Potomac -
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.
Pre-Specified Interim Results
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.
'We are excited with the positive interim results from the Phase 2 trial of IGC-AD1 for agitation in dementia due to Alzheimer's disease. IGC-AD1's interim results demonstrate a clinical and statistically significant reduction in agitation compared to placebo, suggesting a strong plausibility to address a substantial unmet medical need. This interim data validates IGC-AD1's potential as a transformative therapeutic option with a large market opportunity in Alzheimer's disease management. We are actively pursuing next steps, including with regulators, and remain committed to advancing IGC-AD1 toward commercialization. We foresee a medication that can help alleviate caregiver burden and family distress as managing Alzheimer's patients, especially ones with agitation, can have a significant emotional toll on families. 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
Comparison with Existing Treatment
In
IGC-AD1 as a Treatment for Agitation in Alzheimer's Disease
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 (
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.
The 146-pateint IGC-AD1 trial, for which these interim results are presented, continues to enroll in the
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Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the
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