Impentri

Development of Impentri, an intravenous imatinib formulation for COVID-19 acute respiratory distress syndrome (ARDS)

Summary

Many people with severe COVID-19 infection experience a build-up of fluid in the lungs, making it hard to breathe and, in the worst cases, contributing to the death of the patient. The body’s own immune response is partly responsible for this build-up of fluid.

There are signs that the generic drug imatinib, which is used to treat certain cancers including some forms of leukaemia, could address the problem. The goal of Impentri is to carry out clinical trials to get solid data on its efficacy and safety as a treatment for COVID-19 patients with a build-up of fluid on the lungs.

The project will run a multi-centre, randomised, double-blind clinical trial involving 100 patients in intensive care. All patients will be monitored for oxygen levels, fluid balance, length of stay and other clinical outcomes.

The project has already received scientific advice from the European Medicines Agency (EMA) for the treatment of acute respiratory distress syndrome. The EMA has also granted orphan drug status.

Achievements & News

Treatment tracker: IMI COVID-19 therapeutics projects make progress

IMI’s COVID-19 therapeutics projects, launched in the wake of the pandemic outbreak, are starting to deliver results.###

The CARE consortium are trying to identify candidates among existing drugs that could be effective as treatments against COVID-19. In the latest project update, it was revealed that the screening of clinically-approved drugs in a SARS-CoV-2 cell-based assay did not provide a promising drug that can quickly be positioned towards clinical development, although some repurposed compounds are still undergoing pre-clinical proof of concept testing. They have identified advanced antibodies, compared to clinical antibodies, and their full profiling is ongoing. The first in vivo testing has started, with the first in human study to start in the second half of 2021.

IMPENTRI is tasked with repurposing and rapidly developing an existing therapy, imatinib, as a new and improved therapeutic approach for acute respiratory distress syndrome (ARDS) caused by infection with SARS-CoV-2. Recruitment for the first clinical trial, a phase 2 trial of orally-administered imatinib in COVID-19 infected and hospitalised patients before they develop ARDS, has been completed. Recruitment for a second trial is set to commence.

MAD-CoV 2 is working on developing COVID-19 antivirals against SARS-CoV-2 by targeting the ACE2 receptor, the virus’s passageway into human cells. Several state-of-the-art advanced platforms for validation of antivirals against SARS-CoV-2 have been developed and some antivirals using this platform have been validated.

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Participants

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Universities, research organisations, public bodies, non-profit groups
  • Academisch Medisch Centrum Bij De Universiteit Van Amsterdam, Amsterdam, Netherlands
  • Stichting Amsterdam Umc, Amsterdam, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Exvastat LTD, Cambridge, United Kingdom
  • K.A.B.S. Laboratories Inc. - Kabs, St-Hubert, Canada
Non EFPIA companies
  • Orion Sante SARL, Le Plesiss Robinson, France

Participants
NameEU funding in €
Academisch Medisch Centrum Bij De Universiteit Van Amsterdam783 193
Exvastat LTD536 601
K.A.B.S. Laboratories Inc. - Kabs438 376
Orion Sante SARL812 914
Stichting Amsterdam Umc1 091 880
Total Cost3 662 964