Island Pharmaceuticals (ASX: ILA) has expanded its Cooperative Research and Development Agreement with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Geneva Foundation to advance its Galidesivir program for Marburg virus disease.
The amended agreement confirms the planned dose optimisation study, resolves final study design and resourcing requirements, and keeps the program on schedule for expected commencement next quarter, with topline results expected in the second half of calendar 2026.
The study will use USAMRIID’s Biosafety Level 4 containment infrastructure and aims to identify the minimally effective Galidesivir dose against the Angola strain of Marburg virus.
USAMRIID is the US Army’s primary research institute for highly hazardous pathogens and the only Department of War laboratory equipped for Biosafety Level 4 containment.
Animal Rule Pathway
The expanded agreement advances Island’s planned two-stage Animal Rule development program and strengthens its engagement with US biodefence stakeholders.
Galidesivir has previously generated non-human primate data showing 94% survival in animals infected with the Marburg Musoke strain and treated with the drug, compared with 0% survival in placebo controls.
The new study will provide dose optimisation, efficacy, and translational data to support progression toward a pivotal confirmatory efficacy study required for potential US Food and Drug Administration approval under the Animal Rule pathway.
Its primary endpoint will assess survival to 28 days after exposure, with additional evaluation of clinical signs, viraemia, clinical pathology, and pharmacokinetic parameters.
The protocol will test a loading dose on day one followed by varying dose regimens and treatment initiation timepoints, with treatment to commence either 24 or 48 hours after Marburg virus challenge and continue through twice-daily intravenous administration over 14 days.
Operational Planning Underway
Island is progressing final operational planning and study preparation with USAMRIID and Geneva ahead of commencement.
The dosing component is expected to run for about 30 days, although high-containment studies require significant preparation and operational lead time.
Subject to successful dose optimisation, Island plans to use the resulting data to design and execute the subsequent pivotal confirmatory efficacy study.
Island is also advancing negotiations with additional Biosafety Level 4 facilities and continuing regulatory, scientific and biodefence engagement, including collaboration with US government stakeholders and evaluation of potential future procurement and stockpiling opportunities.
‘Major Strategic Milestone’
Chief executive officer and managing director Dr David Foster said the expanded agreement represented a significant step for Island.
“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 said
Dr Foster said access to USAMRIID’s specialised infrastructure helped de-risk a critical component of the development pathway.
“Given escalating global concern surrounding Marburg, Ebola, and related filoviruses, we believe Galidesivir remains one of the very few broad-spectrum antiviral candidates globally with demonstrated survival data and the potential to address multiple high-consequence viral threats.
“As we move into this next stage of development, Island is continuing to strengthen its positioning within the global biodefence and medical countermeasure landscape, while advancing toward potential future regulatory approval and government procurement opportunities.”
Broader Antiviral Portfolio
Galidesivir is a clinical-stage antiviral molecule with broad-spectrum activity across more than 20 RNA viruses.
Those targets include high-priority threats such as Ebola, Marburg, Middle East respiratory syndrome, Zika, and yellow fever.
Island is pursuing a dual development strategy across Galidesivir and ISLA-101, which is being repurposed for the prevention and treatment of dengue fever and other mosquito-borne diseases.
Island will host an investor webinar on Friday to outline the expanded CRADA and provide an update on broader biodefence engagement and near-term opportunities linked to Ebola and Sudan virus.