Island Pharmaceuticals’ Dengue Drug ISLA-101 Clears Phase 2a, Set to Begin Phase 2b in Early 2025

Island Pharmaceuticals Ltd. has reported promising results from the Phase 2a segment of its PROTECT Phase 2a/b trial, evaluating ISLA-101, a potential antiviral treatment for dengue fever. The Safety Review Committee (SRC) confirmed the drug's safety and observed antiviral activity against the dengue virus. Based on these findings, the SRC has recommended advancing to the Phase 2b therapeutic cohort. Island plans to submit this recommendation to the U.S. FDA, with a target start date for the Phase 2b study set for January 2025.

Dr. David Foster, CEO and Managing Director of Island Pharmaceuticals, expressed excitement about the progress, noting that the Phase 2a results validate the company’s original vision. He highlighted the SRC's unanimous conclusion that ISLA-101 is safe and effective in reducing dengue viral load. With the recent $3.5 million funding, Island is well-positioned to fully support the Phase 2b trial and continue developing additional treatments in its pipeline.

The Phase 2a trial involved administering ISLA-101 to participants before they were exposed to a weakened strain of the dengue virus developed by the U.S. Army. Data from the trial showed no safety concerns, with the drug reaching its intended blood concentration and demonstrating a reduction in viral load. Dr. Stephen Thomas, a member of the Island’s Scientific Advisory Board, emphasised the importance of the SRC's endorsement, stating that advancing to Phase 2b marks a significant step in evaluating ISLA-101’s potential to combat dengue fever. The company is now finalising its submission to the FDA and remains on track to begin the next phase of the trial in early 2025.