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- Island Pharmaceuticals (ILA) receives additional FDA feedback after its IND application for a phase two trial of its ISLA-101 drug was put on Clinical Hold
- The letter from the US Food and Drug Administration noted the adjustments needed to the company’s protocol and application to advance the program
- The FDA says more data would also be required to support the proposed dosing regimen
- Island says it plans to obtain this data in a small, single-ascending-dose clinical trial that measures the blood concentration of ISLA-101
- Island Pharmaceuticals shares are trading at 15 cents at 3:37 pm AEDT
Island Pharmaceuticals (ILA) has received additional FDA feedback after its Investigational New Drug (IND) application for a phase two trial of its ISLA-101 drug was put on Clinical Hold.
The FDA placed the application on Clinical Hold in January, and its latest letter noted the adjustments needed to Island’s protocol and application to advance the program.
The FDA said more data would also be required to support the proposed dosing regimen.
Following the feedback, Island said it planned to obtain this data in a small, single-ascending-dose clinical trial that measured the blood concentration of ISLA-101, where it would increase dosages following administration.
The aim of this study is to ensure that administered doses can safely achieve the blood concentrations of ISLA-101 predicted to be effective against the dengue virus.
“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,” Island CEO and Managing Director David Foster said.
“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.”
Island Pharmaceuticals shares were trading at 15 cents at 3:37 pm AEDT.
