ISLA-101 PROTECT Trial Reaches Key Milestone, Pioneering Hope For Viral Respiratory Infections

Island Pharmaceuticals Ltd (ASX: ILA), an Australian company developing antiviral drugs, has shared an update on the progress of its ISLA-101 Phase 2a/b clinical trial for dengue fever. In the Phase 2a trial, participants were given ISLA-101 before being exposed to a weakened form of the dengue virus developed by the US Army. The study is designed to see if ISLA-101 can lower the viral load in the blood (viremia) or reduce symptoms compared to those who receive a placebo. Earlier research has revealed that untreated participants typically experience higher viremia and more severe symptoms.  

Since announcing on October 3, 2024, that all Phase 2a participants had been dosed, Island has completed sample collection to analyze changes in viremia levels. The samples are also being tested for drug absorption (pharmacokinetics) and other blood markers. The data is now being reviewed by the Safety Review Committee (SRC), which will assess the safety of ISLA-101 and its potential effectiveness against dengue. The SRC's recommendations about moving to the Phase 2b stage of the trial are expected before the end of the year.

Island’s CEO and Managing Director, Dr David Foster, said in a statement, “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.”

The Phase 2b trial will involve 10 participants, randomly assigned in an 8:2 ratio (active treatment to placebo), to assess whether ISLA-101 can effectively treat dengue infection. This marks the first time that a potential treatment targeting the dengue virus—affecting over 400 million people annually and currently without a therapeutic option—is being explored for both prevention and treatment.