Through the EU project, we will primarily deliver results of two clinical phase 2 trials, each with 400 patients/subjects recruited.
The first study will be for therapeutic efficacy and safety of OPN-019 (two dosages versus placebo for 14 days) in adult patients with COVID-19 either with mild illness (no oxygen required) or who are asymptomatic/presymtomatic, and eligible patients must have at least one additional risk factor such as >65 years of age, on treatment for hypertension and/or for diabetes type 2, have BMI >30 or be immunosuppressed.
The second study will investigate the efficacy and safety of OPN-019 (two dosages vs placebo) as prophylaxis against developing detectable infection in adult subjects who are negative for SARS-CoV-2 virus but who are at risk for infection due to cohabitation contact with a known-positive subject.
Another work package will be devoted to regulatory agency liaisoning; specifically to obtain scientific advice and negotiate agreement for the clinical development plan with the European Medicines Agency (EMA). Likewise we will present and agree the study protocol to national agencies in the EU/EEA countries in which we will run the two clinical trials.
A 4th work package will involve manufacturing upscale development for cGMP production for later phase 3 studies and commercial sales. In order to reduce overall risks, we plan to have both a European as well as an American manufacturing site so that sufficient quantities of the drug&device combination can be ascertained even for peak needs.