Benzinga | Nov 23, 2020 09:09AM EST

IGC Commences Phase 1 Of Cannabinoid Clinical Trial For Alzheimer's Patients

India Globalization Capital, Inc. ("IGC" or the "Company") (NYSE:IGC) announced that it is enrolling participants suffering from mild to severe dementia due to Alzheimer's disease for its Phase 1 clinical trial.

Our subsidiary, IGC Pharma, LLC, received approval from an Institutional Review Board ("IRB") as previously disclosed, engaged a Principal Investigator and a study site, and began enrolling participants for a Phase 1 trial on its Investigational Drug Candidate ("IDC"), IGC-AD1.

Our Phase 1 study is a placebo-controlled study. IGC-AD1 will be administered for three 14-day periods, with the dose escalated in each of the periods. The participants will be monitored daily, certain data will be collected, and while collection of safety data is the primary objective, we will, for research purposes, collect data that extends beyond safety. For example, we expect to collect data on how fast IGC-AD1 is absorbed through the body (pharmacokinetics), how long it lasts in the body, and whether different individuals process it differently based on polymorphisms of the liver enzyme CYP450 2C9. In addition, we will monitor, through tests, certain behavioral aspects brought on by dementia to help us in anticipated future phases of the study.

As previously reported, on July 30, 2020, IGC received notice from the U.S. Food and Drug Administration ("FDA") to proceed with a 12-subject Phase 1 human clinical trial ("removal of full clinical hold") on its Investigational New Drug Application ("INDA"), IGC-AD1, submitted under Section 505(i) of the federal Food, Drug, and Cosmetic Act.

To receive investigational drug approval as a pharmaceutical drug, the Sponsor (IGC Pharma, LLC) must conduct several trials and gather data. These typically start with pre-clinical trials that involve testing the IDC on cells outside of a living organism (in vitro), followed by animal testing. This in vitro and animal data was previously disclosed. Based on promising evidence, we are pursuing human trials, for which the FDA must give permission. Following Pre-INDA meeting correspondence in late 2018, we submitted an INDA to the FDA in November 2019. This process included presenting the results of in vitro and animal studies, safety data, a protocol outlining how a potential trial will be run, how data will be collected, how participant data will be protected, how IGC-AD1 will be made, who will make it, what is in it, data on the stability of the formulation, and details on the Chemistry, Manufacturing, and Controls (CMC). We also agreed a) to obtain an Informed Consent Form (ICF) from participants that would be reviewed and approved by an IRB, and b) to follow all rules required for studying IDCs, including those surrounding COVID-19.

While we cannot guarantee the time frame, taking into account the upcoming holidays and current restrictions brought on by COVID-19, we expect to complete the phase 1 study during the first half of calendar 2021.