IGC-AD1’s Interim Phase 2 Data Show a Reduction in Alzheimer’s Agitation at Week Two

IGC Pharma, Inc. (“IGC Pharma,” “IGC,” or the “Company”) (NYSE American: IGC) today announced that interim data from its Phase 2 clinical trial 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. THC is a principal psychoactive cannabinoid found in Cannabis. IGC-AD1 is a first-of-its-kind THC-based-formulation undergoing a formal Phase 2 clinical trial in Alzheimer’s disease (clinicaltrials.gov, Identifier: CT05543681).

“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. We are especially excited by these results given the limited therapeutic options currently available,” said Ram Mukunda, CEO of IGC Pharma.

“Alzheimer’s affects not only cognition but also mood and behavior that increase in intensity as the disease progresses. 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. There are various symptoms associated with this medical syndrome or condition such as screaming, pacing, biting, disrobing, excessive motor movements, physical aggression, and verbal aggression, among others. This medical condition makes it very difficult for caregivers to manage their loved one and is associated with increased hospitalization and accelerated cognitive decline.

“The interim data indicate early signs of potential clinical benefit with IGC-AD1 with infrequent treatment limiting side effects. We are encouraged by this data and will continue to work with the regulatory authorities on advancing IGC-AD1 through to commercialization,” 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 change that is noticeable to a careful observer, highlighting the notable impact of IGC-AD1. Further, in May 2023, the FDA approved 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, emphasizing, subject to further trials, the potential of IGC-AD1 as a treatment option.