IGC Pharma Advances In Alzheimer’s Research From Pre-clinical Studies To Phase Two Trial With Its Novel Therapy Candidate IGC-AD1

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By Faith Ashmore, Benzinga

Alzheimer's disease, a progressive neurological disorder, affects around 24 million individuals worldwide. It is characterized by memory loss, cognitive decline and behavioral changes. The impact of Alzheimers disease makes it a major healthcare challenge.

In 2023, Alzheimers and other types of dementia were projected to cost the U.S. $345 billion. By 2050, these costs could rise to nearly $1 trillion. While no cure currently exists for Alzheimer's, promising advancements in research and treatment are bringing hope to patients and their families.

Hope On The Horizon?

IGC Pharma (AMEX: IGC) is one of the companies hoping to provide solutions for millions of suffering Americans. It is a pharmaceutical company focused on developing innovative therapies for various medical conditions and fields, including Alzheimer's disease, chronic pain and womens health. The company specializes in advanced formulas and the companys lead drug candidate is IGC-AD1.

IGC-AD1 is undergoing extensive clinical trials to evaluate its effectiveness and safety in treating Alzheimer's disease. The phase two clinical trial, initiated in 2023, encompasses 20 sites across the United States and Canada. With a target of 146 participants, this trial focuses on determining the efficacy of IGC-AD1 in alleviating agitation, a common symptom experienced by many Alzheimer's patients. IGC-AD1 has patent protection for its unique formulation, which involves a combination of two Active Pharmaceutical Ingredients (APIs). This combination is administered as an oral liquid solution, making it more accessible and convenient for patients.

Pre-clinical studies of IGC-AD1 have demonstrated its potential in reducing the production of A40 peptide and inhibiting the aggregation of A42, both of which are associated with Alzheimer's. During phase one trials, patients with mild to severe Alzheimer's disease participated in a double-blind trial, where IGC-AD1 was administered at three different doses over a period of 14 days. The results were encouraging, as IGC-AD1 proved to be safe and well-tolerated by the participants, with no significant adverse effects reported. The study also demonstrated improvements in Neuropsychiatric Symptoms (NPS), specifically in the domains of agitation, anxiety and depression. These positive changes also led to a reduction in caregiver distress.

With the success of phase one trials, the company expects the phase two clinical trial to provide further insights into the efficacy and safety of IGC-AD1. As researchers and healthcare professionals continue to investigate this potential treatment, IGC-AD1 could bring hope to the millions of individuals living with Alzheimer's disease and their loved ones.

IGC Pharma also has four other drugs in the pipeline that are at the pre-clinal stage. TGR-63 targets early-moderate-stage Alzheimers and so far, has been shown to improve memory and learning in mice models at the pre-clinical stage. The other drugs in the companys pipeline are 1C, M3, and LMP, and it also has a variety of patents that focus on a wide range of targets, from eating disorders to epilepsy and more.

Featured photo by bruce mars on Unsplash

IGC Pharma Inc. (IGC) is at the forefront of the fight against Alzheimer's disease, developing innovative solutions 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 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, A plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2b clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting A plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of A plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is actively leveraging Artificial Intelligence (AI) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's.

These forward-looking statements are based largely on IGC Pharmas expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharmas control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Companys failure or inability to commercialize one or more of the Companys 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 FDAs general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharmas 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.

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