MGC Pharmaceuticals (ASX:MXC), a company specialising in the production and development of phytocannabinoid-derived medicines, has announced that the phase 3 clinical trial evaluating the efficacy and safety of CimetrATM as a treatment for hospitalised patients diagnosed with COVID-19 has commenced following the recruitment of the first patient at the Rambam Medical Center in Israel.
The company says the trial follows the completion of CimetrA IMP production and validation and ethics committee approval. The Trial will enrol a total of 252 patients for 28 days per patient.
MGC Pharma said that now the trial has commenced, it will complete the required clinical data for meeting the European Medicines Agency’s (EMA) qualification and will look to submit additional pre-clinical and dose-finding studies to meet all requirements with the phase III study results.
The company said the trial is designed to test CimetrATM on moderate hospitalised patients infected with COVID-19 for safety and efficacy, with the purpose of treating the pathophysiological repercussions of infection with the novel coronavirus 2019 (SARS-CoV19).
According to Roby Zomer, co-founder and managing director of MGC Pharma, “The commencement of the Phase III clinical trial is a milestone achievement for both MGC Pharma and the medicinal cannabis industry. Testing CimetrATM as an IMP will have great implications for those suffering with COVID-19 and ensure the risk of healthcare systems becoming overwhelmed is minimised.”