Island Pharmaceuticals Builds Galidesivir Inventory for Outbreak Response

Island Pharmaceuticals (ASX: ILA) has commissioned a second manufacturing campaign of Galidesivir to expand its available drug inventory for outbreak response, biodefence opportunities, and ongoing regulatory work.

The new production run with PI Health Sciences is expected to lift available supply to about 700 to 800 treatment courses by the fourth quarter of 2026.

Island is building that inventory as the Bundibugyo Ebola outbreak spreads across the Democratic Republic of Congo and associated countries including Uganda, where Galidesivir is expected to be deployed during 2026.

At 18 August, the outbreak had reached 5,208 confirmed cases and 2,476 deaths for a 47.5% case-fatality rate, with its current pace reported at five times that of previous outbreaks at the same stage.

Expanded Outbreak Readiness

The second production campaign will provide Galidesivir manufactured to good manufacturing practice (GMP) standards, expanding supply beyond the quantity previously commissioned with PI Health Sciences.

Island intends the larger GMP-grade inventory to support active outbreak response while giving it greater flexibility to engage with governments, biodefence agencies, and potential procurement partners without waiting for another manufacturing cycle.

The timing follows approval for Galidesivir to be provided on a compassionate-use basis to patients infected with Bundibugyo Ebola virus in Uganda under the World Health Organization-recognised Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework.

“The decision to commission additional GMP Galidesivir reflects the significant progress we’ve made and the increasing breadth of opportunities now available to the program,” chief executive officer Dr David Foster said.

“Combined with our Marburg development program under the US Food and Drug Administration’s Animal Rule, our Ebola activities, and the substantial body of work already completed on Galidesivir, we believe this expanded supply puts Island in a much stronger position to pursue the multiple development and commercial pathways now available to the asset.”

Uganda Human Data

Island expects the Uganda program to create an opportunity to generate prospective human efficacy, safety, and virological data while Galidesivir is deployed during an active outbreak.

The MEURI pathway is particularly relevant because the Bundibugyo strain currently has no approved therapeutic treatment or vaccine, allowing use of an investigational intervention where no approved alternative exists.

Galidesivir has previously delivered 94% survival in a Marburg non-human primate model when treatment began 48 hours after infection, while Ebola studies produced 100% survival at 48 hours and 67% when dosing was delayed to 72 hours.

All untreated animals died in the cited Marburg and Ebola studies, strengthening the development rationale for Galidesivir across multiple filoviruses while Island continues work toward pivotal Marburg studies.

Broader Biodefence Strategy

The expanded supply is intended to support more than the current outbreak, with Island positioning Galidesivir as a broad-spectrum antiviral and biodefence countermeasure for multiple viral threats.

Island says the drug has demonstrated activity across more than 20 ribonucleic acid viruses including Ebola, Marburg, Zika, and yellow fever, giving the program potential relevance beyond a single pathogen.

Its strategy combines potential Animal Rule approval, MEURI-generated human data and a sizeable GMP-grade inventory that can be deployed rapidly if outbreak, stockpiling or government opportunities emerge.

The immediate focus is completion of the second manufacturing campaign, expected in the fourth quarter of 2026, alongside the planned Uganda deployment and continued progression of the Marburg development program.