The first patients with COVID-19 infection and sepsis-associated acute kidney injury (SA-AKI) have been enrolled in AM-Pharma’s Phase III REVIVAL pivotal trial in an exploratory cohort to assess the safety, tolerability and clinical benefit of recombinant alkaline phosphatase.
Patients with severe COVID-19 infection often present with acute severe inflammation and organ failure. Recent studies conducted in the US demonstrated that up to 90% of the COVID-19 patients that received mechanical ventilation also suffered from AKI and that the development of AKI in these patients is associated with poor prognosis.
AM-Pharma, a Dutch company focused on the treatment of kidney disease, sepsis and organ injury, received an innovation credit of up to EUR 5 million from the Netherlands Enterprise Agency (RVO.nl), which has been established by the Dutch Ministry of Economic Affairs and Climate Policy to support the development of innovative programs with promising market potential.
Erik van den Berg, CEO of AM-Pharma, said: “The prevalence of COVID-19 infections and the high AKI comorbidity support our decision to include this additional cohort into our Phase III REVIVAL pivotal study.
“By providing our proprietary recombinant alkaline phosphatase to clinicians for evaluation in severe COVID-19 cases, we aim to make our novel treatment option available for these patients.”
The REVIVAL Phase III pivotal trial is a randomised, double-blind, placebo-controlled, two-arm, parallel-group, multi-centre trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI.
The study will enrol approximately 1400 patients with SA-AKI in the main study population. In two exploratory cohorts, up to 100 patients with moderate Chronic Kidney Disease (CKD) and up to 100 patients with COVID-19 will be enrolled.
The primary aim of the study is to confirm the improvement on the primary endpoint of 28-day all-cause mortality, as observed in the Phase II STOP-AKI study.
Secondary endpoints include the treatment effect on long-term Major Adverse Kidney Events (MAKE), on the use of organ support, length of stay in the ICU and on 90-day all-cause mortality.