Health · Public Health & Disease · 3 hrs ago
Island Pharmaceuticals prepares for Marburg drug study dosing in December
Island Pharmaceuticals is preparing to test its antiviral drug Galidesivir in a study of Marburg virus.
The work is taking place at the US Army’s biodefence research facility in Fort Detrick, Maryland.
USAMRIID has begun procedures for 22 non-human primates assigned to the study; 20 will take part, with two held in reserve.
The study will compare different drug doses and treatment start times against the Angola strain of Marburg virus.
Researchers will measure survival over 28 days, alongside viral levels, clinical signs and drug data.
The results are intended to help choose a dose for a larger, pivotal study.
Dosing is expected to begin in early December, after the animals recover from the procedures.
The work is part of a US Food and Drug Administration pathway for situations where testing a treatment’s effectiveness in people is not ethical or feasible.
USAMRIID has begun surgical preparations for 22 non-human primates ahead of Island Pharmaceuticals’ Galidesivir Marburg dose optimisation study.
The study is expected to begin dosing in early December at USAMRIID’s facility in Fort Detrick, Maryland.
It will assess different Galidesivir doses and treatment start times against the Angola strain of Marburg virus.
The study aims to identify a dosing regimen for a planned pivotal efficacy study under the US FDA Animal Rule pathway.
Survival 28 days after exposure will be the key measure, supported by viral load, clinical observations and pharmacokinetic data.
- Who
- Island Pharmaceuticals and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID).
- What
- USAMRIID has started surgical preparations for a study to optimise Galidesivir dosing against Marburg virus.
- When
- Preparations are underway, with dosing expected to begin in early December.
- Where
- USAMRIID’s facility in Fort Detrick, Maryland.
- Why
- The study aims to identify an effective dosing regimen for Island’s planned pivotal efficacy study.
This story does not have two clearly opposing sides.
Screening and preparation activities for the 22 non-human primates were completed.
USAMRIID started scheduled surgical procedures for the study animals.
Dosing is expected to begin.
- Study animals
- 22 non-human primates, including two reserves
- Study location
- USAMRIID, Fort Detrick, Maryland
- Virus strain
- Angola strain of Marburg virus
- Key measure
- Survival 28 days after exposure
- Planned dosing
- Early December
What people are saying
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.
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.