Pivotal Marburg data secured for Galidesivir FDA pathway

• Signed Letter of Authorisation for Marburg-Angola NHP data
• Data integral to FDA Animal Rule pathway
• Avoids recreating equivalent natural history study

Island Pharmaceuticals Ltd (ASX: ILA) has secured a signed Letter of Authorisation (LOA) enabling the use of a detailed Marburg-Angola non-human primate (NHP) natural history study in submissions to the US FDA. This LOA addresses FDA feedback and provides a regulatory foundation for upcoming studies. Island's strategy involves leveraging this data to avoid recreating an equivalent program, saving time and capital. The next steps include a USAMRIID NHP dose optimisation study and a Texas Biomed study to further evaluate Galidesivir's efficacy.

Island Pharmaceuticals plans to advance Galidesivir through pivotal animal studies towards a potential NDA submission and FDA approval.