Another patent for a cannabinoid-based cream to treat pain has been granted to IGC.
Pre-market, India Globalization Capital's stock price jumped by almost 15%. Investors have reacted favorably to India Globalization Capital's announcement that its Phase 1 clinical trial on IGC's cannabis-based investigational novel medicine IGC-AD1 for Alzheimer's disease patients has been completed.
IGC also submitted IGC-AD1 to the FDA under Section 505(i) of the Federal Food, Drug, and Cosmetic Act, as previously stated. On July 30, 2020, the FDA gave IGC permission to proceed with the Phase 1 trial.
The Phase 1 trial's primary outcome was safety and tolerability. And, based on this research, the cannabis-based investigational medicine IGC-AD1 was found to be safe and well-tolerated by Alzheimer's trial participants, subject to FDA approval. The FDA received the safety and tolerability data in IGC's Annual Report.
A total of 12 people with Alzheimer's disease took part in the study. The participants are a fragile geriatric population with a variety of comorbidities as well as mild to moderate Alzheimer's disease.
The average age of the participants in this Phase 1 trial was 80.9 years old, with an average weight of 141.2 pounds, with 66.7 percent of women and 33.3 percent of men.
At this point, there is no way of knowing what the conclusions of this secondary data will be or whether they will satisfy our expectations.
To the best of IGC's knowledge, this is the first human clinical investigation on Alzheimer's patients employing low dosages of natural Tetrahydrocannabinol (THC) in combination with another drug. THC is a psychotropic part of the cannabis sativa plant's cannabinoid family of natural compounds.