Australian antiviral drug development company Island Pharmaceuticals (ASX:ILA) has completed the enrolment of all subjects in the Phase 2b therapeutic arm of its ISLA-101 Phase 2a/b PROTECT clinical trial in dengue fever.
ISLA-101 is the company's lead asset. Previous studies have established its safety profile. It is being repurposed for the prevention and treatment of dengue fever and other mosquito-borne diseases.
The company said the Phase 2 study is divided into two cohorts - a Phase 2a (prophylactic) and Phase 2b (therapeutic) cohort.
It has now completed the enrolment of all 10 subjects in the Phase 2b therapeutic arm, following the enrolment of the first four subjects. The final six subjects were enrolled on 21 January.
In Phase 2a prophylactic cohort, the subjects were pretreated with ISLA-101 before exposure to the challenge virus, which is an attenuated or weakened strain of the dengue virus, to explore if ISLA-101 can prevent or reduce infection when administered before exposure to the virus.
In the Phase 2b therapeutic cohort, Island is exploring if ISLA-101 can reduce virus levels and symptoms in an individual who is already infected with the dengue challenge virus.
Between the two studies, Island said it aims to understand if ISLA-101 can be effective as a prophylactic or therapeutic treatment, or both, against dengue infection.
Island progressed to the Phase 2b cohort following the recommendation of the Safety Review Committee (SRC) after it reviewed data from the Phase 2a cohort and determined that ISLA-101 was safe and exhibited antiviral activity. After submitting the SRC recommendation to the US FDA, and allowing for the 30-day FDA-requested review period, Island initiated the Phase 2b cohort in January 2025.