This study, which will enroll 40 healthy adults in U.S. sites, follows a successful Phase 1a single ascending dose clinical study completed in 2016. Preclinical studies have shown that UV-4B is active in vitro against all four dengue virus subtypes and in vivo studies have shown improved survival even when dosing was delayed by up to 48 hours post-infection.
Emergent BioSolutions biodefense division executive vice president and president Adam Havey, said: “Emergent is pleased to announce the initiation of our Phase 1b clinical study. With Emergent’s sharpened focus on preventing and treating public health threats and emerging infectious diseases, we will leverage our growing anti-infectives platform technologies and expertise in development and manufacturing to help find solutions to these threats.”
UV-4B is the lead dengue virus therapeutic candidate in Emergent’s iminosugar library. Iminosugars are small molecule therapeutics that target host glycosidase enzymes leading to reduced virus infectivity in multiple viruses such as dengue, Zika, SARS, and influenza.
This novel host-based mechanism of action allows the potential for broad-spectrum application and a reduced probability of developing drug resistance.
According to the Centers for Disease Control and Prevention, dengue is a leading cause of illness and death in the tropics and subtropics. There are 100 endemic countries with 400 million new infections annually. Currently, there are no available treatments for dengue.
This study is fully funded under development contract HHSN272201100030C with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health of the U.S. Department of Health and Human Services.