ISLA-101 Phase 2a/b PROTECT Clinical Trial Progress Update

Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to announce progress on its ISLA-101 Phase 2a/b clinical trial in dengue fever.

• All key data samples have been collected following dosing of all subjects in the Phase 2a (prophylactic) trial as part of Island’s ISLA-101 Phase 2a/b PROTECT clinical trial in dengue fever
  
• Data currently being consolidated for review by the Safety Review Committee (SRC) in the coming weeks
• On track to release SRC recommendation on advancing the trial to Phase 2b by end of this calendar year

Following the announcement (ASX: 3 October 2024) that all subjects in the Phase 2a cohort of the trial had been dosed, Island confirms it has now collected the required samples to analyse how the viremia (viral load) levels in the blood of trial subjects have changed through the study. Other samples are being analysed for pharmacokinetic data as well as other blood analyses.

This data is currently being consolidated for review by the Safety Review Committee (SRC), who will meet in the coming weeks. The SRC will evaluate the safety of ISLA-101 in dengue infected individuals and consider if there is evidence of anti-dengue activity. They will then make a recommendation regarding advancing the trial to the Phase 2b cohort before the end of the calendar year.

Island’s CEO and Managing Director, Dr David Foster commented, “We are very pleased to be able to report that 46 days into the trial, we’ve collected the key data required for evaluation by the Safety Review Committee. From here, while we will continue to check in with patients up to 90 days post dosing, we look forward to providing all the data to the SRC for evaluation in the coming weeks. Importantly, this means we remain on track to report data before the end of the year from our Phase 2a component, and next steps for the Phase 2b cohort before the end of the year.”

Phase 2b will include 10 subjects randomised 8:2 (active: placebo) and will examine if ISLA-101 has activity as a treatment against dengue infection. This is the first time a potential countermeasure to combat the dengue virus, which afflicts more than 400 million individuals a year and for which there is no therapeutic option, is being investigated as both a preventative and therapeutic measure.

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