Island Pharma Starts Primate Surgeries for Marburg Study

Island Pharmaceuticals (ASX:ILA) announced that surgical preparations have begun for the non-human primates in its Galidesivir Marburg dose optimisation study at USAMRIID, which the company says keeps dosing on track to start in early December CY26.

The procedures cover the 22 non-human primates (NHPs) allocated to the study at the United States Army Medical Research Institute of Infectious Diseases, Fort Detrick, Maryland. The study will use 20 NHPs, with two held as reserves. Island says the procedures form part of the study protocol and will facilitate Day 0 Marburg infection and frequent data collection. They are expected to be completed over the coming weeks, followed by a recovery period before dosing. The study will test Galidesivir against the Angola strain of Marburg virus at varying dose levels and treatment initiation timepoints, assessing survival at 28 days after exposure alongside viral load, clinical observations and pharmacokinetic data. Island says the results will inform dose selection and the design of a planned pivotal confirmatory efficacy study under the US FDA Animal Rule pathway. Island's CEO says dosing and topline results remain on track for this quarter.

The release does not state when the pivotal confirmatory study would begin or how it would be funded, and it does not report any efficacy data. Dosing has not yet started.