Island Pharmaceuticals (ASX:ILA) has announced compelling new preclinical data demonstrating the potential of its broad-spectrum antiviral Galidesivir to combat two of the world’s most lethal viral threats, Marburg and Ebola.
In non-human primate studies, Galidesivir achieved a 94 per cent overall survival rate in Marburg infection, including 100 per cent survival when treatment began within 24 to 48 hours post-infection. In Ebola studies, 100 per cent of subjects survived when Galidesivir was administered immediately or at 48 hours after exposure. Placebo groups recorded 0 per cent survival across both viruses.
These results, supported by robust Phase 1 safety data in humans, will form the basis of Island’s upcoming engagement with the US FDA under the Animal Rule pathway, which enables regulatory approval when human efficacy trials are not feasible. A potential in-person FDA meeting is anticipated next quarter to align on Marburg fast-track approval.
Island CEO and Managing Director, Dr David Foster, said, “These results are exceptional. They provide confidence in Galidesivir’s potential as a critical countermeasure against high-priority viral threats. We are committed to advancing regulatory discussions and positioning Galidesivir as a trusted component of government stockpiles.”
In addition to Marburg and Ebola, Galidesivir has shown antiviral activity against more than 20 RNA viruses, including Yellow Fever, Zika, and MERS, reinforcing its potential as a multi-threat biodefense solution.