Island Pharmaceuticals reports positive anti-viral results from Phase 2a of dengue fever trial
Island Pharmaceuticals (ASX: ILA) has announced that lead candidate ISLA-101 has shown positive safety and antiviral activity in a Phase 2a cohort of its PROTECT Phase 2a/b trial into the treatment of dengue fever.
The trial is assessing whether the drug can prevent or reduce viremia (a medical condition where viruses enter the bloodstream) and symptoms compared to a placebo control.
Island reported in October that that Phase 2a (prophylactic) patients received ISLA-101 before being infected with a weakened strain of the dengue virus developed by the US Army.
SRC findings
The trial’s safety review committee (SRC) reported that blood levels of ISLA-101 were detected in some individuals, confirming that the drug had reached its target concentration.
The results demonstrated that dose-finding work and in silico modelling conducted during and after an ISLA-101 single ascending dose study in June led to the determination of an appropriate therapeutic dose.
The SRC also noted a reduction in viral load in subjects treated with ISLA-101, showing evidence of the drug’s anti-dengue virus activity in the Phase 2a cohort.
It subsequently recommended proceeding with the therapeutic Phase 2b cohort, which will investigate whether ISLA-101 can reduce symptoms in individuals already infected with the dengue virus.
Milestone achievement
Island managing director Dr David Foster said the anti-dengue results were a milestone achievement for the trial.
“Through the past 12 months, we have recorded several important achievements, but this one stands out as the most exciting—and the very reason we started this company,” he said.
“While we are blinded to the full dataset, the unblinded SRC has clearly and unanimously stated there were no safety issues with ISLA-101 and also that the drug showed evidence of anti-dengue virus activity.”
‘Crucial step’
Island scientific advisory board member Stephen Thomas was equally pleased with the results.
“Completing the SRC review process of interim data was a crucial step for the trial and the program and it is promising that the SRC recommended moving to the therapeutic phase of the trial,” he said.
“Finishing the trial will be a big step towards better understanding ISLA-101’s potential to impact dengue disease.”