IGC Pharma, Inc. announced the results of an interim analysis of its ongoing Phase 2 trial investigating IGC-AD1 as a treatment for Agitation in dementia from Alzheimer?s Disease (?AAD?). The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer?s disease, indicating strong therapeutic potential for IGC-AD1. The study's primary goal is to assess the change in AAD after six weeks using a standard scale, the Cohen Mansfield Agitation Inventory (?CMAI?). Based on interim data, patients taking IGC-AD1, on average, experienced a more significant reduction in agitation scores compared to those on placebo, and the positive effects were observed as early as week two of the trial. At the primary outcome, assessing the change in agitation as measured by the CMAI at week 6, the Cohen?s d effect size indicating the superiority of IGC-ADI over placebo was 0.66. The CMAI Least Square (?LS?) mean difference between active, and placebo was -10.45, with a p-value of 0.037 (for combined week two and week six results). In addition, at the pre-specified secondary endpoint, change at week two, the effect size was 0.79. The Cohen?s d is a standardized statistical effect size that describes the magnitude of the difference between two groups, taking into account the variability in outcomes. The IGC-AD1 Phase 2 is an ongoing multi-site, randomized, double-blind, placebo-controlled clinical trial that continues to enroll. IGC-AD1 is an oral liquid formulation administered twice daily for six weeks with no placebo run-in and titration to full dose over two days. Agitation is rated at the trial site, at baseline, week 2, and week 6, by a trained practitioner using the CMAI, a scale designed to measure AAD. In 2023, the number of Americans living with Alzheimer?s was estimated at 6.7 million. According to one estimate, as many as 76% of them suffer from AAD (Van der Mussele et al., 2015), which is associated with an accelerated cognitive decline, increased caregiver burden, increased hospitalization, and increased need for medication, all significantly diminishing the quality of life for patients. Current therapies carry black box warnings, indicative of serious adverse reactions that may lead to death or serious injury. IGC-AD1 is designed to target AAD?s underlying causes and address the unmet need for a safe and effective therapy.

Neuroinflammation, neurotransmitter imbalance, and CB1 receptor dysfunctions are all associated with agitation in Alzheimer?s disease (Yasuno et al., 2023; Manuel et al., 2014). In addition, upregulation of inflammasome-3 has been shown to lead to neuroinflammation, consequently leading to aggressive behavior (Yu et al., 2023). IGC-AD1?s formulation combines a CB1 receptor partial agonist with anti-neuroinflammatory properties that help balance neurotransmitter imbalance and an inflammasome inhibitor that targets the upregulation of inflammasome-3.