India Globalization Capital, Inc. IGC announced Tuesday that it had received positive primary endpoint data for its Phase 1 clinical trial for IGC-AD1, which is a proprietary cannabinoid-based investigational new drug candidate for patients with Alzheimer's disease, which impacts about 50 million people worldwide, out of which roughly 66% are women.
The news came on the heels of the company's recent update on preliminary results from a Phase 1 clinical trial of a THC-drug to treat Alzheimer's symptoms. The results indicated 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. Moreover, the trial revealed that optimal dosing frequency could vary based on a person's polymorphism of the CYP2CP gene.
The company, based in Potomac, Maryland, confirmed that minimal adverse events were reported during the Phase 1 trial, and that IGC-AD1 was tolerated with no safety concerns identified by an independent Data Safety Monitoring Board.
The company's strategy with IGC-AD1 is to demonstrate safety and tolerability, then, subject to FDA approval, to test and show efficacy in a large and diverse trial focused on symptoms associated with dementia in Alzheimer's.
Clinical Trial Details
The trial was conducted as a multiple ascending dose study. The participants were a geriatric population with multiple comorbidities and mild to moderate Alzheimer's disease with an average age of 80.9 years. In addition, 66.7% of participants were women, and 33.3% were men.
It included three cohorts, with 12 patients in each cohort. Patients in cohort 1, cohort 2, and cohort 3 received one, two, and three doses of IGC-AD1 per day, respectively, for two weeks.
Considering that there were no serious or life-threatening AEs, the company is encouraged to design Phase 2 and Phase 3 clinical trials, subject to FDA approval.
IGC's shares traded 0.43% lower at $1.165 per share at the time of writing on Tuesday morning.
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