POTOMAC, Md.– IGC Pharma, Inc. (NYSE American: IGC) (“IGC Pharma” or the “Company”) announced today that the Company is advancing its proprietary formulation, IGC-AD1, toward clinical trials as a potential anti-amyloid disease-modifying treatment for Alzheimer’s disease.
Following the FDA’s 2023 approval of two groundbreaking anti-amyloid drugs, Donanemab (Eli Lilly) and Lecanemab (Eisai and Biogen), IGC Pharma is poised to make a significant contribution to this critical field with IGC-AD1. The recognition of amyloid-targeted therapies in slowing Alzheimer’s progression and improving cognitive function underscores the growing demand for innovative treatments. While the recent drug approvals have been a significant milestone in enhancing disease treatment, there is still an increasing demand for safe and effective treatments. IGC-AD1, an orally administered medication with a strong safety profile, potentially positions IGC Pharma favorably in this market landscape.
IGC-AD1, with its patent protection, represents a promising advancement in Alzheimer’s treatment. The APIs in IGC-AD1 have been shown to target amyloid plaques in Alzheimer’s cell lines through two mechanisms: a) inhibiting amyloid protein production and b) preventing its aggregation. Preliminary data from Alzheimer’s cell lines suggest that IGC-AD1 may reduce plaque aggregation by approximately 20% and decrease its production by up to 40% without affecting the production of Amyloid Precursor Protein (“APP”), which is essential for cell growth and survival.
Ram Mukunda, CEO of IGC Pharma, stated, “As we continue our ongoing Phase 2 clinical trials for treating agitation in Alzheimer’s dementia with IGC-AD1, we’re excited to advance our research into its potential as an anti-amyloid disease-modifying treatment. Evidence from cell lines suggests that IGC-AD1 may reduce amyloid levels while preserving APP production, a critical factor for brain health. With Phase 1 and Phase 2 interim safety and tolerability data, IGC-AD1 stands out as a differentiated drug candidate. The initiation of disease-modifying investigational trials, expected in early 2025, will open a significant market opportunity for IGC Pharma.
“By initiating new trials focused on IGC-AD1’s ability to modify amyloid plaque progression, we hope to position IGC Pharma to deliver a breakthrough treatment in Alzheimer’s disease, driving substantial value for our shareholders.”