Pharma Focus Europe

IGC Pharma Extends Phase 2 Trial of IGC-AD1 to Include Collaboration with the University of Puerto Rico

Thursday, August 03, 2023

IGC Pharma, Inc (NYSE American: IGC) announced the addition of a trial site at the University of Puerto Rico network to expand its ongoing Phase 2 clinical trial investigating IGC-AD1, the company's lead drug asset. The trial aims to evaluate IGC-AD1's efficacy as a treatment for reducing agitation in Alzheimer's disease patients.

IGC-AD1 is a natural THC-based investigational drug undergoing FDA trials. It utilizes low doses of THC and another compound to target Alzheimer's disease, showing potential in pre-clinical studies to ameliorate Aβ plaques and reduce neuropsychiatric symptoms, including agitation, based on Phase 1 results.

The expansion of the trial to Puerto Rico aims to increase population diversity and promote the inclusion of underrepresented communities. The company plans to add future sites in South America and Canada to further enhance diversity. The trial will enroll 146 patients, half of whom will receive IGC-AD1, while the other half will receive a placebo. The primary goal is to assess IGC-AD1's effectiveness in reducing neuropsychiatric symptoms, such as agitation, which affects 76% of individuals with Alzheimer's.

Dr. Vanessa Sepúlveda-Rivera, Principal Investigator for the University of Puerto Rico trial sites, emphasized the importance of including Hispanic populations in medical research, considering the higher prevalence of Alzheimer's in Puerto Rico compared to the continental U.S. The collaboration with the University of Puerto Rico is a significant milestone in IGC's Phase 2 trial, involving individuals from the Hispanic community affected by Alzheimer's.

Ram Mukunda, Chief Executive Officer of IGC Pharma, Inc., expressed enthusiasm about the partnership with the University of Puerto Rico and acknowledged the complexity of treating Alzheimer's disease, especially its challenging symptom of agitation. The company is dedicated to finding effective therapies for this condition.

In summary, IGC Pharma's expansion of its Phase 2 trial to Puerto Rico is a crucial step in investigating the potential of IGC-AD1, a THC-based drug, to treat agitation in Alzheimer's patients. The inclusion of diverse populations is essential to ensure reliable data and develop more effective treatments for this challenging disease.

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