India Globalization Capital, Inc. Completes the Final Cohort of its Phase 1 Clinical Trial on Alzheimer’s Patients
June 23, 2021 at 06:50 pm EDT
Share
India Globalization Capital, Inc. announced that it has completed Cohort 3 of its Phase 1 clinical trial on IGC’s tetrahydrocannabinol (THC)-based investigational new drug, IGC-AD1, intended to alleviate the symptoms of individuals suffering from Alzheimer’s disease. As previously disclosed, IGC submitted IGC-AD1, its investigational drug candidate for Alzheimer’s, to the U.S. Food and Drug Administration (“FDA”) under Section 505(i) of the Federal Food, Drug, and Cosmetic Act. IGC received approval to proceed with the Phase 1 trial, on Alzheimer’s patients, from the FDA on July 30, 2020. Cohort 3 is the final cohort in IGC’s Alzheimer’s Phase 1 trial. The Data and Safety Monitoring Committee (DSMC) for IGC’s clinical trial will review the data from Cohort 3, and IGC will report its findings from all three Cohorts to the FDA. As previously announced, for Cohort 1, administered one dose of the investigational new drug IGC-AD1 per day to Alzheimer’s patients, which increased to two doses in Cohort 2 for the same Alzheimer’s patients, and to three doses in Cohort 3. This Phase 1 trial focuses on the safety and tolerability of IGC-AD1 on patients suffering from mild to severe Alzheimer’s. Daily, monitored and recorded certain solicited adverse events, such as somnolence, falls, dizziness, asthenia, suicidal ideation, hypotension, hypertension, psychiatric symptoms, seizures, paradoxical nausea and vomiting. Monitored unsolicited adverse events such as urinary tract infections and other abnormalities. All adverse events were tabulated and measured using a severity scale and compared against trial halting rules. To IGC’s knowledge, this is the first human clinical trial using low doses of natural THC, a psychoactive member of the cannabinoid class of natural products produced by the Cannabis sativa plant, on Alzheimer’s patients. Motivated by the potential that, with future successful results from appropriate further trials, IGC-AD1 could contribute to relief for some of the 50 million people around the world expected to be impacted by Alzheimer's disease by 2030 (WHO, 2020).
IGC Pharma, Inc. is a clinical-stage pharmaceutical company. It develops advanced cannabinoid-based formulations for treating diseases and conditions, including, but not limited to, Alzheimerâs disease, period cramps, premenstrual syndrome, and chronic pain. Its segments include Life Sciences and Infrastructure. It has two investigational drug assets targeting Alzheimerâs disease, IGC-AD1 and TGR-63, which have demonstrated in Alzheimerâs cell lines the potential to be effective in suppressing or ameliorating key hallmarks of Alzheimerâs disease, such as plaques or tangles. IGC-AD1 is a low-dose tetrahydrocannabinol (THC) based formulation that is in a 146-person phase II clinical trial for agitation in dementia due to Alzheimerâs. TGR-63, a non-cannabinoid molecule, is an enzyme inhibitor shown in pre-clinical trials to reduce neurotoxicity in Alzheimerâs cell lines. It also markets a wellness brand, Holief, that targets women experiencing premenstrual syndrome and menstrual cramps.
IGC PHARMA, INC. 
