Island Pharmaceuticals has secured all regulatory and ethics approvals to deploy its investigational antiviral Galidesivir under the WHO's MEURI framework during the ongoing Bundibugyo Ebola outbreak in Uganda, creating an opportunity to generate prospective human efficacy and safety data while addressing an urgent unmet medical need.
Island Pharmaceuticals has received all required regulatory and ethics approvals to begin the compassionate use of its investigational antiviral Galidesivir in patients infected during the ongoing Bundibugyo Ebola outbreak in Uganda. The program will operate under the World Health Organization's Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) framework, which enables access to promising investigational therapies during public health emergencies when no approved treatment options exist.
The initiative is expected to generate prospective clinical, safety, and virological data from patients treated during the outbreak while providing access to an investigational therapy for a disease with no approved therapeutics. The government-sponsored program is being conducted in collaboration with the Uganda Ministry of Health, the ACCEPT-Africa Consortium, and the Infectious Diseases Institute at Makerere University. Island's role is limited to supplying Galidesivir, with funding provided through government and institutional partners.
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The approval also advances Galidesivir through 2 complementary development pathways. While the company's primary regulatory strategy remains approval under the FDA's Animal Rule based on non-human primate efficacy studies, the MEURI program provides an opportunity to collect real-world human clinical data during an active outbreak. The company noted that few antiviral development programs have had access to both pathways simultaneously.
"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," Island Pharmaceuticals CEO and Managing Director David Foster, PhD, said in a statement.
The outbreak continues to expand across Uganda and the Democratic Republic of Congo (DRC). As of July 5, the DRC had 1,624 confirmed cases, and 521 confirmed deaths. As of July 7, Uganda has 20 confirmed cases, and 2 confirmed deaths.
Uganda has also confirmed Marburg virus activity, underscoring the need for broad-spectrum antiviral therapies capable of targeting multiple filoviruses. Galidesivir has previously demonstrated activity against Ebola, Marburg, and other filoviruses in preclinical studies.
Look for our Pathogen to Infectious Disease Diagnosis podcast later this week with bioMérieux Chief Medical Officer Chuck Cooper, MD, who discusses the company’s diagnostic platform that can identify this rare strain of Ebola.
