Island Pharmaceuticals (ASX:ILA) has announced it is advancing GMP manufacturing of its antiviral, Galidesivir, to support a pivotal Marburg study under the US FDA Animal Rule pathway.
The work is being carried out by global CRDMO PI Health Sciences and includes analytical method validation, reference standard preparation, stability studies and scaled manufacture of GMP-grade material intended for late-stage development and regulatory submission.
Manufacturing has already commenced, and Island said it expects to receive GMP-grade product in the coming months.
The material produced through this campaign will be reserved for the planned pivotal efficacy study that is expected to form the cornerstone of a future FDA submission, while existing Galidesivir inventory will be used for dose optimisation studies.
The agreement and GMP supply establish the manufacturing, analytical and quality systems required for future regulatory and procurement activities and create strategic flexibility to respond to biodefence and outbreak opportunities, including the current Bundibugyo Ebola outbreak.
PI Health Sciences operates GMP-compliant facilities across Europe and Asia and provides analytical development and process optimisation services to support clinical development and commercialisation.
Island said that Galidesivir has demonstrated broad-spectrum antiviral activity across more than 20 RNA viruses, including Ebola and Marburg, and that establishing a clinical-grade supply is an increasingly important strategic asset as biodefence preparedness gains global attention.
CEO and Managing Director Dr David Foster said, "The commencement of GMP manufacturing is a significant milestone and represents another important step in the commercialisation pathway for Galidesivir."
He continued, "Importantly, Island already has sufficient Galidesivir supply to support our planned dose optimisation studies. The material being manufactured under this agreement is intended for the pivotal efficacy study that is expected to form the cornerstone of a future FDA submission under the Animal Rule pathway."
Dr Foster added, "As we advance our clinical trial pathway for Marburg, we are becoming increasingly focused on concurrently assembling the manufacturing, quality and regulatory framework required to support potential approval and procurement." With manufacturing underway and non-human primate access close to finalised, the company says it is systematically building the elements required to position Galidesivir as a potential countermeasure for Marburg Virus Disease and other high-consequence viral threats."