Surgical preparations begin for 22 NHPs in Galidesivir Marburg study
Island Pharmaceuticals (ASX: ILA) has advised that scheduled surgical preparations have commenced for the 22 non-human primates (NHPs) allocated to its Galidesivir dose optimisation study targeting Marburg Virus Disease (MVD). The procedures are underway at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, Maryland.
The step follows the completion of NHP screening and preparation activities (refer ASX announcement of 19 October 2026). Dosing remains on track for early December CY26, in accordance with the planned timetable.
Island said dosing remains on track for this quarter, and CEO and Managing Director Dr David Foster said dosing and topline results are both remaining on track for this quarter.
Dr David Foster, CEO and Managing Director
“…these are standard procedures required to support the planned dosing and monitoring activities, and based on the current timeline, everything continues to progress in line with our expected timetable.”
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What the procedures involve and how the study is designed
The procedures form part of the established study protocol. They 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. The NHPs will then undergo a scheduled recovery period immediately prior to dosing.
The study will evaluate Galidesivir against the Angola strain of Marburg virus, with the objective of identifying an effective dosing regimen to inform the design of Island’s planned pivotal efficacy study.
| Study element | Detail |
|---|---|
| Location | USAMRIID, Fort Detrick, Maryland |
| Virus strain | Angola strain of Marburg virus |
| Animals | 20 NHPs, plus 2 reserves (22 total) |
| Variables | Varying dose levels and treatment initiation timepoints |
| Primary measure | Survival at 28 days following Marburg Angola exposure |
| Supporting measures | Viral load, clinical observations and pharmacokinetic data |
Why the dose optimisation study matters under the FDA Animal Rule
The Animal Rule explained
The US Food and Drug Administration (FDA) Animal Rule provides a potential regulatory approval pathway where human efficacy studies are not ethical or feasible.
The results will inform dose selection and the design of Island’s planned pivotal confirmatory efficacy study. The company describes this as a crucial step towards advancing Galidesivir through the FDA Animal Rule approval pathway.
The FDA alignment on the Marburg animal model, secured earlier in 2026, locked in a two-stage development sequence so that parameters from this dose study feed directly into the confirmatory efficacy phase, and it also carries Priority Review Voucher potential.
Galidesivir in context
Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in over 20 RNA viruses, including Ebola, Marburg, MERS, Zika and Yellow fever. Island is executing a dual development strategy for its assets, ISLA-101 and Galidesivir.
Supply for the program comes from GMP manufacturing at PI Health Sciences, where a second 5kg batch targeted for late November is intended to support the pivotal Marburg primate study as well as Island’s wider Ebola strategy.
What happens next for Island
The source sets out the following sequence:
- Surgical preparations are expected to be completed over the coming weeks, followed by a scheduled recovery period.
- Galidesivir dosing is expected to commence in early December CY26, when the USAMRIID study team progresses the NHPs into dosing.
- Dosing and topline results are both remaining on track for this quarter, according to Dr Foster.
- Island will continue to provide updates as material study milestones are achieved.
For investors, the data from the study is expected to play an integral role in informing Island’s pivotal efficacy program and progressing its broader regulatory strategy for Marburg.
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