Island submits key US FDA meeting request for new antiviral asset Galidesivir

• Island submits Type C meeting request with US FDA on new asset Galidesivir
• Biotech seeks alignment on use of FDA animal rule to fast-track Galidesivir for Marburg virus
• Meeting with FDA expected in Q4 CY25 as animal study remains on track to start and complete next quarter

Special Report: Australian antiviral drug development company Island Pharmaceuticals has formally lodged a request for a Type C meeting for Galidesivir with the US Food and Drug Administration (FDA) as part of its open investigational new drug (IND) application.

The request was lodged with the regulator on August 29 (US time), formally initiating communication between Island Pharmaceuticals (ASX:ILA) and the FDA development of Galidesivir for treatment of Marburg virus.

Galidesivir is a clinical-stage antiviral molecule with a broad spectrum of activity in more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever.

Island completed acquisition of the Galidesivir antiviral program from Nasdaq-lited BioCryst Pharmaceuticals in July.

Clarification on use of animal rule

The aim of the meeting is to seek alignment with the regulator regarding the use of the animal rule for Galidesivir’s development and potential approval.

The meeting, requested for Q4 CY25,  will also serve to provide feedback on any other required documentation, study design, quality control and Priority Review Voucher (PRV) potential.

The FDA’s animal rule allows for a drug approval in indications based on animal efficacy data, when human trials are unethical or not feasible, provided safety is shown in humans and the disease is well modelled in animals.

Based on previous clinical development work for Galidesivir – underpinned by more than US$70m in funding support from the US government – Island may have the opportunity to undertake only one additional animal efficacy study, before submission of an IND based on successful results.

Lodgement of the request is in line with Island’s slated timeframe for the ongoing development of Galidesivir.

The biotech is advancing engagement with sites and counterparties for pending studies using Galidesivir in Marburg, which will include an animal study in the next quarter.

Watch: Island Pharmaceuticals CEO David Foster 

‘Opportunity to gain important feedback’

CEO and managing director Dr David Foster said the company was pleased to have kicked off engagement with FDA around its development and approval strategy for Galidesivir.

“This meeting will provide the opportunity to gain important feedback from the regulator and seek alignment on use of the animal rule to accelerate the approval process,” he said.

“Alongside this, we are continuing to work with a number of sites and potential partners to identify an appropriate facility for the planned animal study.

“This work is well progressed and will be a critical step in the development of Galidesivir, ahead of advancing our stated strategy to become a trusted provider to government stockpiles, by supplying solutions for high-priority public health threats like Marburg.”

This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.