Tuesday, IGC Pharma Inc IGC released interim data from its Phase 2 clinical trial of IGC-AD1 for agitation in dementia associated with Alzheimer’s.
The data demonstrates a clinically significant reduction, approaching statistical significance, in agitation in Alzheimer’s at week two compared to placebo.
IGC-AD1 targets neuroinflammation and CB1 receptor dysfunction, and the investigational drug contains THC as one of two active pharmaceutical agents.
“We are excited to share that the interim results on the secondary outcome show that IGC-AD1 can provide fast relief with few side effects in reducing agitation in Alzheimer’s dementia compared to placebo,” said Ram Mukunda, CEO of IGC Pharma.
“Approximately 6.5 million individuals in the U.S. live with Alzheimer’s and a majority experience a medical syndrome called agitation in Alzheimer’s dementia…The interim data indicate early signs of potential clinical benefit with IGC-AD1 with infrequent treatment-limiting side effects,” added Mukunda.
The secondary outcome, as measured by the change in agitation versus placebo using a standard measurement scale, the Cohen Mansfield Agitation Inventory (CMAI) at baseline and week 2, exhibited an Effect Size (ES) of 0.79 (p=0.071), indicating a large magnitude of difference between the active and placebo groups.
For context, a study published in 2003 concluded that an effect size over 0.5 corresponds to a noticeable change to a careful observer, highlighting the notable impact of IGC-AD1.
In May 2023, the FDA approved Otsuka Holding Co Ltd’s OTSKY OTSKF Rexulti (brexpiprazole), an atypical antipsychotic, with a boxed warning. This approval followed a significantly larger 12-week Phase 3 trial, which showed a Cohen’s d effect size of 0.35, whereas IGC-AD1 showed an effect size of 0.79 in two weeks.
The ongoing 146-patient clinical trial is a multicenter, double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer’s.
Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed.
Price Action: IGC shares are up 19.50% at $0.52 on the last check Tuesday.
Image: Wally Crawfish from Pixabay
