Island Pharmaceuticals says new data leads to ISLA-101 Phase 2 study changes

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Australian antiviral drug development company Island Pharmaceuticals (ASX:ILA) has announced new data expected to introduce significant, quantifiable time and cost savings into its clinical program for dengue fever.

In April, Island reported that its 24-patient single ascending dose study in ISLA-101 had successfully achieved all study outcomes relating to safety and dosing, which would enable it to move forward with the next steps regarding its Phase 2 study.

The company said new in silico dose modelling was conducted after the dose study closed. It said that while it initially expected to need to take a multiple ascending dose approach with its coming Phase 2 study, the modelled data confirms with specificity the single-level, multi-day dose of ISLA-101, which is predicted to achieve effective blood concentrations above those shown to be effective at arresting the dengue virus in prior pre-clinical studies.

CEO and managing director Dr David Foster said, “This final piece of data from the dose escalation study confirms what we’ve seen and reported to date. While we previously announced achieving the appropriate blood concentration following a single dose of ISLA-101, the results from this new modelling suggest that the blood concentration will increase upon repeat dosing, resulting in blood concentrations that exceed the concentration demonstrated to be effective in pre-clinical studies.