IGC Pharma Inc. (NYSE: IGC), which was formerly known as India Globalization Capital, announced Wednesday it plans to advance its drug candidate IGC-AD1 into clinical trials as a potential anti-amyloid treatment for Alzheimer’s disease.
The move follows recent FDA approvals of anti-amyloid drugs from Eli Lilly and Eisai/Biogen, signaling growing interest in therapies targeting amyloid plaques associated with Alzheimer’s.
“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,” IGC Pharma CEO Ram Mukunda said in a statement.
IGC-AD1 is an orally administered drug with patent protection. Preliminary data provided by the firm suggest it may reduce amyloid plaque aggregation by about 20% and decrease production by up to 40% in cell lines. The company claims IGC-AD1 preserves production of Amyloid Precursor Protein, potentially maintaining brain health.
New clinical trials focusing on disease modification are expected to begin in early 2025. IGC Pharma faces stiff competition in the Alzheimer’s treatment market, dominated by larger pharmaceutical companies with greater resources.
The company said it is also incorporating artificial intelligence into its drug development process, using AI models to predict biomarkers and optimize clinical trials.
“We hope to position IGC Pharma to deliver a breakthrough treatment in Alzheimer’s disease, driving substantial value for our shareholders,” Mukunda said.
IGC Pharma’s SEC filings noted uncertainties including regulatory challenges and commercialization hurdles.
The announcement comes after IGC Pharma found itself indirectly linked to a recent SEC case. In July, the SEC charged activist short seller Andrew Left and his firm Citron Capital with a $20 million scheme involving false stock recommendations. India Globalization Capital was one of the companies targeted in the scheme.
According to the SEC complaint, Left collaborated with Anson Funds to prepare bearish reports on IGC and another cannabis company in 2018, which allegedly led to significant stock price volatility for IGC.
Still, the company has had other regulatory issues in the past. In 2020, IGC Pharma settled charges with the SEC against Mukunda for misstating in a press release that its first cannabis-based product was ready for sale.
IGC Pharma reported $1.3 million in revenue for fiscal 2024, up from $911,000 in fiscal 2023.