Island Pharmaceuticals Ltd (ASX:ILA, OTC:ILA) has entered into a Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Geneva Foundation to accelerate development of its antiviral drug candidate galidesivir for the treatment of Marburg virus disease.
Investors reacted positively to the announcement, with Island shares rising about 9% as of 12:30 pm AEDT on Thursday, extending gains to roughly 16% over the past week and 50% over the past six months.
The three-party partnership will focus on designing and conducting non-human primate studies required to support potential regulatory approval under the US Food and Drug Administration’s Animal Rule pathway, which allows drugs for serious or life-threatening conditions to be approved based on animal efficacy data when human trials are not feasible.
USAMRIID, the US Army’s premier biodefence research institute and a Biosafety Level-4 facility, has previously played a central role in the development of galidesivir, supporting preclinical and non-human primate studies that demonstrated antiviral activity against both Ebola and Marburg viruses.
Under the agreement, Island will collaborate with USAMRIID and The Geneva Foundation over an initial three-year term, with the option to expand the partnership to further accelerate development of the drug candidate for Marburg virus disease.
“This CRADA is a strategically important milestone and further validates galidesivir’s position within the US biodefence ecosystem,” said Island Pharmaceuticals chief executive officer and managing director Dr David Foster.
“Formal collaboration with USAMRIID — the Department of War’s leading high-containment medical research institute for infectious diseases — and The Geneva Foundation — a leading government program accelerator — significantly strengthens our ability to efficiently execute the final stages of the Animal Rule development pathway.”
Island said the collaboration could help generate the data required to support a future new drug application for galidesivir as a treatment for Marburg virus disease.