Promising Results: TGR-63 Enhances Memory in Alzheimer's Mouse Model

Rhea-AI Summary

IGC Pharma, Inc. announced positive results from preclinical studies on drug candidate TGR-63 for Alzheimer's disease. The data showed enhanced memory function in an Alzheimer's mouse model, targeting Aβ peptide misfolding and aggregation.

Insights

Medical Research Analyst

The announcement by IGC Pharma regarding preclinical studies of TGR-63 represents a significant milestone in the search for effective treatments for Alzheimer's disease. The preclinical data suggesting enhanced memory function in an Alzheimer's mouse model touches upon a critical unmet need in the current therapeutic landscape. The ability of TGR-63 to disrupt the structure of the amyloid-β peptide could potentially translate into a novel mechanism of action, distinguishing it from existing treatments that primarily focus on symptom management rather than disease modification.

From a medical research perspective, the use of behavioral tests such as the Novel Object Recognition Test and the Morris Water Maze is a robust approach to assessing cognitive function in animal models. These tests are widely recognized for their ability to evaluate various aspects of memory and learning, which are profoundly affected in Alzheimer's patients. Should these results be replicated in human trials, TGR-63 could represent a breakthrough in the management of Alzheimer's disease, providing hope for improved quality of life for patients and their families. However, it is crucial to remain cautious as many compounds that show promise in preclinical studies do not always translate to human efficacy.

Financial Analyst

The disclosure of positive preclinical study results for TGR-63 by IGC Pharma could potentially have an impact on the company's stock valuation. Alzheimer's disease represents a market with a high unmet medical need and successful drug candidates can lead to significant revenue streams. Investors often respond favorably to announcements of therapeutic advancements, especially in areas of high disease burden such as neurodegenerative disorders.

However, it is important to analyze these results within the context of the drug's development stage. Preclinical success does not guarantee regulatory approval or market success. The pathway from preclinical studies to commercialization is fraught with clinical, regulatory and financial challenges. Investors should consider the long development timelines, potential need for capital raises and the competitive landscape. Moreover, the actual market potential of TGR-63 will depend on various factors including clinical trial outcomes, pricing, insurance coverage and physician adoption post-approval.

Biotech Market Analyst

The Alzheimer's disease treatment market is highly competitive, with several major pharmaceutical companies investing heavily in the development of new therapies. The positive preclinical results of TGR-63 place IGC Pharma among the companies to watch in this space. The targeting of amyloid-β peptide misfolding and aggregation by TGR-63 could potentially offer a differentiated approach compared to other drugs in the pipeline, which may focus on tau pathology, inflammation, or other aspects of the disease.

Understanding the competitive landscape is essential for stakeholders. If TGR-63 progresses to clinical trials, it will be important to monitor how it compares in terms of efficacy, safety and ease of use with other drugs in development. Market penetration will depend not only on clinical success but also on strategic partnerships, marketing and the ability to navigate the complex regulatory environment. The long-term potential of TGR-63 will be shaped by these factors and its impact on the market will be better assessed as the drug advances through the development pipeline.

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American: IGC) today announced the results of preclinical studies investigating its drug candidate TGR-63 as a treatment for Alzheimer's disease. The data demonstrated enhanced memory function in an Alzheimer's mouse model, including improved memory acquisition, consolidation, and retrieval.

TGR-63 is a therapeutic candidate designed to disrupt the structure of the amyloid-β (Aβ) peptide, mitigating symptoms such as memory loss and disrupted learning ability, signs of cognitive impairment. TGR-63 targets a critical neuropathological hallmark of Alzheimer's Disease by addressing the misfolding and aggregation of Aβ peptides, specifically the toxic Aβ42 aggregation species associated with neuronal toxicity and cognitive decline. The cognitive impact of TGR-63 was assessed using two renowned behavioral tests, the Novel Object Recognition ("NOR") Test and the Morris Water Maze ("MWM"), conducted on APP/PS1 genetically modified Alzheimer's mice.

Ram Mukunda, CEO, commented, "These results underscore the efficacy of TGR-63 in enhancing spatial memory function in an Alzheimer's disease model, offering promising implications for potential therapeutic interventions in Alzheimer's and related neurodegenerative conditions. The improvements in memory acquisition, consolidation, spatial memory formation, and retrieval highlight its potential in addressing cognitive impairment in Alzheimer's Disease. We are optimistic about TGR-63's potential and anticipate advancing it towards a Phase 1 trial, enriching our clinical portfolio."

The NOR Test, a cornerstone of preclinical research, evaluates recognition memory, a component of declarative memory responsible for recognizing previously encountered stimuli. Widely applicable across neuropharmacology and neurobiology, this test provides crucial insights into memory function and potential interventions for memory-related disorders such as Alzheimer's. During the NOR Test, Alzheimer's mice displayed a significantly diminished Discrimination Index ("DI") compared to normal mice, indicating impaired long-term memory. TGR-63-treated Alzheimer's mice showed a 51% improvement in DI, signifying promising therapeutic efficacy. After 48 hours, while untreated Alzheimer's mice experienced a 100% decline in memory, those treated with TGR-63 demonstrated an 86% increase in DI, suggesting robust long-term potentiation ("LTP") formation and successful memory retrieval.

The Morris Water Maze ("MWM") is a pivotal tool in cognitive research, offering deep insights into spatial learning and memory processes. In this test, mice are trained to find a hidden platform in a pool over four days. Particularly crucial in neurodegenerative diseases like Alzheimer's, the MWM allows researchers to explore spatial navigation and memory formation mechanisms. Over four days of training, TGR-63-treated mice exhibited a statistically significant reduction in the time required to locate the hidden platform, reflecting improved spatial memory acquisition. Additionally, when the platform was removed, the untreated AD mice spent 87% of their time away from the target area, while TGR-63-treated mice spent only 66% of their time away. TGR-63-treated mice also spent more time in the target area, showing improved spatial memory retrieval.

IGC Pharma is currently underway with a Phase 2b trial in the United States and Canada evaluating IGC-AD1 for agitation in Alzheimer's. The trial encompasses 146 patients, with half assigned to the treated group receiving IGC-AD1, while the other half, the control group, receiving a placebo.

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 in 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 interactions with cannabinoids.

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/20240228605279/en/

Investors

IMS Investor Relations

Rosalyn Christian

igc@imsinvestorrelations.com

(203) 972-9200

Media

JVPRNY

Janet Vasquez

jvasquez@jvprny.com

(212) 645-5498

Source: IGC Pharma, Inc.

FAQ

What did IGC Pharma announce regarding Alzheimer's disease?

IGC Pharma announced positive results from preclinical studies on drug candidate TGR-63 for Alzheimer's disease.

What were the key findings of the preclinical studies on TGR-63?

The studies demonstrated enhanced memory function in an Alzheimer's mouse model, including improved memory acquisition, consolidation, and retrieval.

How does TGR-63 target Alzheimer's disease?

TGR-63 disrupts the structure of the amyloid-β (Aβ) peptide, mitigating symptoms like memory loss and disrupted learning ability.

What neuropathological hallmark of Alzheimer's Disease does TGR-63 target?

TGR-63 targets the misfolding and aggregation of Aβ peptides, specifically the toxic Aβ42 aggregation species associated with neuronal toxicity and cognitive decline.

Which behavioral tests were used to assess the cognitive impact of TGR-63?

The Novel Object Recognition (NOR) Test and the Morris Water Maze (MWM) were used to assess the cognitive impact of TGR-63.

Who commented on the results of the preclinical studies?

Ram Mukunda, CEO of IGC Pharma, commented on the results, highlighting the efficacy of TGR-63 in enhancing spatial memory function in Alzheimer's disease models.