Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)

Complications of dengue infection follows the peak of viremia and are associated with increased activation of the immune response. Proof-of-concept studies in animal models of dengue infection have shown that blocking certain aspects of the inflammatory response or the administration of pro-resolving molecules is beneficial in experimental dengue. In these experiments, the administration of certain anti-inflammatory or pro-resolution molecules decreases disease severity and aspects of the inflammatory response, including changes in vascular permeability. We have previously shown that treatment with RESOMELAGON decreased lung inflammation and outcome in animal models of beta coronavirus infection (including by SARS-CoV-2) and decreased disease severity in COVID-19 patients, even in the presence of glucocorticoid therapy. Preclinical experiments also showed that RESOMELAGON decreased disease severity in an animal model of dengue infection and decreased cytokine release by human PBMC infected with dengue virus. RESOMELAGON is safe in healthy individuals, those with rheumatoid arthritis, and patients with COVID-19. This is a placebo controlled, randomized, double-blinded clinical trial evaluating the safety and efficacy of Resomelagon in patients with acute dengue infection.