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Got it!Impentri™ is a stable intravenous formulation of imatinib, an oral tyrosine kinase inhibitor used for the treatment of chronic myelogenous leukaemia and other rare cancers.
Background
In 2008 a woman with life-threatening pulmonary oedema was treated in an Amsterdam hospital. She was resistant to all the normal therapeutic options and treated off-label with imatinib - a drug then thought promising for pulmonary hypertension. The oedema disappeared within 24 hours, leading to the hypothesis that the same drug could be effective in similar conditions, like Acute Respiratory Distress Syndrome (ARDS). This has now been confirmed in a Phase II proof-of-concept study.
Following this work, the potential application of this discovery in other conditions involving pulmonary oedema was considered. A patent was filed and granted on the use of imatinib in such conditions. A series of in vitro and in vivo experiments established the mechanistic basis of imatinib’s effect - via a different enzyme than that responsible for its oncolytic effect. Functionally, it has a direct effect on pulmonary endothelial barrier dysfunction, the final common pathway in ARDS, regardless of the primary cause.
Other laboratories confirmed the preclinical results. Other case reports validated the findings in other medical conditions involving pulmonary oedema, including COVID-19.
About Impentri™
Impentri™ is a high impact product that is uniformly effective in a heterogeneous condition. The new treatment is based on the drug's ability to inhibit vascular leak, which drives the pulmonary oedema. It has proven effective in a number of human case reports as well as in vivo models.
ARDS currently lacks any approved pharmaceutical therapy, with treatment limited to supportive ventilatory care. As Impentri™ can significantly reduce the high mortality and incapacitating morbidities caused by ARDS, it will radically reduce the cost of care.
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perfect for critical care
without delay
mechanical ventilation
GI tract absorption
Clinical Development
Impentri™ is currently being advanced through human trials
Initially we evaluated the safety of imatinib in conditions similar to ARDS, involving a challenge test to human volunteers. Full details are available on the Clinicaltrials.gov website. The second, Phase II trial was then conducted at sites across the Netherlands, to assess the effect of oral imatinib on patients with severe COVID-19 infection (CounterCOVID). Full protocol details are available on the EU Clinical trials register. The trial recently completed and the results published in the Lancet Respiratory Medicine, showing a substantial benefit on mortality in these patients.
A third, Phase II trial has commenced, to investigate IV imatinib (Impentri™) for the treatment of critically ill patients with COVID induced ARDS. This trial is being funded by the Innovative Medicines Initiative (IMI), and more details can be found at the Impentri website.
A fourth Phase II trial commenced in Q4 2021 at hospitals across India to investigate the potential benefit of IV imatinib (Impentri™) for the treatment of critically ill patients with moderate-severe COVID-19 induced ARDS. This trial was funded by the Horizon 2020 research and innovation programme and European Innovation Council (EIC) under grant agreement No 959310. Unfortunately, this study was withdrawn in the summer of 2022, due to the lack of patients meeting the requirements for the study. More details can be found on ClinTrials.gov.