US-based specialist bio-pharmaceutical company Emergent BioSolutions has initiated the Phase Ib clinical trial of its anti-viral candidate UV-4B to treat dengue viral infection.
UV-4B is an iminosugar designed as an oral, broad spectrum antiviral to minimise virus infectivity by inhibiting a host glycosylation, which leads to misfolded viral glycoproteins.
Expected to enrol 40 healthy adults in the US sites, the multiple ascending dose Phase Ib trial is designed to evaluate the safety and tolerability of UV-4B.
Emergent BioSolutions bio-defence executive vice-president and president Adam Havey said: “Emergent is pleased to announce the initiation of our Phase Ib 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.”
The results from preclinical studies indicated that UV-4B is active in vitro against all four dengue virus subtypes, while the in vivo studies showed increased survival even when dosing was delayed by up to 48 hours post-infection.
The Phase Ia single ascending dose trial of the drug has been completed last year.
The study is fully funded by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health of the US Department of Health and Human Services.
Emergent BioSolutions develops, manufactures, and delivers medical remedies for biological and chemical threats, as well as emerging infectious diseases.