Island Pharmaceuticals Ltd (ASX:ILA) has welcomed detailed feedback from the US Food and Drug Administration (FDA) on its Investigational New Drug (IND) submission for the ISLA-101 Phase 2a clinical study.
The US FDA confirmed that Island’s IND had been placed on clinical hold and clarified that the company’s protocol and application needed to be modified to advance the program. In addition, more data is required to support the proposed dosing regimen.
In light of the feedback, Island plans to obtain this data in a small, single-ascending dose clinical trial that measures the blood concentration of ISLA-101, following the administration of 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.
Moving forward, Island is working with vendors and consultants to formulate the most efficient clinical plan for the study.
The company hopes to conduct the trial in Australia, meaning expenses can be offset by R&D tax credits.
Focus on safety
Island 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.”