Antiviral drug development company Island Pharmaceuticals (ASX:ILA) has announced it has completed subject dosing for the Phase 2b treatment arm of the PROTECT clinical trial of ISLA-101 in dengue fever.
The company said the ten subjects in the Phase 2b cohort were successfully administered ISLA-101 on schedule and with no delays.
The Phase 2b arm of the trial is designed to assess if ISLA-101 can reduce virus level and symptoms in a subject already infected with the dengue challenge virus, an attenuated or weakened strain of dengue.
Patient enrollment for the Phase 2b arm commenced in January following a positive assessment by the company's Safety Review Committee on data from its Phase 2a cohort, which determined that key safety and anti-dengue activity benchmarks had been met. The Phase 2a arm examined the preventative arm of ISLA-101 in dengue fever.
The primary endpoint of Phase 2b is 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.
The company said high-level results from the Phase 2b study are anticipated to be available around April.
Island executive chairman Phil Lynch said, “The opportunity for Island is both significant in scale and increasingly positive. The most recent 2a clinical results show the potential for a preventative approach to Dengue management that could aid millions of travellers who visit exposed countries, with malaria treatment a useful analogue to quantify this opportunity.
“We look forward to further positive results from the 2b trial, and thereafter the opportunity to progress ISLA-101 as a potential therapeutic treatment also, for what remains a significant unmet consumer healthcare need.”