IGC Pharma Reports Successful Trial for Alzheimer’s Agitation Drug

IGC Pharma, a company listed on the NYSE American stock exchange, has reported positive interim results from a Phase 2 clinical trial of their drug IGC-AD1, which is being developed to treat agitation associated with dementia caused by Alzheimer's disease. The drug showed a significant reduction in agitation symptoms compared to a placebo, as measured by the Cohen Mansfield Agitation Inventory (CMAI). The trial is an ongoing, multi-site, randomized, double-blind, placebo-controlled study.

The primary objective of the study was to evaluate the reduction in agitation over a period of six weeks using the CMAI scale. The interim data revealed that patients who received IGC-AD1 had a more pronounced decrease in agitation scores than those on a placebo, with noticeable improvements as early as the second week of the trial. The effect size indicating the drug's superiority over the placebo was 0.66, and the mean difference between the active treatment and placebo was -10.45 with a p-value of 0.037, suggesting a statistically significant result.

The ongoing trial involves an oral liquid formulation of IGC-AD1 administered twice daily for six weeks. Agitation is assessed by trained practitioners using the CMAI at the trial site at baseline, week 2, and week 6. The CEO of IGC Pharma, Ram Mukunda, expressed excitement over the interim results, stating that they validate the potential of IGC-AD1 as a transformative therapeutic option with a large market opportunity in Alzheimer's disease management.

The drug is designed to target the underlying causes of agitation in Alzheimer's disease, including neuroinflammation, neurotransmitter imbalance, and CB1 receptor dysfunctions. The formulation combines a CB1 receptor partial agonist with anti-neuroinflammatory properties and an inflammasome inhibitor targeting the upregulation of inflammasome-3.

It is important to note that the interim results are based on a small number of patients, and there is no guarantee that these positive findings will be sustained as more patients are enrolled in the trial. IGC Pharma is committed to advancing IGC-AD1 towards commercialization and believes that the drug has the potential to alleviate the burden on caregivers and families, as managing Alzheimer’s patients with agitation can be emotionally taxing.

The company is also developing other drug candidates targeting different aspects of Alzheimer's disease and is leveraging artificial intelligence for Alzheimer's research, including clinical trial optimization and early detection of the disease.