POTOMAC, Md., April 16, 2024
–(BUSINESS WIRE)–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 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.
The ongoing 146-patient clinical trial is a multicenter, double-blind, randomized, placebo-controlled study designed to assess safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer’s. To date over 1,000 oral doses have been administered, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1.
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 FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.
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