to advancing TGR-63 through clinical trials to determine its efficacy and safety in human patients, offering new hope for the 50 million individuals affected by this devastating illness," said Ram Mukunda, CEO of IGC Pharma.

Alzheimer's disease is characterized by the buildup of abnormal protein aggregates in the brain, including amyloid plaques. These plaques are thought to play a major role in the cognitive decline and memory loss associated with the disease. Current medications for Alzheimer's primarily focus on reducing or clearing amyloid plaque, highlighting its importance as a therapeutic target.

In a mouse model of Alzheimer's, TGR-63 treatment led to a substantial reduction of amyloid plaque. Compared to untreated mice, TGR-63 treatment reduced plaque deposits by 78% in the cortex, a critical brain region for memory and cognition, and by 85% in the hippocampus, which plays a central role in learning and memory. These findings suggest TGR-63's potential to slow or even reverse the progression of Alzheimer's disease.

Prior to in vivo studies, TGR-63 demonstrated its ability to disrupt the formation of toxic amyloid beta (Aβ42) aggregates in cell cultures and increase the viability of neuronal cells exposed to Aβ42, indicating potential neuroprotective effects. TGR-63's unique structure allows it to interact with amyloid beta aggregates, potentially disrupting their structure and promoting their breakdown or clearance by the body's natural waste disposal systems. This could ultimately lead to a reduction in plaque burden in the brain, although there can be no assurance. The positive results from these preclinical studies could pave the way for advancing TGR-63 through clinical trials. IGC Pharma expects to begin a Phase 1 trial for TGR-63 in 2025, although there can be no assurance.

About IGC Pharma, Inc.

IGC Pharma (“IGC”) is focused on Alzheimer’s disease, developing innovative therapies 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 is currently undergoing a Phase 2 clinical trial for agitation in dementia associated with Alzheimer’s (clinicaltrials.gov, NCT05543681).

The remaining four molecules are in the pre-clinical stage of development. TGR-63 disrupts the progression of Alzheimer’s by targeting Aβ plaques, a key hallmark of Alzheimer’s. IGC-1C, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer’s therapy. IGC-M3, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer’s. LMP is designed to target multiple hallmarks of Alzheimer’s including plaques and tangles for a comprehensive approach to the disease. In addition to our drug development pipeline, we are harnessing the power of Artificial Intelligence to develop early disease detection models, optimize our clinical trials, and explore new applications for our drugs.

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 24, 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/20240625363805/en/

Investors

IMS Investor Relations

Walter Frank/Rosalyn Christian

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What are the preclinical results of IGC's TGR-63 in Alzheimer's research?

IGC's TGR-63 showed a 78% reduction in amyloid plaques in the cortex and 85% in the hippocampus in preclinical mouse models.

When will IGC Pharma begin clinical trials for TGR-63?

IGC Pharma plans to start Phase 1 clinical trials for TGR-63 in 2025.

What potential does TGR-63 have in treating Alzheimer's?

TGR-63 has shown potential to reduce amyloid plaques significantly and demonstrated neuroprotective effects in cell cultures, suggesting it could slow or reverse Alzheimer's progression.

What is the significance of amyloid plaque reduction in Alzheimer's disease?

Amyloid plaques are linked to cognitive decline and memory loss in Alzheimer's patients; reducing them is a key therapeutic target.

Has IGC filed for patent protection for TGR-63?

Yes, IGC has filed a U.S. patent application (No. 18/006,578) for TGR-63.