Island Pharma has been granted the regulatory approvals needed to allow compassionate use of its antiviral galidesivir in the Bundibugyo Ebola outbreak in Uganda.
The Melbourne, Australia-based biotech said it expects galidesivir to be deployed in the country this year, giving it an opportunity to generate "prospective human efficacy, safety and virological data" during an active outbreak of an Ebola virus species.
Shares in the company on Australia's ASX exchange were trading up nearly 27% at the time of writing.
The announcement comes shortly after two other potential Bundibugyo Ebola treatments - Mapp Biopharmaceutical's MBP134 and Gilead's remdesivir – started human testing in the Democratic Republic of the Congo (DRC), thought to be the epicentre of the current outbreak.
It also comes as the death toll has passed 500, according to WHO figures released yesterday, which also revealed 1,561 confirmed cases in DR Congo since the outbreak was declared in mid-May. There have been two deaths and 20 confirmed cases in neighbouring Uganda.
Island said the approvals "position galidesivir as a potential treatment for Bundibugyo Ebola virus disease, where patients currently have no approved therapeutic options."
The company also said that concurrent Ebola and Marburg activity in Uganda "highlights the growing importance of broad-spectrum antiviral therapies and medical countermeasures, such as galidesivir," and advances the drug across two potential complementary development pathways.
Island is now starting to make clinical supplies of galidesivir available to investigation sites in Uganda for a planned study under the WHO's MEURI framework for accessing experimental therapies during public health emergencies, where no approved treatment options exist and conventional randomised clinical trials cannot be implemented.
Unlike conventional compassionate use programs, MEURI requires prospective collection of clinical, safety and virological data under an approved protocol, enabling investigators to systematically evaluate patient outcomes while providing access to potentially beneficial investigational therapies.
"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," said Dr David Foster, Island's chief executive and managing director.
"This study represents a rare dual-pathway opportunity to advance galidesivir toward potential approval and future government procurement." Pharmaphorum
