Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to advise that is has secured all regulatory and ethics approvals to enable the compassionate use treatment of patients infected during the current Bundibugyo Ebola virus outbreak in Uganda using Galidesivir under a Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) protocol.
- All government and regulatory approvals obtained for the compassionate use of Galidesivir as a treatment for infected patients during the ongoing Bundibugyo Ebola epidemic in Uganda
- Island to utilise opportunity to generate human data in an active outbreak setting under the World Health Organization’s (WHO) internationally recognised emergency clinical framework as part of development
- Marks a major opportunity to generate prospective human efficacy, safety and virological data during an active Ebola outbreak – Galidesivir to be deployed within CY26
- Positions Galidesivir as a potential treatment for Bundibugyo Ebola virus disease, where patients currently have no approved therapeutic options
- Bundibugyo Ebola epidemic continues to escalate, with 1,480+ confirmed cases,
- ~450 deaths across multiple densely populated African countries
- Concurrent Ebola and Marburg virus activity in Uganda highlights the growing importance of broad-spectrum antiviral therapies and medical countermeasures such as Galidesivir
- Sponsored by the Uganda Ministry of Health and supported by the World Health Organization (WHO) and leading African infectious disease institutions, validating Galidesivir’s potential as a treatment for Ebola
- Program fully funded by government and supporting institutions, with Island’s contribution limited to the supply of Galidesivir, providing a highly capital-efficient and non-dilutive clinical development opportunity
- Government-sponsored opportunity follows rigorous regulatory and ethics review involving Uganda’s public health, scientific and regulatory authorities
- Clinical opportunity complements demonstrated efficacy in non-human primate (NHP) filovirus models and Island’s FDA Animal Rule approval strategy
- Opportunity advances Galidesivir across two potential complementary development pathways, combining prospective human Ebola clinical data with ongoing pivotal Marburg efficacy studies under the FDA Animal Rule
- Previous NHP studies demonstrated 100% survival in Galidesivir-treated Ebola Zaire-infected primates compared with 0% survival in placebo-treated controls
- Drug deployment to be enabled by recently executed GMP manufacturing campaign, demonstrating readiness to address emerging global viral outbreaks
- Effort further advances Galidesivir towards potential government procurement, biodefence stockpiling and broader commercialisation opportunities as a broad-spectrum antiviral
- Investor webinar to be held on Wednesday, 8 July CY26 at 11:00am AEST
The current Bundibugyo Ebola epidemic continues to accelerate across multiple African countries including the Democratic Republic of Congo and Uganda. As of 6 July 2026, there are 1,481 confirmed cases, 454 deaths and a rising case fatality rate of 31%. Upwards of 70 new cases are being reported daily, leading to a broader spread into multiple new provinces.
Emergency public-health measures have now been implemented in Kinshasa, the most densely populated city in the DRC, the third-most populous city and third-largest metropolitan area in Africa, which has a population of over 15m people. Separately, Uganda, which shares a border with the DRC has also confirmed a Marburg virus fatality, marking a rare dual-pathogen event.
Under the approved program, eligible patients will receive Galidesivir during the current and subsequent outbreaks, with investigators prospectively collecting clinical, safety and virological data in accordance with the World Health Organization (WHO) recognised Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework.
The study has been specifically established to provide compassionate use of investigational therapies during public health emergencies where no approved treatment options exist and conventional randomised clinical trials cannot be ethically implemented.
There are currently no approved therapeutics or vaccines for Bundibugyo Ebola or Marburg virus, creating an urgent unmet medical need and a unique opportunity for Galidesivir to be evaluated in the intended disease setting while providing a new treatment option currently unavailable anywhere for Ebola patients.
The study will be conducted in collaboration with the ACCEPT-Africa Consortium, the Infectious Diseases Institute (IDI) at Makerere University and the Uganda Ministry of Health following receipt of approvals from the relevant Research Ethics Committee, Uganda’s National Drug Authority (NDA) and the Uganda National Council for Science and Technology (UNCST).
The approvals represent the culmination of over 12 months of collaboration between Island and ACCEPT-Africa, which commenced with the objective of establishing clinical capability and outbreak preparedness to evaluate Galidesivir in Africa. Following the emergence of the current Bundibugyo Ebola outbreak, the collaboration transitioned from preparedness planning to implementation of the approved MEURI protocol, enabling rapid deployment of Galidesivir while prospectively collecting valuable clinical data.
Island is now working alongside its established partner network to rapidly supply GMP-grade Galidesivir to participating treatment sites, leveraging the Company’s GMP manufacturing program (refer ASX announcement: 4 June 2026) to support patient treatment under the approved protocol. Island is also operationalising an additional acceleration pathway that may allow Galidesivir to be available for compassionate use prior to the end of CY26.
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