IMPENTRI IMI2 CONSORTIUM
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 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.
In accordance with policies on the sharing of digital research data arising from projects funded by IMI, the IMPENTRI project will make available all appropriate data within 30 days of its creation.
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|5.13||Data Management and validation plan||Sept 2020|
|1.11||First Study Subject Approvals Package, oral study||Details||Aug 2020|
|7.1||A Face to Face consortium kick-off meeting||The project kick-off meeting occurred on 13th July 2020. Due to the COVID pandemic, this took place by videoconference||Jul 2020|
|7.2||An infrastructure for secure communication between consortium members||A sharepoint collaboration site has been established and it's use endorsed by the General Assembly||Jul 2020|
|7.3||A consortium brand to be used consistently in al internal and external communications||A project logo has been designed and utilised internally and externally on communication material||Aug 2020|
|7.4||Website and social media presence||https://impentri.exvastat.com||Aug 2020|
|8.1||Ethics approval for COUNTER COVID study||The CMMO in the Netherlands approved the study protocol and patient consent letter, prior to the study start. FURTHER INFORMATION||Oct 2020|
|1.10||COUNTER-COVID midterm recruitment report||The DSMB conducted a safety assessment at their 3rd meeting on 22 Oct, based on data for 115 patients who had completed 28 day follow-up. They recommended that the study be continued. 50% recruitment to the study (193 patients) was achieved on 29th October.||Jan 2021|
|3.1||Methods for specification in place||Analytical methodology for the drug product formulation testing (for both release and|
stability studies) are in place. The drug product specification is in place prior to regulatory
|3.2||Laboratory Batch||A Laboratory Batch (Engineering / Stability Batch) has been manufactured and tested to the Drug Product Release Specification||Nov 2020|
|3.3||Product Contact Part Compatibility report||The compatibility of imatinib drug product solution with product contact parts has|
been tested and confirmed acceptable. No evidence of adsorption or degradation was
|3.4||Technology Transfer Document||Prior to commencing manufacture of Clinical Trial supplies, there has been a review of all|
supporting documentation and justifications. This “readiness to manufacture” assessment
has been collated as a Technology Transfer Document
|3.5||Filter Validation report||Bubble point testing was performed during the manufacturing|
process and documented within the Executed Master Batch Records to confirm that sterilisation by filtration had been achieved
|3.6||Sterilisation report||Media Fill Certificate - COC2088 confirms that the KABS facility is appropriate for aseptic|
fill and sterile filtration
|3.8||CMC section of IMPD||A full Drug Product section (Module 3) of the IMPD has been prepared and has been submitted as part of the CTA to the relevant regulatory authority for review and approval||Jan 2021|
|3.10||One month solution stability||One month stability data for the Laboratory Batch have been submitted as part of the IMPD||Jan 2021|
|5.1||Protocol of Phase II IV study||The protocol will be available to view once approved at https://www.clinicaltrialsregister.eu||Dec 2020|
|5.2||Investigator Brochure (IB)||The IB has been completed and will be submitted to regulatory authorities for review||Nov 2020|
|5.3||Investigational Medicinal product Dossier (IMPD)||The IMPD has been completed and will be submitted to regulatory authorities as part of the CTA||Dec 2020|
|5.4||Clinical Trial Application (CTA)||The CTA has been submitted for review. Once approved information contained will be available at https://www.clinicaltrialsregister.eu/||Dec 2020|
|5.6||Ethics Submission of Phase II IV study||The CTA was submitted in Dec 2020. Confirmation of ethics approval will be made available on https://www.clinicaltrialsregister.eu/||Dec 2020|
|5.8||Site Audit reports||A Research Statement/Certificate of suitability for the Research Institution (VGO) has been completed for the sites at AMC and OLVG confirming that the sites are suitable to conduct the research.||Jan 2021|
|5.12||DSMB Charter||The DSMB charter was included as part of the CTA submitted in Dec 2020.||Jan 2021|