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IGC Pharma, Inc. (IGC), a leading cannabinoid-based formulation developer, has expanded its Phase 2 clinical trial for IGC-AD1, a natural THC-based investigational drug for Alzheimer's disease, to the University of Puerto Rico network.
IGC is dedicated to developing advanced cannabinoid-based formulations for a range of diseases, including Alzheimer's, dysmenorrhea, PMS and chronic pain.
“We are excited to announce our partnership with the University of Puerto Rico, a remarkable institution conducting world-leading medical research. The addition of this site with individuals living with Alzheimer’s from the Hispanic community is a significant milestone in our Phase 2 trial. Alzheimer’s disease, including the resulting symptom of agitation, is complex to treat and incredibly hard to live with,” Ram Mukunda, CEO of IGC Pharma said in a press release.
"According to clinicaltrials.gov, IGC-AD1 is the only natural THC-based investigational drug undergoing FDA trials," per the release.
Their therapy, which involves low doses of THC and another compound, has shown promise in pre-clinical studies for improving Aβ plaques and reducing neuropsychiatric symptoms in Alzheimer's-related dementia.
The Phase 2 trial's expansion to Puerto Rico aims to increase population diversity and the representation of underrepresented groups.
Dr. Vanessa Sepúlveda-Rivera, principal investigator for the University of Puerto Rico trial, emphasized the importance of including Hispanic populations in medical research, given the higher prevalence of Alzheimer's in Puerto Rico compared to the continental U.S. population.
With plans to add sites in South America and Canada, the trial will enroll 146 patients, half of whom will receive IGC-AD1 and the other half a placebo.
The goal is to evaluate the drug's efficacy in reducing agitation, a symptom affecting 76% of Alzheimer's patients.
IGC has developed proprietary compounds, IGC-AD1 and TGR-63.
IGC-AD1, a low-dose THC-based formulation, is currently undergoing a Phase 2 clinical trial with the identifier NCT05543681 on clinicaltrials.gov.
IGC also markets the wellness brand Holief, catering to women dealing with premenstrual syndrome and menstrual cramps.
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