Positive progress on ISLA-101 clinical program

Island Pharmaceuticals Ltd (ASX: $ILA) has announced positive progress on its ISLA-101 clinical program in dengue fever. The company's ISLA-101 clinical trial protocol amendment has been cleared with the US FDA, and the study is structured as a Phase 2a/b, including a prophylactic and therapeutic arm split across two cohorts. The trial, now renamed PROTECT, has received IRB approval from SUNY Upstate Medical Hospital in Syracuse, NY, enabling the commencement of advertisement to healthy volunteers. With the trial costs substantially reduced, the full Phase 2a/b is expected to cost around US$1.08m.

CEO Commentary on ISLA-101 PROTECT study

Island's CEO and Managing Director, Dr David Foster, expressed, 'We are very pleased to have now locked down our protocol for the ISLA-101 PROTECT study and have it registered, in preparation for final ethics approvals. We have worked hard to bolster our internal capabilities and as a result have not needed to engage a CRO for this study. This strategy not only has streamlined efforts on protocol revisions, FDA communications and trial execution, but has substantially reduced costs enabling us to complete the Phase 2a, prophylactic cohort of the PROTECT study with existing funds.'

Summary of ISLA-101 phase 2a/b clinical trial progress

Island Pharmaceuticals Ltd (ASX: $ILA) has made significant progress with the ISLA-101 clinical program, particularly in the PROTECT Phase 2a/b study for dengue fever treatment. The company's protocol amendments have been cleared by the US FDA, allowing the trial to include a prophylactic and therapeutic arm split across two cohorts. The study has been renamed PROTECT and has received IRB approval from SUNY Upstate Medical Hospital in Syracuse, NY. With trial costs substantially reduced, the full Phase 2a/b is expected to cost around US$1.08m. Island's CEO, Dr David Foster, highlighted the company's internal capabilities and cost reduction efforts, expressing satisfaction with the progress made on the ISLA-101 PROTECT study.