Island Pharmaceuticals Initiates ISLA-101 Trial For Anti-Drug Activity

Island Pharmaceuticals Ltd, an Australian biotech company specialising in antiviral drug development, has announced the initiation of its Phase 2b clinical trial for ISLA-101. The first participants have already been successfully enrolled. This milestone follows a recommendation from the Safety Review Committee (SRC), which reviewed favourable safety and anti-dengue activity data from the Phase 2a trial. The Phase 2a results were shared in November 2024, and after a 30-day review by the U.S. Food and Drug Administration (FDA), Island Pharmaceuticals has moved forward with the next stage of the study.

The earlier Phase 2a trial explored the preventive potential of ISLA-101 in dengue fever and involved four participants, randomised in a 3:1 ratio (active drug vs. placebo). The ongoing Phase 2b trial is focused on evaluating ISLA-101 as a treatment. This phase will include 10 participants, randomised 8:2 (active drug vs. placebo). The first four participants are already enrolled; the remaining six are expected to join within two weeks.

Island’s CEO and Managing Director, Dr David Foster, said in a statement, “We are excited to start the Phase 2b cohort right on schedule, following the strong data from our Phase 2a cohort and the subsequent recommendation by the SRC to move forward. The SRC’s determination that there was evidence of antiviral activity in ISLA-101-treated subjects in the prophylactic setting was a landmark conclusion. We look forward to seeing if ISLA-101 may also be effective as a treatment in dengue-infected subjects. After an incredibly fruitful 12 months for the ISLA-101 clinical program, we look forward to continuing the momentum and exploring our lead drug candidate as a dengue therapeutic through the Phase 2b study.” 

In the Phase 2b study, participants will be exposed to a weakened strain of the dengue virus and, seven days later, will receive either the investigational drug ISLA-101 or a placebo. The trial's primary goal is to measure reductions in viremia (the amount of virus in the bloodstream). Secondary objectives include confirming the safety profile of ISLA-101 and assessing its impact on dengue symptoms. Top-line results from this therapeutic trial are expected by April 2025.