GCAN submitted a clinical trial application to the Israel Ministry of Health for approval of Phase 2 clinical trial of its novel neuropsychiatric cannabinoid-focused biopharmaceutical company, Greater Cannabis Company, Inc.
The company is looking to conduct a Phase 2 clinical trial led by the principal investigator, Dr. Adi Aran, to determine the safety and efficacy of its neuroprotective cannabinoid therapeutic to treat autism-related spectrum disorders ASD and other neuropsychiatric illnesses.
The study will consist of a double-blind, placebo-controlled trial with 100 patients aged 4 -- 17 years old. The researchers are expected to enroll patients in the first half of 2023, pending the approval of the Health Ministry, and to run for 12 to 18 months, including a possible open-label phase.
Aitan Zacharin, CEO of GCANRx, said that we are excited to take this next step in the advancement of our novel therapeutic to clinical trials. ASDs are common and lifelong neurodevelopmental disabilities that have a significant emotional and economic impact on the individual, family, and society. Despite worldwide efforts, there is no conventional pharmacological treatment for the core symptoms of ASD, leaving patients and families with an unmet need. Positive results in this study carry promise for a novel treatment for ASD as well as other neuropsychiatric disorders such as schizophrenia, Alzheimer's disease and Parkinson's disease, which share similar pathophysiological processes and can have an enormous impact on the lives of countless families as well as public health.