Wednesday, IGC Pharma Inc ( IGC ) announced the results of an interim analysis of its ongoing Phase 2 trial of IGC-AD1 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.

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. 

Cohen’s d is a standardized statistical effect size that describes the magnitude of the difference between two groups, considering the variability in outcomes.

In May 2023, the FDA approved Otsuka Holding Co Ltd’s (OTC:OTSKY) (OTC:OTSKF) Rexulti (brexpiprazole), an atypical antipsychotic, with a boxed warning. 

The approval followed a significantly larger 12-week Phase 3 trial, which showed a difference in LS mean from baseline CMAI between active and placebo of -5.32, a Cohen’s d effect size of 0.35, and a p-value of 0.003.

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.

The 146-patient IGC-AD1 trial, for which these interim results are presented, continues to enroll in the U.S. and Canada.

“With IGC-AD1’s promising clinical profile, we are confident in its ability, subject to further trials, to improve patient outcomes and drive shareholder value,” said Ram Mukunda, CEO of IGC Pharma ( IGC ).

Price Action: IGC shares are down 13.80% at $0.33 on the last check Wednesday.