IGC Pharma, Inc. (NYSE American: IGC), situated in Potomac, Maryland, revealed its plans to advance its proprietary formulation, IGC-AD1, into clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer's disease.
Following the U.S. FDA's 2023 approval of two significant anti-amyloid drugs, Donanemab by Eli Lilly and Lecanemab by Eisai and Biogen, IGC Pharma is prepared to contribute notably to this essential field with IGC-AD1. The recognition of amyloid-targeting therapies in decelerating Alzheimer's progression and enhancing cognitive function highlights the increasing demand for innovative treatments. Despite the recent approvals marking a milestone in disease treatment, there remains a need for safe and effective solutions. IGC-AD1, an orally administered medication with a robust safety profile, is poised to position IGC Pharma favorably within this market.
IGC-AD1, which is protected by patents, represents a promising development in Alzheimer's treatment. The active pharmaceutical ingredients (APIs) in IGC-AD1 have demonstrated the ability to target amyloid plaques in Alzheimer's cell lines via two mechanisms: inhibiting amyloid protein production and preventing its aggregation. Initial data from Alzheimer's cell lines indicate that IGC-AD1 may reduce plaque aggregation by around 20% and decrease its production by up to 40%, without interfering with the production of Amyloid Precursor Protein (APP), which is vital for cell growth and survival.
Ram Mukunda, CEO of IGC Pharma, expressed, "As we progress with our ongoing Phase 2 clinical trials for addressing agitation in Alzheimer's dementia with IGC-AD1, we are enthusiastic about advancing our research into its potential as an anti-amyloid disease-modifying treatment. Evidence from cell lines suggests that IGC-AD1 may lower amyloid levels while preserving APP production, which is crucial for brain health. With Phase 1 and Phase 2 interim safety and tolerability data, IGC-AD1 distinguishes itself as a unique drug candidate. The commencement of disease-modifying investigational trials, anticipated in early 2025, will present a significant market opportunity for IGC Pharma."
"By initiating new trials focused on IGC-AD1's capability to modify amyloid plaque progression, we aim to position IGC Pharma to deliver a breakthrough treatment for Alzheimer's disease, thereby driving substantial value for our shareholders," Mukunda added.
IGC Pharma operates as an AI-powered, clinical-stage biotechnology company dedicated to developing innovative treatments for Alzheimer's disease and transforming patient care with rapid, safe, and effective solutions. The company's portfolio includes the TGR family, such as TGR-63, which targets amyloid plaques, a hallmark of Alzheimer's. Additionally, the IGC-C and IGC-M platforms are advancing in preclinical studies, concentrating on metabolic disorders, tau proteins, early plaque formation, and various disease hallmarks.
The company's lead therapeutic candidate, IGC-AD1, a cannabinoid-based treatment, is currently undergoing a Phase 2 trial for agitation in dementia associated with Alzheimer's. Interim data for IGC-AD1 demonstrated its potential to revolutionize patient care by offering faster and more effective relief compared to traditional medications. Furthermore, IGC Pharma's AI models are designed to predict potential biomarkers for early Alzheimer's detection, optimize clinical trials, and forecast receptor affinity, among other applications.
With 28 patent filings and a commitment to innovation, IGC Pharma is dedicated to advancing pharmaceutical treatments and improving the lives of those affected by Alzheimer's and related conditions.
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