Island Pharmaceuticals Ltd (ASX:ILA) has passed the final key milestone before beginning a Single Ascending Dose study for ISLA-101 with Human Research Ethics Committee (HREC) approval received.
The antiviral drug development company is repurposing ISLA-101, a well-known drug candidate, for the prevention and treatment of dengue and other mosquito (or vector) borne diseases.
ILA’s Single Ascending Dose study is a dose escalation study, in which three cohorts of healthy subjects will receive escalating doses of ISLA-101.
Island Pharmaceuticals CEO Dr David Foster said, “Ethics approval was the final step in being able to commence our Single Ascending Dose study for ISLA-101 and we now look forward to recruiting and dosing our first subject shortly."
Aim of study
The aim of the study is to ensure that administered doses could safely achieve blood concentrations of ISLA-101 that are predicted to be effective against the dengue virus.
Recruitment, patient screening and dosing will begin imminently, with the final data readout expected in early 2024.
The study will be run at Scientia Clinical Research’s clinical trial facilities in Sydney Australia, by Beyond Drug Development as Contract Research Organisation.
Urgent need for treatment
"If all runs smoothly, our aim is to have final data by early 2024 and then rapidly transition to the Phase 2 PEACH study soon thereafter,” Foster said.
“The need for dengue fever preventative and treatment options is more urgent than ever, with the disease now endemic in more than 100 countries, including record cases in Europe and recent major outbreaks in countries such as Peru, Jamaica and Bangladesh."
Insights gained from this study will pave the way for optimising protocols for Island’s planned Phase 2a PEACH clinical trial.