IGC Pharma, Inc.(NYSE:IGC) reported additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1 for agitation in dementia associated with Alzheimer's disease. IGC-AD1 targets neuro-inflammation and CB1 receptor dysfunction,. The investigational drug contains THC as one of two active pharmaceutical agents.
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.
“The cognitive improvements observed in our interim results align with preclinical evidence of IGC-AD1’s active pharmaceutical ingredients’ impact on amyloid plaques and spatial memory," stated Ram Mukunda, CEO of IGC Pharma. "While agitation remains the primary focus of the Phase 2 trial, these exploratory findings strengthen our confidence in IGC-AD1’s potential to address the broader pathology of Alzheimer’s disease. For patients and caregivers, this potentially represents hope for improved care, and for our investors, it signifies a compelling opportunity in a growing market.”
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Cognitive Improvements
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, 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.
Primary Outcome: Agitation Reduction in Alzheimer’s Patients
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 up 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.
Alzheimer’s disease affects 6.7 million Americans, with the global Alzheimer’s treatment market projected to exceed $50 billion by 2025.
Price Action
IGC shares closed Monday market session 5.34% higher at $0.38 per share.
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