India Globalization Capital Inc. (NYSEAMERICAN: IGC) jumped 11.49% after the company announced the completion of Cohort 3 of phase 1 clinical study on its tetrahydrocannabinol (THC)-based experimental new drug, IGC-ADI, for alleviating Alzheimer’s disease symptoms.
FDA had approved IGC-ADI for Phase 1 study
The company previously disclosed that it had submitted IGC-AD1, their Alzheimer’s medication candidate, to the US Food and Drug Administration under Section 505(i) of the Federal Food, Drug, and Cosmetic Act. On July 30, 2020, the FDA gave IGC permission to proceed with the Phase 1 trial on Alzheimer’s patients. The Data and Safety Monitoring Committee will review the data from Cohort 3 for IGC’s clinical study, and the company will report findings to the FDA.
IGC had previously reported that the Alzheimer’s patients received one dose of the investigational novel medicine IGC-AD1 per day in Cohort 1. The company increased the drug to two doses in Cohort 2 and three doses in Cohort 3 for Alzheimer’s patients. The Phase 1 study examined the safety and tolerability of IGC-AD1 in patients with mild to moderate Alzheimer’s disease. Also, IGC tracked and recorded sleepiness, dizziness, falls, suicidal ideation, asthenia, hypotension, mental symptoms, hypertension, seizures, vomiting, and paradoxical nausea daily.
The company also monitored unintentional adverse events, such as urinary tract infections and other anomalies. Equally, a severity scale was used to record and grade adverse and then compared to halting trial criteria.
The first study on Alzheimer’s patients using THC
To the best of IGC’s knowledge, this is the first human clinical study on Alzheimer’s patients using modest dosages of natural THC. The company remains optimistic by the possibility that IGC-AD1 could help some of the 50 million people worldwide who are estimated to be affected by Alzheimer’s disease by 2030 if future successful results from relevant further trials are obtained.