– The Company is targeting a Phase 1 trial in 2024 –
Potomac, MD, February 1, 2024 – IGC Pharma, Inc. (“IGC Pharma,” “IGC,” or the “Company”) (NYSE American: IGC) today announced additional positive results of preclinical studies investigating the Company’s newly announced therapeutic candidate, TGR-63, a potential treatment for Alzheimer’s disease. Previously disclosed results demonstrate that TGR-63 may successfully alleviate plaque burden in Alzheimer’s cell lines and animal models. Plaques are a key hallmark and therapeutic target of Alzheimer’s disease.
“While we continue to progress our Phase 2b trial of IGC-AD1 as a treatment for agitation in dementia due to Alzheimer’s, we are excited by the preclinical results of TGR-63, in particular the profound impact of the drug on plaques and on reducing anxiety in a transgenic Alzheimer’s mouse model. In line with IGC Pharma’s artificial intelligence and machine learning (“AI/ML”) initiatives, we plan to leverage cutting-edge AI/ML tools for studying TGR-63’s toxicology and protein interactions. By harnessing the power of AI/ML, we expect to accelerate the journey of TGR-63 from preclinical to patient care. We continue progressing IGC-AD1 and TGR-63 enthusiastically and anticipate clinical milestone updates throughout 2024 from our strengthened AD pipeline”, said CEO Ram Mukunda.
TGR-63 is a patent pending molecule designed to disrupt the structure of the amyloid beta (“A𝜷”) peptide, one of the key hallmarks of Alzheimer’s. TGR-63 targets plaques by addressing the misfolding and aggregation of amyloid-𝜷 peptides, specifically the toxic A𝜷42 aggregation species associated with neuronal toxicity and cognitive decline. Preclinical investigations also indicate a recovery of behavioral functions in an animal model of Alzheimer’s, suggesting that TGR-63 could possibly be used as a treatment for anxiety in human Alzheimer’s.
The preclinical trial was conducted on APP/PS1 (transgenic) mice that are genetically modified to carry mutations of the Amyloid Precursor Protein (APP) gene that lead to the production of a specific form of A𝜷 peptide, a key component of amyloid plaque in the brains of individuals with Alzheimer’s.
During the investigation, two groups of APP/PS1 mice undertook an Open-Field (“OF”) test, a behavioral assessment designed to measure anxiety-like behavior, stress and coping responses, and emotional state, among others, in rodent models.
The mice in the APP/PS1 group that received TGR-63 treatment showed significant improvements in their emotional well-being and anxiety levels compared to the group that didn’t receive treatment. A series of tests were used to measure these improvements. First, in the Open-Field (OF) test, the treated mice displayed a 43% reduction in their overall movement within the test area, which was highly statistically significant (p<.0001). They also showed a 59% reduction in movement within the central zone of the test area (p<.01). Additionally, in a more specialized analysis called the Center Zone Exploration (CZE) Analysis, the TGR-63 treated group exhibited a 55% improvement compared to the untreated group (p<.05). The results from these multiple tests indicate that TGR-63 treatment helped normalize emotional and behavioral responses in our Alzheimer’s mouse model, reinforcing its potential as a promising treatment.
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.
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, 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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