Island Pharmaceuticals Phase 2b clinical trial enrols first subjects
Australian antiviral drug development company, Island Pharmaceuticals (ASX: ILA) has initiated the ISLA-101 Phase 2b clinical trial, with the first subjects successfully enrolled.
Progression to the Phase 2b cohort follows the recommendation of the Safety Review Committee (SRC) after it reviewed positive data from the Phase 2a trial, which demonstrated safety and anti-dengue activity.
Following submission of the SRC recommendation to the US Food and Drug Administration (FDA), and allowing for the 30 day FDA requested review period, Island has now initiated the Phase 2b cohort.
The Phase 2a study examined the prophylactic (preventative) arm of ISLA- 101 in dengue fever, involving four subjects randomised 3:1 (active: placebo). Phase 2b is the therapeutic (treatment) arm of the trial and will involve 10 subjects randomised 8:2 (active: placebo). The first four subjects have already been enrolled, with the second group of six expected to enrol within the next two weeks.
Subjects for this therapeutic cohort will be exposed to an attenuated strain of the dengue virus, then administered either the placebo or ISLA-101 seven days post virus exposure. The primary endpoint of the Phase 2b study is viremia (virus load in the bloodstream) reduction in subjects. Other endpoints include confirming the safety of ISLA-101, and a reduction in the symptoms associated with dengue infection.
High level results from the Phase 2b study are anticipated to be available around April 2025.
