About

Objectives

The Impentri IMI2 project involves the repurposing and rapid development of an existing therapy, imatinib, as a new and improved therapeutic approach for acute respiratory distress syndrome (ARDS) resulting from SARS-CoV-2 infection. More details about the technology can be found here

The accumulation of fluid in the lungs is a significant feature of the pathology in patients with severe Covid-19 infection and contributes to difficulty in breathing and in some cases death. The project aims to target the root cause of the condition, decrease mortality and improve the quality of life of the patient.

This clinical stage project aims to investigate the use of imatinib in two pilot clinical studies for the treatment of Covid-19 ARDS. The first trial, a Phase II trial of orally administered imatinib in COVID-19 infected and hospitalised patients before they develop ARDS has already begun (EUDRACT no. 2020-001236-10). The second trial will be a randomized, double-blind, Phase II study to evaluate the efficacy, safety and pharmacokinetics of intravenously administered imatinib (Impentri®) in patients with Covid-19 associated ARDS.

Following demonstration of safety and efficacy in Covid-19 ARDS, Impentri will be made available for compassionate use, and it is hoped, will be progressed to Phase III studies and subsequent regulatory approval and commercialization.

 

The Consortium

The teams in the Netherlands at VU and AMC in Amsterdam, will lead the Phase II clinical research program in Covid-19 patients at risk of ARDS using oral imatinib, and then in ICU patients with ARDS using IV imatinib (Impentri). Development and supply of the IV formulation of imatinib will be conducted by KABS Pharmaceutical Services in Canada, with clinical operational support from Simbec-Orion, based in France. The overall project coordination will be managed by Exvastat Ltd.