Cambridge, UK: Exvastat Limited, is pleased to announce it has commenced work on a prestigious European Innovation Council (EIC) accelerator grant, to support development of its innovative treatment, Impentri™ (intravenous imatinib) for the treatment of Acute Respiratory Distress Syndrome (ARDS) related to COVID-19.

“The high case-fatality rate associated with the ARDS-like condition of COVID-19 pneumonia emphasises the importance of ARDS and ARDS-like syndromes and the shortage of effective treatments,” said David Cavalla, Chief Executive Officer of Exvastat. “Impentri™ uses a repurposing strategy backed by strong intellectual property and good preclinical and clinical validation of the effect of the drug to reduce pulmonary oedema associated with COVID-19 pneumonia.”

The trial will be conducted at leading clinical trial centres in India to investigate the potential benefit in patients with moderate-severe disease requiring mechanical ventilation associated with COVID-19 infection. The trial is expected to enrol 84 patients. Unlike antiviral approaches, imatinib operates through improving the integrity of the pulmonary endothelium, reducing the pulmonary oedema that is correlated with mortality in all forms of ARDS, and it is therefore anticipated to be a robust mechanism against viral variants and other causes of ARDS.

Imatinib is a well-described drug with a proven safety history that has shown significant promise as a potential treatment for ARDS based on preclinical studies carried out in European and US institutions, as well as multiple clinical case reports of benefit in closely related conditions.

“This important study complements the ongoing clinical investigations of oral and intravenous imatinib for the treatment of COVID-19 pneumonia currently being conducted in the Netherlands. Novel treatments for ARDS and ARDS-like conditions such as COVID-19 pneumonia generally remain a high unmet medical need and an important public health challenge. We would like to thank the EIC accelerator programme for their support of this important study,” said Dr Robert Tansley, Partner at Cambridge Innovation Capital and Exvastat’s Chairperson.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 959310.

About EIC Accelerator programme

The EIC Accelerator remains the largest and most competitive public funding programme in Europe with success rates of less than 3%. Exvastat Ltd is one of 36 companies in receipt of a share of €166m for coronavirus-relevant innovations. The company has been awarded €1.26m to investigate Impentri™, a new intravenous formulation of an existing oral drug therapy, imatinib, in the treatment of the most seriously ill COVID-19 patients.

About Impentri™ (intravenous imatinib)

Imatinib is a well-tolerated treatment for leukemia and certain rare cancers. Following a case report where a patient with a severe ARDS-like condition was administered imatinib off-label, its underlying mechanism in improving the integrity of the pulmonary endothelium via the previously undescribed ARG pathway was revealed by researchers at VUmc, Amersterdam. The efficacy and safety of imatinib has been investigated in the CounterCOVID , Phase 2 clinical study of 386 hospitalised patients with hypoxaemia associated with COVID-19 infection [EudraCT number: 2020-005447-23].

About Exvastat

Exvastat is a clinical stage company developing intravenous imatinib (Impentri™) as a first-in-class pharmacotherapy for COVID-19 pneumonia and all-cause ARDS to lower mortality and improve quality of life of patients. ARDS is a life-threatening respiratory condition with a high mortality and currently lacking any effective, licensed treatment.