Periodic Reporting for period 2 - Impentri (First effective pharmacotherapy for ARDS to lower mortality and improve quality of life of patients.)
Reporting period: 2021-10-01 to 2022-09-30
The overall objective of this project was to establish a clinical trial in India, to evaluate intravenous imatinib (Impentri®) for the treatment of critically ill patients with COVID-19 induced Acute Respiratory Distress Syndrome (ARDS). Based on the results of these studies, additional investment would be sought to enable further development.
ARDS is a condition which interferes with the lung’s ability to absorb oxygen and in COVID-19 was the immediate cause of death for patients suffering from this infection. The substantial mortality, morbidity, and economic burden of ARDS, along with the absence of available therapy, mean this project has the potential to make a significant impact on society.
Despite successfully initiating the clinical trial and considerable efforts to amend the protocol to include a wider range of patients, it has not been possible to recruit patients into the trial and a decision to terminate early was made.
ARDS is a condition which interferes with the lung’s ability to absorb oxygen and in COVID-19 was the immediate cause of death for patients suffering from this infection. The substantial mortality, morbidity, and economic burden of ARDS, along with the absence of available therapy, mean this project has the potential to make a significant impact on society.
Despite successfully initiating the clinical trial and considerable efforts to amend the protocol to include a wider range of patients, it has not been possible to recruit patients into the trial and a decision to terminate early was made.
A suitably stable formulation of Impentri® in a sterile vehicle had been developed, and further quantities were manufactured for the trial. Vials of Impentri and placebo were shipped, in readiness for the start of the clinical trial, representing the culmination of a 9-month campaign of work.
Efforts then focussed on preparing all necessary regulatory documentation required to initiate the clinical trial. In parallel, 5 clinical sites were recruited across India, with a further 5 back-up sites identified. Regulatory and ethical approvals from the Indian authorities was secured in Aug 2021 and the trial initiated the following month.
Unfortunately, in the Autumn of 2021, COVID-19 infections in India dropped significantly and there were negligible patients requiring hospital ICU treatment. Recognising this significant reduction in patient numbers, the team submitted an amended protocol to the Indian regulators, requesting the additional inclusion of patients with non-COVID 19 pneumonia in the trial, but this was declined. With no expectation of further COVID-19 patients, the trial was terminated.
As the clinical trial was terminated early, there are no project results that can be exploited.
Efforts then focussed on preparing all necessary regulatory documentation required to initiate the clinical trial. In parallel, 5 clinical sites were recruited across India, with a further 5 back-up sites identified. Regulatory and ethical approvals from the Indian authorities was secured in Aug 2021 and the trial initiated the following month.
Unfortunately, in the Autumn of 2021, COVID-19 infections in India dropped significantly and there were negligible patients requiring hospital ICU treatment. Recognising this significant reduction in patient numbers, the team submitted an amended protocol to the Indian regulators, requesting the additional inclusion of patients with non-COVID 19 pneumonia in the trial, but this was declined. With no expectation of further COVID-19 patients, the trial was terminated.
As the clinical trial was terminated early, there are no project results that can be exploited.
Results from a clinical study of oral imatinib for the treatment of patients with severe COVID-19 published in June 2021 demonstrated that it reduces mortality by 49% in hospitalized patients and reduces duration of mechanical ventilation and days in the ICU.
Confirmation of these effects in this EIC funded clinical study, might have provided further evidence to support the development of Impentri® for the treatment of patients with COVID-19 ARDS and ARDS from other causes.
With the decline in medical need and difficulty of recruitment in COVID-19, the company are now focussing on related indications to generate both preclinical and Phase II clinical data to support licensing and funding of progression to Phase III.
Confirmation of these effects in this EIC funded clinical study, might have provided further evidence to support the development of Impentri® for the treatment of patients with COVID-19 ARDS and ARDS from other causes.
With the decline in medical need and difficulty of recruitment in COVID-19, the company are now focussing on related indications to generate both preclinical and Phase II clinical data to support licensing and funding of progression to Phase III.