- Believed to be the first natural low-doses of THC-based compound to enter human trials for Alzheimer’s
- IGC-AD1 has the potential to revolutionize the treatment of Alzheimer’s disease
- The clinical trial is expected to produce data to “help us to further understand the metabolism of IGC-AD1 for a diverse population,” says CEO
In a historic first, India Globalization Capital (NYSE American: IGC) has begun Phase 2 clinical trials evaluating its flagship drug candidate, IGC-AD1, for the treatment of agitation in dementia from Alzheimer’s disease (https://nnw.fm/Y1rLN). (https://cnw.fm/LGAZG). (https://ibn.fm/fg4A3). Company officials noted that, to their knowledge, this is the first natural low-dose THC-based compound to enter human trials for the treatment of symptoms such as agitation in dementia from Alzheimer’s disease. Currently there is no FDA-approved medication to treat agitation in Alzheimer’s.
“We believe IGC-AD1 has the potential to revolutionize the treatment of the symptoms (agitation) of Alzheimer’s disease as the only natural low-dose THC-based formulation candidate currently undergoing FDA testing,” said IGC CEO Ram Mukunda. “Approximately 8 million people are affected by Alzheimer’s in North America and over 55 million worldwide. We believe that the diverse population we have selected for this study will allow us to accurately look at both the impact of variations of the gene CYP2C9 that metabolizes THC, as well as the APOE e4 a gene that increases the risk of developing Alzheimer’s.
“This data will help us to further understand the metabolism of IGC-AD1 for a diverse population, which is important in a disease that has a global impact like Alzheimer’s,” Mukunda continued. “Through these and further trials, we look forward to establishing IGC-AD1’s efficacy in treating the symptoms related to Alzheimer’s disease.”
IGC’s Phase 2 trial, a multicenter, double-blind, randomized, placebo-controlled study of IGC-AD1, has started at two sites in the United States, with plans to add up to five additional sites throughout the U.S. and Canada; a site in South America is also being considered in order to increase population diversity and promote the inclusion of underrepresented populations.
According to the company, the trial will enroll 146 patients with one-half of participants, the “treated” group, receiving IGC-AD1, and the other half, the “control” group, receiving a placebo. “The goal of the trial is to evaluate and establish the efficacy of IGC-AD1 in helping patients with Alzheimer’s dementia reduce neuropsychiatric symptoms (‘NPS’) such as agitation, which effects 76% of individuals with Alzheimer’s,” the announcement stated. “Currently, there is no Food and Drug Administration (‘FDA’)-approved drug for treating agitation in dementia due to Alzheimer’s.”
According to the announcement, IGC-AD1 relies on low-doses of THC, a psychoactive cannabinoid, and another compound as active agents. In the Phase 1 clinical trials, the formulation demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques, a key hallmark of the disease.
India Globalization Capital develops advanced cannabinoid-based formulations for treating diseases, including but not limited to Alzheimer’s disease, Parkinson’s disease, chronic pain, and even pet seizures. The company sells various brands of CBD-based consumer products, including Holief, which includes gummies and pain relief creams for women experiencing premenstrual syndrome and dysmenorrhea (period cramps), and Sunday Seltzer, which includes a CBD-infused energy beverage. The company operates facilities in the United States under Good Manufacturing Practices.
For more information, visit the company’s website at www.IGCPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to IGC are available in the company’s newsroom at https://nnw.fm/IGC https://ibn.fm/IGC https://cnw.fm/IGC
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