Uganda approves Galidesivir for compassionate use amid Bundibugyo Ebola outbreak

Island Pharmaceuticals (ASX:ILA) has secured all regulatory and ethics approvals to allow the compassionate use of galidesivir for patients infected during the escalating Bundibugyo Ebola outbreak in Uganda under a Monitored Emergency Use of Unregistered and Investigational Interventions protocol.

The approvals, granted after review by Uganda’s Research Ethics Committee, National Drug Authority and National Council for Science and Technology, will let clinicians prospectively collect clinical, safety and virological data in line with the World Health Organization’s recognized MEURI framework.

As of 6 July 2026, the outbreak had reached 1,481 confirmed cases and 454 deaths and was spreading to new provinces, with more than 70 new cases reported daily. Emergency public health measures have been implemented in Kinshasa, a city of over 15 million people, and Uganda has also confirmed at least one Marburg virus fatality, creating a rare dual pathogen scenario. With no approved therapeutics or vaccines for Bundibugyo Ebola or Marburg virus, the MEURI program provides an urgently needed pathway for access to investigational therapies while generating real-world evidence.

The MEURI framework requires prospective data collection under an approved protocol and was developed after the 2014 West African Ebola outbreak to provide structured access to promising investigational treatments during public health emergencies when conventional randomised trials are not feasible.

Under the approved program, eligible patients will receive GMP-grade galidesivir at participating treatment sites, and Island will supply the drug while the program is sponsored and fully funded by the Government of Uganda and supporting institutions, making the effort non-dilutive for Island shareholders.

Island described this as the first opportunity for galidesivir to be prospectively evaluated in patients during an active Ebola outbreak and as a complement to ongoing controlled non-human primate efficacy studies being pursued under the US FDA Animal Rule.

The company said that very few antiviral programs have both a real-world clinical pathway and an Animal Rule pathway open simultaneously, and that data from MEURI could support regulatory submissions alongside preclinical evidence.

Chief Executive Officer and Managing Director Dr David Foster said, “Securing all regulatory and ethics approvals to commence this effort represents a significant milestone for galidesivir and the culmination of more than a year of collaboration with our partners in Uganda and the ACCEPT Africa Consortium. The decision to approve this program reflects a rigorous scientific and ethical review process involving Uganda’s leading regulatory and public health authorities and provides an important validation of galidesivir’s existing body of preclinical and clinical evidence.

“The current Bundibugyo Ebola outbreak highlights the urgent need for new antiviral treatment options. With no approved therapeutics for Bundibugyo Ebola or Marburg virus, and with the outbreak accelerating across multiple provinces, the WHO’s MEURI study framework provides the first opportunity to evaluate Galidesivir in real-world infected patients while prospectively collecting clinical, safety and virological data. Together with our ongoing FDA Animal Rule program and previously generated efficacy data in non-human primate filovirus models, this study represents a rare dual pathway opportunity to advance Galidesivir toward potential approval and future government procurement.”