Island Pharmaceuticals is collecting its first prospective human clinical data on the investigational antiviral galidesivir during the ongoing Bundibugyo Ebola outbreak in Uganda. Deployed under the World Health Organization’s Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework, the drug is being used in a setting where no approved therapies currently exist for that strain. The program allows researchers to evaluate safety, virological activity, and clinical performance in patients with active disease, marking a rare opportunity to generate real-world evidence alongside traditional animal-model studies.
“Under the WHO’s MEURI framework, investigational therapies can be made available when no approved treatment exists, which is particularly important for Bundibugyo Ebola, where there are currently no approved therapeutics,” said David Support, PhD, chief executive officer of Island Pharmaceuticals.
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Island’s primary objectives are to collect clinical, safety, and virological data, and to understand how the drug performs in patients with active disease. The company already has extensive efficacy data from nonhuman primate models. Very few filovirus programs are able to generate both prospective human outbreak data and controlled animal efficacy data in parallel.
A dual strategy for regulatory approval
Island describes its approach as a dual development strategy. The FDA Animal Rule pathway remains the principal regulatory route for diseases where traditional human efficacy trials are not feasible. The agency has already confirmed that the Animal Rule is appropriate for galidesivir’s filovirus program. “At the same time, the MEURI program allows us to collect prospective human efficacy, safety, and virological data during an active outbreak,” Support said. While those data are not intended to replace Animal Rule requirements, they provide real-world evidence from the actual disease setting and can strengthen the overall development package.
Together, the two pathways combine prospective human clinical experience with controlled primate studies, creating what the company believes is one of the strongest development approaches available for a broad-spectrum filovirus countermeasure.
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Broad-spectrum potential against multiple filoviruses
Uganda is currently reporting both Ebola and Marburg virus activity, a situation that highlights the need for treatments that work across strains. Existing Ebola countermeasures are largely strain-specific, and there are no approved therapeutics for Marburg virus disease, Bundibugyo Ebola, or Sudan virus disease. Galidesivir was originally developed as a broad-spectrum direct-acting RNA polymerase inhibitor and has shown activity against Ebola, Marburg, and Sudan virus in preclinical studies.
Collaborative deployment in Uganda
Island’s role is limited to supplying the investigational drug, while government and institutional partners oversee the program. The Uganda Ministry of Health, the ACCEPT-Africa Consortium, the Infectious Diseases Institute, and local ethics committees have built the framework needed to deploy an investigational therapy rapidly during an active outbreak.
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Next milestones and stockpiling prospects
The next major steps for galidesivir remain centered on advancing through the FDA Animal Rule pathway. That includes additional nonhuman primate studies, particularly in Marburg virus models, continued engagement with the agency, and completion of the remaining studies for a registration-quality package. If the MEURI program generates encouraging safety or virological observations, those data could provide supportive evidence.
Just yesterday, Island Pharmaceuticals signed a Statement of Work with Texas Biomedical Research Institute to advance development of galidesivir for Marburg virus disease under the FDA Animal Rule. The collaboration represents the second phase of the company’s dose optimization program, complementing an ongoing study at the US Army Medical Research Institute of Infectious Diseases by evaluating treatment initiation at later stages of infection. The Texas Biomed study is scheduled to begin in early 2027, and together the studies are expected to generate the pharmacokinetic, efficacy, and treatment-timing data needed to complete a planned key Animal Rule efficacy study.