Australian mid-clinical stage antiviral drug development company, Island Pharmaceuticals Ltd (ASX:ILA) has announced that it has received additional feedback following the FDA review of its Investigational New Drug (IND) application for the ISLA-101 Phase 2a PEACH1 clinical trial.
The company said 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," it said.
"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 said it is working with vendors and consultants to formulate the most efficient clinical plan and to understand related timing.
CEO and managing director, Dr David Foster, said, “We appreciate the feedback from the FDA on the trial and understand their primary focus is safety of trial participants, which we agree is of critical importance.
"The feedback in this letter provides very clear feedback on next steps, and we are in the process of working through the plan and associated timelines.
"In view of the vast body of data associated with ISLA-101 we anticipate that the results of the ascending dose trial will be positive, and that we will be able to advance the PEACH Phase 2a clinical trial once this preliminary study has been completed and data analysed. We look forward to keeping the market updated as the study plans and timing are confirmed.”