IGC Pharma Progresses Towards Phase 1 Alzheimer’s Clinical Trial

IGC Pharma is progressing towards a Phase 1 clinical trial for its proprietary Alzheimer's drug candidate, IGC-AD1, after demonstrating promising preclinical results. The trial will evaluate the safety, tolerability, and optimal dosing of the candidate in human subjects. The company said the candidate’s advancement into clinical trials will bring hope for a new therapeutic option in the battle against Alzheimer’s.

The following article originally appeared in Pharmaceutical Technology.

With positive preclinical data for its Alzheimer’s disease drug candidate TGR-63, IGC Pharma has announced that it plans to advance this small molecule into early clinical development in the course of 2024.

TGR-63 is an amyloid beta peptide-targeting drug designed to decrease plaque aggregation by preventing the misfolding and aggregation of amyloid-beta peptides. In the preclinical mouse models designed to assess behavioural responses in transgenic mice, subjects treated with TGR-63 demonstrated statistically significant reductions (43%) in overall movement as determined by an Open-Field behavioural test.

As per the 1 February press release, the data reinforces “its [TGR-63] potential as a promising treatment” for reducing levels of anxiety and improving emotional wellbeing.

The Timonium, Maryland-based pharmaceutical company is also actively evaluating its cannabinoid-based lead candidate IGC-AD1 as a treatment for Alzheimer’s dementia-associated agitation in a Phase IIb study (NCT05543681). In December 2023, the company announced a partnership with Los Andes University’s Center for Research and Training in Artificial Intelligence (CINFONIA) to incorporate generative AI analyses into the Phase II trial.

IGC Pharma is in the process of training algorithms with the goal of identifying clues for reducing misdiagnoses and false negatives, which is important as misdiagnoses and false negatives tend to be high in the Alzheimer’s indication, CEO Ram Mukunda told Pharmaceutical Technology. By addressing these issues, the company aims to improve trial success rates and ultimately accelerate the development and delivery of economic, effective treatments for Alzheimer’s patients, he adds.

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