Island Pharmaceuticals Ltd. announced that it has received additional feedback following FDA review of the Investigational New Drug (IND) application submitted for its ISLA-101 Phase 2a PEACH 1 clinical trial (ASX announcement: 28 December 2022.) The letter from the US FDA notes that Island's IND had been placed on Clinical Hold, as previously reported. The FDA letter further clarified that amendments to the protocol and IND will be necessary to advance the program. In addition, more data to support the proposed dosing regimen will be required.

Data will be obtained in a small single ascending dose clinical trial that measures blood concentration of ISLA-101, following administration increasing doses of ISLA-101. The aim of this study is to ensure that administered doses can safely achieve blood concentrations of ISLA-101 that are predicted to be effective against the dengue virus. Island is working with vendors and consultants to formulate the most efficient clinical plan and to understand related timing.

The Company anticipates that the trial will be conducted in Australia, which will enable the trial expenses to be off-set by R&D tax credits.