Island Pharmaceuticals (ASX:ILA) has expanded its Cooperative Research and Development Agreement with the US Army Medical Research Institute of Infectious Diseases and the Geneva Foundation to fast-track a dose optimisation study of its antiviral candidate Galidesivir for Marburg Virus Disease.
The amended agreement confirms that the planned study will run in USAMRIID’s Biosafety Level 4 facilities and resolves the final study design and resourcing, so the programme can proceed on schedule.
The study will evaluate varying Galidesivir dosing regimens and treatment initiation at either 24 or 48 hours after exposure to the Angola strain of Marburg, with twice-daily intravenous dosing over 14 days and survival assessed to 28 days post-exposure.
The protocol includes a loading dose on day one, comprehensive viral load assessment using RT PCR and plaque assays, haematology, serum chemistry and coagulation analyses, pharmacokinetic sampling and full histopathology to characterise dose-response and translational markers.
Island said it expects dosing to commence next quarter with topline results in the second half of calendar year 2026.
The company said the expanded CRADA materially advances its two-stage Animal Rule development program and strengthens engagement with US biodefence stakeholders.
Prior non-human primate data have shown approximately 94 per cent survival in Galidesivir-treated animals infected with the Marburg Musoke strain compared to zero per cent survival in placebo controls.
CEO and Managing Director Dr David Foster said, “The expansion of our CRADA with USAMRIID and Geneva represents a major strategic milestone for Island and positions the Company to undertake the efficacy study prior to the pivotal study for Galidesivir.”
He added, “USAMRIID is globally recognised as one of the premier biodefence and high-containment infectious disease research organisations in the world. We are grateful for the rare opportunity to establish collaborations of this calibre and advance programs through the FDA Animal Rule pathway within such a highly specialised environment.”
Island said the dose optimisation data will inform the design of a subsequent pivotal confirmatory efficacy study required for potential FDA approval under the Animal Rule and will support future regulatory and procurement discussions.