India Globalization Capital Inc. (NASDAQ: IGC) stock plunged by 1.85% at last close whereas the IGC stock price gains by 22.01% in the after-hours trading session. India Globalization Capital is working on cannabinoid-based medicines for conditions like Alzheimer’s illness and pain. It is located in Potomac, Maryland, and works in two business lines: Infrastructure and Life Sciences.
IGC stock’ Significant Development
IGC’s cannabis-based investigational novel medication, IGC-AD1, for patients with severe Alzheimer’s disease, has completed its Phase 1 clinical trial, according to India Globalization Capital. IGC filed IGC-AD1 to the FDA under Section 505(i) of the Federal Food, Drug, and Cosmetic Act, as previously announced. On July 30, 2020, the FDA gave IGC permission to move forward with the Phase 1 trial.
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Safety and acceptability were the key outcomes of this Phase 1 experiment. The cannabis-based investigational medicine IGC-AD1 was relatively safe and well-tolerated by Alzheimer’s trial participants, according to this study, and subject to FDA approval. In IGC’s Annual Report, the FDA received the safety and tolerability data.
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 serious Alzheimer’s disease. Each participant was assigned a caregiver who assisted with daily reporting. The average age of participants in this Phase 1 trial was 80.9 years old, with an average weight of 141.2 pounds, and 66.7 percent of women and 33.3 percent of males.
Secondary endpoints of the experiment, such as pharmacokinetics, genotyping, neuropsychiatric inventory, and suicide intensity measurement, have also been achieved. They plan to release this information as soon as it becomes available and once it has been submitted to the FDA. At this point, there is no way of knowing what the conclusions of this secondary data will be or whether they will satisfy their expectations.
To the best of IGC’s knowledge, this is the first human clinical trial on Alzheimer’s patients employing low dosages of natural Tetrahydrocannabinol in combination with another drug. THC is a psychotropic part of the cannabis Sativa plant’s cannabinoid family of natural compounds. IGC anticipates that, if future successful results from acceptable more trials are approved by the FDA, IGC-AD1 will help some of the 50 million individuals worldwide who are estimated to be affected by Alzheimer’s disease by 2030. (WHO, 2020).