The US Food & Drug Administration confirmed a streamlined development pathway for Galidesivir, an antiviral candidate developed by Island Pharmaceuticals (ASX:ILA).
The decision validates the company's proposed animal model and unlocks the "Animal Rule" approval route, a specialised pathway used when human efficacy trials are unethical or unfeasible.
By aligning on the use of the Angola strain of Marburg virus and the cynomolgus macaque model, the FDA has effectively de-risked the program, providing a clear roadmap toward potential approval and inclusion in the US Strategic National Stockpile.
The newly established two-stage clinical sequence begins with immediate dose-optimisation and pharmacokinetic studies using Island’s first manufactured batch of the drug.
These studies, conducted in collaboration with the high-containment BSL-4 labs at Texas Biomedical Research Institute, will define the optimal treatment window post-infection.
Following successful PK analysis, the program will transition into a pivotal confirmatory phase.
The FDA’s feedback confirms Galidesivir's eligibility for a priority review voucher, a highly coveted asset recently valued at approximately US$200 million.