IGC Pharma has reported encouraging interim results from its ongoing Phase II CALMA trial (NCT05543681) of IGC-AD1, an investigational treatment for agitation in dementia related to Alzheimer’s disease.
Based on the interim analysis, patients experienced a 71% reduction in the number of sleep disturbances by the end of the second week of the study. By the end of the sixth week, that figure climbed to 78%. These results were measured using the Neuropsychiatric Inventory (NPI-12) Sleep Subscale, a ten-item scale designed to assess neuropsychiatric symptoms in individuals with dementia.
Go deeper with GlobalData
IGC-AD1 is a cannabinoid-based partial CB1 receptor agonist designed to target neuroinflammation. Research by the Mayo Clinic estimates that sleep troubles impact up to 25% of people with mild to moderate Alzheimer’s, and approximately 50% of people with moderate to severe Alzheimer’s with symptoms often growing worse as the disease progresses.
IGC Pharma CEO Ram Mukunda said: “IGC-AD1’s ability to improve sleep quality in Alzheimer’s patients is very exciting. Better sleep is linked to reduced agitation and caregiver distress, as well as slowing cognitive decline and improving overall quality of life.”
Additional research published in the Proceedings of the National Academy of Sciences of the United States of America found that one night of sleep deprivation, relative to baseline, resulted in a significant increase in amyloid burden in the right hippocampus and thalamus, worsening symptoms in patients.
The company is facing steep competition, with GlobalData’s Pharmaceutical Intelligence Center detailing how there are 829 therapies aimed at agitation in Alzheimer’s dementia. In this space, the overall global market brought in more than $2.8bn in 2024, with that figure predicted to rise to more than $4.9bn by the end of the decade. The market is mostly dominated by Otsuka Holdings’ Rexulti, bringing in $1.8bn in 2024.
GlobalData is the parent company of Clinical Trials Arena.
The announcement comes ahead of the 2025 AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders. Elsewhere in the field of Alzheimer’s disease research, Cassava Sciences has officially stopped the development of its investigational drug simufilam after it failed to show benefit in a second Phase III trial. Meanwhile, Roche’s discontinued drug gantenerumab could drop the risk of developing symptoms by 50%.
