Island Pharmaceuticals (ASX:ILA) has secured a significant regulatory milestone, with the US Food and Drug Administration (FDA) granting its request for a Type C meeting under the company’s open Investigational New Drug (IND) application for Galidesivir.
The Australian company is developing Galidesivir as a potential treatment for Marburg virus, a rare but deadly disease with pandemic potential. The FDA’s agreement allows Island to align with regulators on using the agency’s 'Animal Rule', a pathway that will enable approval based on well-controlled animal studies when human trials aren’t feasible.
CEO and Managing Director Dr David Foster said the decision marked a pivotal step. “Securing this Type C meeting with the FDA represents an important milestone in advancing Galidesivir towards approval. The guidance from the regulator is expected to provide clarity on the potential to leverage the Animal Rule, as well as important insight into study design requirements and Galidesivir’s eligibility for a Priority Review Voucher,” he said.
Island will submit a comprehensive briefing package, including historical Galidesivir data, before the FDA issues written feedback, which is expected by 12 November 2025. In parallel, the company is preparing to commence an animal study in Marburg in the coming quarter, part of its dual strategy to progress both ISLA-101, being repurposed for dengue and other mosquito-borne diseases, and Galidesivir, which has shown activity against more than 20 RNA viruses, including Ebola, Zika, MERS and Yellow Fever.
“Our goal is to become a trusted provider to government stockpiles, supplying solutions for high-priority public health threats like Marburg,” Foster said.
Island’s progress underscores its ambition to move beyond discovery into a role where it can directly support global health security, particularly as the risks posed by emerging viral outbreaks continue to grow.