IGC Pharma announces additional interim data from IGC-AD1 trial

IGC Pharma (IGC) announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on agitation in Alzheimer’s as its primary outcome, with cognition assessed as an exploratory outcome. Interim data analysis reveals cognitive improvements in the active treatment group versus the placebo group, marking a meaningful step toward developing a therapy that may influence underlying disease progression. These findings align with previously announced preclinical data, which showed a reduction in amyloid plaque aggregation by approximately 20% and improved spatial memory by about 50% in Alzheimer’s cell lines and mouse models, respectively. Cognitive decline in Alzheimer’s disease reflects the deterioration of memory, attention, language, and reasoning due to underlying pathological changes, such as amyloid plaques and tau tangles. Interim results from the trial demonstrated that the active treatment group receiving IGC-AD1 twice daily for six weeks showed an average improvement of about 8% on the Mini-Mental State Examination, or MMSE, a validated clinical tool for assessing cognitive function. By contrast, the placebo group showed no improvement over the same period. These results and the preclinical data provide a robust foundation for future trials focusing on cognition as the primary endpoint and exploring IGC-AD1’s disease-modifying potential. Agitation, a debilitating symptom affecting up to 76% of Alzheimer’s patients, accelerates disease progression, increases caregiver burden, and drives hospitalization rates. As previously disclosed, interim results showed that IGC-AD1 significantly reduced agitation compared to placebo, with improvements observed as early as two weeks. Unlike the existing therapy, which often takes about 6-10 weeks to show results and carries a black box warning, IGC-AD1 offers rapid symptom relief with a favorable safety profile, making it a highly differentiated potential medication for managing agitation in Alzheimer’s.