Antiviral drug developer Island Pharmaceuticals (ASX: ILA) has been granted an opportunity to advance approval of its lead candidate Galidesivir under the US Food and Drug Administration’s (FDA) Animal Rule.
The FDA confirmed the rule would be an appropriate regulatory pathway for the approval of measures such as Galidesivir developed to counter the deadly Marburg virus.
Written feedback from the FDA responded to a Type-C submission by Island that included a background on Galidesivir’s historical clinical development, its pharmacokinetic and safety data, the results of a non-human primate study, and supporting documentation regarding the use of the Animal Rule for approval.
Life-Threatening Conditions
The FDA’s Animal Rule is used to approve treatments for life-threatening conditions where human efficacy trials are not feasible or ethical, based on data from robust animal models that predict clinical benefit.
Historical data by ++previous owner BioCryst Pharmaceuticals++ has shown Galidesivir to be responsible for a 94% overall survival rate in Marburg-infected subjects compared to 0% survival in a placebo group.
Approval of the rule has enabled Galidesivir to qualify for a tropical disease priority review voucher (PRV), considered one of the most valuable incentives offered by the FDA.
Clinical Development Pathway
Island will incorporate the FDA’s feedback into a clinical development pathway for Galidesivir, and engage with regulatory consultants to assist in advancing approvals in the new year.
The company is working with Biosecurity Level 4 facilities — which provide the highest levels of biological safety — to prepare for the start of an updated animal study.
It is also advancing initiatives for a broader commercialisation strategy positioning Galidesivir as a critical countermeasure against high-priority viral threats for inclusion in government stockpiles.
The US Strategic National Stockpile (SNS) and equivalent programs in allied nations represent a combined annual procurement opportunity of more than US$100 million for countermeasures relating to the Filoviridae family of viruses (which includes Marburg).
De-Risking Galidesivir
Island managing director Dr David Foster said the FDA’s feedback would significantly de-risk the Galidesivir program from a developmental and commercial perspective.
“Confirmation that the Animal Rule is a viable path for development of a Marburg countermeasure and that Galidesivir would qualify for a PRV validates the strength of our existing dataset, highlights the immense opportunity in front of us, and provides a clearly defined, faster path to market,” he said.
“A PRV alone has the potential to generate substantial strategic and financial value for our shareholders, while the Animal Rule pathway enables us to move rapidly towards approval, where traditional trials are not feasible.”
