India Globalization Capital, Inc. IGC revealed the preliminary results of its exploratory endpoints from a Phase 1 clinical trial of a THC-drug to treat Alzheimer’s symptoms.
The Phase 1 clinical trial provided valuable insights on Pharmacokinetics (PK) and genotyping that will be essential in determining optimal dosing when moving into subsequent trials, subject to U.S. Food and Drug Administration (FDA) approval.
The THC-drug or IGC-AD1 is a proprietary cannabis-based investigational new drug candidate for patients suffering from Alzheimer's, which impacts about 50 million people worldwide, approximately 66% of whom are women. Unfortunately, there is no cure for Alzheimer’s and no FDA-approved pharmaceuticals to treat the many unpleasant symptoms, including agitation.
Clinical Trial Details
Pharmacokinetics studies how long it takes for the body to absorb, process, metabolize and eliminate a drug after being administered. In other words, it helps determine the appropriate and safe frequency of dosing.
The Phase 1 clinical trial results indicate that dosing two or three times per day may be safe for patients, as the first and potentially second dose would be eliminated from the body before subsequent doses are given.
Variations in the gene can impact the level of enzyme activity and how quickly the body metabolizes substances, including THC. These variations are stratified into groups of metabolizers - poor (PM), intermediate (IM), normal (NM), and ultra-rapid (UM). The trial used a blood test to determine that 62% of the study population were classified as IM and 38% NM. 100% of study participants were of Hispanic ethnicity.
The trial further revealed that optimal dosing frequency could vary based on a person’s polymorphism of the CYP2CP gene.
The company plans to use the results from this study to inform the design of Phase 2 and Phase 3 clinical trials, subject to FDA approval. IGC-AD1 is an investigational new drug that has not been approved as a medication by any regulatory body in any country. Although the Phase 1 trial has been completed, and certain data has been collected, IGC-AD1’s safety, tolerability and efficacy need to be further established through trials on larger and more diverse groups of Alzheimer’s patients.
IGC’s shares closed Wednesday market session 4.07% higher at $1.28 per share.
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