Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection.
Arboviral infections are caused by a group of viruses spread to people by the bite of infected arthropods (insects) such as mosquitoes and ticks. Arboviral infections are no longer exclusive to the Global South but are going to become more common also in the Global North.
The most prevalent arboviral disease is dengue fever. Other arboviral disorders include chikungunya virus, Zika virus, yellow fever, Japanese encephalitis, and West Nile virus.
Serious complications of post-infection may occur and are due to a deregulated immune response (hyper inflammation), which can lead to internal bleeding and organ damage.
Infections with Dengue virus have already been reported in Italy, France, Spain and Greece. Severe infections bring serious morbidity in a proportion of patients and can be lethal on re-infection.
Preclinical evaluation of resomelagon ability to modulate the inflammatory response and restoring the balance (hemostasis) of the immune system to arbo-virus, including Dengue virus supports the possibility to apply resomelagon in a clinical setting.
As a part of the RESOVIR collaboration the RESOVIR-2 investigator initiated study has been initiated at sites in Brazil. The study aims to demonstrate safety and a clinical proof-of-concept of host-directed treatment with resomelagon as an add-on treatment to conventional symptomatic treatment of virus-induced inflammation, in patients with dengue fever. Patient enrollment with be conducted at the next epidemic at sites.
The RESOVIR-2study is a randomized placebo-controlled, phase IIa study testing once daily oral dose of Resomelagon (AP1189) vs placebo (1:1 randomization, n=120) in patients with symptomatic dengue.
The potential effect will be evaluated by time to disease resolution by a composite clinical end point. Other clinical end points including the ability to reduce the incidence of warning signs of and/or the development of severe dengue will also be evaluated.