• Galidesivir approved for compassionate use in Bundibugyo Ebola outbreak in Uganda
• Study sponsored by Uganda Ministry of Health and supported by WHO
• Opportunity to generate real-world clinical data in an active outbreak setting
• Dual-pathway strategy for regulatory approval and potential government procurement
• No financial burden on Island Pharmaceuticals as the study is fully funded externally

Island Pharmaceuticals Ltd (ASX: ILA) has secured all necessary regulatory and ethics approvals for the compassionate use of Galidesivir in treating patients infected with the Bundibugyo Ebola virus during the ongoing outbreak in Uganda. The study, conducted under the World Health Organization's Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework, aims to collect clinical, safety, and virological data in real-time. Galidesivir, a broad-spectrum antiviral, has shown efficacy against multiple filoviruses, including Ebola and Marburg, in preclinical and non-human primate studies. The program is fully funded by the Government of Uganda and supporting institutions, with Island's role limited to supplying the drug, making it a non-dilutive opportunity. The study represents a significant milestone for Galidesivir, providing a unique opportunity to evaluate the drug in an active outbreak setting and potentially advance its regulatory pathway.

No specific financial guidance provided in the announcement

The study provides a dual-pathway opportunity for Galidesivir, combining real-world clinical data from the MEURI program with controlled non-human primate efficacy studies under the FDA Animal Rule. This positions Island for potential accelerated regulatory progression and future government procurement.