Island Pharmaceuticals (ASX:ILA) received authorization to cross-reference a detailed non-human primate natural history study of Marburg-Angola virus in submissions to the US Food and Drug Administration (FDA), according to a Monday filing with the Australian bourse.
The letter of authorization follows more than six months of negotiations to secure access to the original natural history study, and addresses an information requirement identified by the US FDA, per the filing.
Island Pharmaceuticals is advancing galidesivir as a potential medical countermeasure for Marburg virus disease under the FDA's animal rule, which provides a pathway for approval in cases where human efficacy trials are unethical or infeasible.
The company said the authorization will provide savings in development time and capital as it will not have to independently recreate an equivalent Marburg natural history program.
Marburg virus disease is an often fatal viral illness that causes bleeding inside and outside the body, according to the World Health Organization's website.
Island Pharmaceuticals shares gained over 2% in recent Monday trade.