- The US Food and Drug Administration (FDA) flags amendments and modifications for Island Pharmaceuticals (ILA) phase two clinical trial on dengue fever
- The company submitted an Investigational New Drug application with the FDA on December 28, 2022, to conduct the ISLA-101 phase 2a PEACH clinical trial
- The FDA has provided feedback on this application, specifying amendments to the protocol may be required and the proposed dosing schedule may need to be altered
- Island Pharmaceuticals CEO Dr David Foster says the company will work quickly and constructively to address the Administration’s feedback
- ILA shares last traded at 19 cents at 12:23pm AEDT
Island Pharmaceuticals (ILA) application with the United States Food and Drug Administration for a clinical trial on its dengue fever drug has been placed on Clinical Hold.
The company received FDA feedback today after submitting an Investigational New Drug application on December 28, 2022, to conduct the ISLA-101 phase 2a PEACH clinical trial.
ISLA-101 was originally designed as an anti-cancer and respiratory therapeutics drug, however ILA has repurposed the drug as an anti-viral, particularly focused on dengue fever and other mosquito born diseases.
The phase 2a trial is a randomised, double blind, placebo controlled study for the prophylactic examination of an antiviral in a dengue challenge model.
The FDA has provided feedback on this application, specifying that amendments to the protocol may be required and support for, or modifications of, the proposed dosing schedule may be necessary.
The application has now been placed on Clinical Hold, with a formal hold letter to be
issued by the FDA within the next 30 days.
Island said once it receives the letter, it will work closely with the FDA to resolve the issues, potentially requiring ILA to provide written responses and potentially meeting with the FDA to discuss amendments.
ILA shares last traded at 19 cents at 12:23pm AEDT.