Australian antiviral drug development company, Island Pharmaceuticals (ASX:ILA) recently announced highly encouraging pharmacokinetics (PK) data from its ISLA-101 Single Ascending Dose study. ISLA-101 is a well-known drug candidate, being repurposed for the prevention and treatment of dengue fever and other mosquito (or vector) borne diseases. This new ISLA-101 PK data from the 24-subject study, is critical for determining how the drug acts in the body and for establishing appropriate dosing regimens for Island’s planned Phase 2a clinical trial.
Highlights:
• Island reports positive pharmacokinetic data and reconfirms strong safety / tolerability data for ISLA-101 from its 24-subject Single Ascending Dose clinical study
• Data analysis shows required levels of ISLA-101 concentration in the blood were observed after only a single dose, achieving the study’s purpose
• This important new data is being used to prepare for Island’s planned Phase 2a clinical trial in dengue fever
Commentary:
CEO of Island Pharmaceuticals, Dr David Foster said, “This new pharmacokinetic data reinforces our strong confidence in ISLA-101. The data has shown us that even following a single dose, we are achieving blood concentrations that have previously been shown to be effective against dengue fever infections. This is exactly the outcome we hoped for – it provides a critical datapoint to underpin our dosing regimen as we prepare for the Phase 2 clinical study, which will include dosing for multiple days.” “We would expect from first principles to see the concentration levels increase with multiple days of dosing and this will be examined in PK modelling work that is currently being completed. We are very pleased with the outcomes of this study. It not only confirms we have an appropriate plan as we head toward Phase 2, but it has helped to build our experience with the drug, manufactured at today’s standards and in a modern clinical setting.”