Australian antiviral drug development company Island Pharmaceuticals Ltd (ASX:ILA) has announced that ISLA-101 has shown safety and anti-dengue activity in the Phase 2a cohort of the PROTECT Phase 2a/b trial.
The Safety Review Committee (SRC) noted that ISLA-101 blood levels were as expected, with favourable safety and efficacy signals. It recommended that the company proceed with the therapeutic Phase 2b cohort.
Island said the recommendation will be filed with the FDA 30 days before starting the Phase 2b cohort. The planned submission to the FDA would support the start of a study in January 2025.
CEO and managing director Dr David Foster said, “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. While we are blinded to the full dataset, the unblinded Safety Review Committee 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.
“With the support of the recent $3.5m placement, the Phase 2b trial remains fully funded and Island is well positioned to pursue its additional pipeline targets.”
In the Phase 2a trial, subjects received ISLA-101 before being infected with a weakened dengue virus developed by the US Army. Compared to placebo control, the trial assesses whether ISLA-101 can prevent or reduce viremia and symptoms.
Dr Stephen Thomas, the Frank E Young, MD ’56 and Leanne Young Endowed Chair of Microbiology and Immunology at SUNY Upstate and member of the Island Scientific Advisory Board, said, “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. Finishing the trial will be a big step towards better understanding ISLA-101's potential to impact dengue disease.”