Island Pharmaceuticals has started surgical preparations on the 22 nonhuman primates that will take part in its Galidesivir dose optimisation study for Marburg virus disease.
The work is underway at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick in Maryland, and the Melbourne antiviral and biodefense company says dosing is still on track to begin in early December.
The surgeries are part of the established study protocol. They follow animal screening and preparation, which Island announced on 19 October. The procedures are designed to allow the animals to be infected with Marburg on Day 0 and to support frequent data collection. Island expects to finish the surgeries over the coming weeks. The animals will then have a scheduled recovery period immediately before dosing starts.
"The commencement of surgical preparations at USAMRIID is another important milestone for Island and demonstrates the continued progress being made towards the start of our Galidesivir dose optimisation study," said chief executive and managing director Dr David Foster.
"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."
The study will test Galidesivir against the Angola strain of Marburg virus. It involves 20 animals, with two more held in reserve, and will compare different dose levels and different treatment start times. The main measure is survival at 28 days after exposure. Viral load, clinical observations and pharmacokinetic data will also be collected.
Dr Foster said the surgeries were routine. "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."
The aim is to find an effective dosing regimen that will shape the design of Island's planned pivotal confirmatory efficacy study. That study is part of the company's development program under the US Food and Drug Administration's Animal Rule. The Animal Rule offers a possible approval route when efficacy studies in humans would be unethical or not feasible.
"With dosing and topline results remaining on track for this quarter, we are approaching a significant stage in the development of Galidesivir," Dr Foster said. "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."
Galidesivir is a clinical-stage antiviral that has shown activity against more than 20 RNA viruses, including Ebola, Marburg, MERS, Zika and yellow fever. Island is developing it alongside a repurposed drug for dengue fever and other mosquito-borne diseases.