A novel broad-spectrum antiviral in preparation for a pandemic enterovirus

Purpose and goal The goal is to conduct a phase I trial to evaluate the safety and pharmacokinetics of CUR-N399, a broadspectrum antiviral with effect on enterovirus (EV), a large group of human pathogenic viruses, and RSV. EV has been pointed out as a possible cause of the next pandemic and is in similarity to coronavirus, RNA virus that mutates easily, replicates quickly and can transmit from asymptomatic subjects. There is no antiviral drug approved for EV. An advantage of CUR-N399 is that it targets a cellular target giving a broad antiviral effect and high treshold for development of viral resistance. Expected results and effects We expect to demonstrate that CUR-N399 is safe and tolerable at clinically relevant doses and that its pharmacokinetic and dynamic profiles enables continued evaluation in clinical phase II. Successful development of CUR-N399 might contribute to better preparedness for future pandemics, reduced transmission, morbidity and death due to EV and RSV infections. For the society, CUR-N399 might contribute to reduced economic effects of these infections both in and without a pandemic and in the long run also to reduced poverty and increased equality. Planned approach and implementation The project is coordinated and carried out in collaboration between the two project partners Curovir AB and Sahlgrenska University Hospital, represented by Prof. Tomas Bergström. The project consists of four subprojects 1) manufacture of the active substance CUR-N399, 2) manufacture of clinical trial material (incl. Placebo), 3) remaining toxicity studies required for phase I, 4) clinical phase I study. The subprojects are carried out with the help of one Swedish and two Indian CRO companies, CTC Clinical Trial Consultants AB, Anthem Biosciences Pvt Ltd and GVK BioSciences Pvt Ltd.