Island Pharmaceuticals (ASX:ILA) secured regulatory and ethics approvals for the compassionate use treatment using its Galidesivir drug candidate for patients infected with the Bundibugyo Ebola virus in Uganda, according to a Tuesday Australian bourse filing.
Eligible patients will receive Galidesivir during the current and subsequent outbreaks. There are currently no approved therapeutics or vaccines for Bundibugyo Ebola or Marburg virus, which are both currently active in Uganda, the filing noted.
Investigators will prospectively collect 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 will be conducted in collaboration with the ACCEPT-Africa Consortium, the Infectious Diseases Institute at Makerere University, and the Uganda Ministry of Health following receipt of approvals from the relevant Research Ethics Committee, Uganda's National Drug Authority, and the Uganda National Council for Science and Technology.