Island Pharmaceuticals advances Marburg study towards December dosing

• USAMRIID starts surgical preparations for 22 non-human primates ahead of Island’s Galidesivir Marburg dose optimisation study
• Procedures part of established protocol and will facilitate targeted drug delivery and monitoring during study expected to start in December
• Study designed to identify optimal Galidesivir dosing regimen for planned pivotal confirmatory efficacy trial under US FDA Animal Rule pathway

Special Report: Island Pharmaceuticals has reached another milestone in the development of its antiviral drug Galidesivir, with surgical preparations underway for a Marburg virus dose optimisation study at a US biodefence research facility.

The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) has started scheduled surgical procedures for 22 non-human primates (NHPs) allocated to the study at its facility in Fort Detrick, Maryland.

Island Pharmaceuticals’ (ASX:ILA) said the preparations followed successful completion of NHP screening and preparation activities in October and marked another step towards the start of dosing.

The procedures form part of the established study protocol, supporting Marburg virus infection on Day 0 and the frequent collection of study data.

Surgical preparations are expected to be completed over the coming weeks followed by a recovery period ahead of dosing, which remains on track for early December.

Study to identify optimal Galidesivir dosing

The study will evaluate Galidesivir against the Angola strain of Marburg virus, with the aim of identifying an effective dosing regimen to inform ILA’s planned pivotal efficacy study.

It will involve 20 NHPs, with two additional animals available as reserves, and assess Galidesivir at varying dose levels and treatment initiation timepoints.

Survival at 28 days following Marburg Angola exposure will be the key measure, supported by viral load, clinical observations and pharmacokinetic data.

The findings will support ILA’s development program under the US Food and Drug Administration’s (FDA) Animal Rule pathway, which provides a potential route to regulatory approval when human efficacy studies are not ethical or feasible.

CEO Dr David Foster said the start of surgical preparations was key progress for the antiviral drug development and biodefence company, demonstrating the continued progress being made towards its Galidesivir dose optimisation study.

“Following the successful screening and preparation of all 22 NHPs earlier this month, we are pleased to see the program advance into this next phase, the final step before the study begins,” he said.

“Importantly, these are standard procedures required to support the planned dosing and monitoring activities, and based on the current timeline, everything continues to progress in line with our expected timetable.

“With dosing and topline results remaining on track for this quarter, we are approaching a significant stage in the development of Galidesivir.

“The data generated from this study will play an integral role in informing our pivotal efficacy program and progressing our broader regulatory strategy for Marburg,” he added.

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.

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