Island Pharmaceuticals (ASX:ILA) has disclosed that scheduled surgical preparations have commenced for 22 non-human primates (NHPs) at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, Maryland, ahead of a Galidesivir dose optimisation study targeting Marburg Virus Disease, with dosing expected to begin in early December 2026.

Key Points

  • USAMRIID has commenced surgical preparations for 22 NHPs allocated to the Galidesivir Marburg dose optimisation study
  • Procedures are designed to facilitate Day 0 Marburg infection and support frequent collection of study data
  • Galidesivir dosing remains on track to commence in early December 2026 following surgery and recovery
  • The study will involve 20 NHPs with two additional animals available as reserves, assessing varying dose levels and treatment initiation timepoints
  • Data generated will support Island's development program under the US FDA Animal Rule pathway

Surgical Preparation Details at USAMRIID

According to the filing, surgical preparations for the 22 NHPs have commenced at USAMRIID, Fort Detrick, Maryland, USA. The procedures form part of the established study protocol and are designed to facilitate Day 0 Marburg infection and support the frequent collection of study data. Surgical preparations are expected to be completed over the coming weeks, after which the NHPs will undergo a scheduled recovery period immediately prior to dosing. The commencement of these procedures follows the previously completed NHP screening and preparation activities.

Galidesivir Marburg Study Design and Objectives

The USAMRIID study will evaluate Galidesivir against the Angola strain of Marburg virus. The study will involve 20 NHPs, with two additional animals available as reserves, and will assess Galidesivir administered at varying dose levels and treatment initiation timepoints. The study will assess survival at 28 days following Marburg Angola exposure, supported by additional measures including viral load, clinical observations, and pharmacokinetic data. The objective is to identify an effective dosing regimen to inform the design of Island's planned pivotal confirmatory efficacy study.

FDA Animal Rule Pathway and Next Steps

Data generated from the USAMRIID study will support the company's ongoing development program under the US Food and Drug Administration's Animal Rule pathway, which provides a potential regulatory approval pathway where human efficacy studies are not ethical or feasible. Following completion of surgical procedures and the recovery period, the USAMRIID study team will progress the NHPs into commencement of Galidesivir dosing during early December 2026. The results will inform dose selection and the design of Island's planned pivotal confirmatory efficacy study. The company said it will continue to provide updates as material study milestones are achieved.