AM-Pharma has announced the enrolment of first participants in an exploratory cohort in Phase III REVIVAL pivotal trial of its human recombinant alkaline phosphatase (AP) for treating patients with Covid-19 and sepsis-associated acute kidney injury (SA-AKI).
The therapeutic candidate derives from two naturally occurring human isoforms of the AP enzyme.
For the Covid-19 cohort clinical study, Dutch Ministry of Economic Affairs and Climate Policy-established Netherlands Enterprise Agency (RVO) extended an innovation credit of up to €5m to AM-Pharma.
The randomised, double-blind, placebo-controlled, two-arm, parallel-group, multi-centre trial will analyse the efficacy and safety of the compound for treating patients with SA-AKI.
The main study population will include around 1400 patients with SA-AKI. Up to 100 patients with moderate chronic kidney disease (CKD) and up to 100 patients with Covid-19 will be enrolled in two exploratory groups.
Proving the improvement in the primary endpoint of 28-day all-cause mortality, as seen in the Phase II STOP-AKI study, will form the study’s primary endpoint.
Effect of the therapy on long-term Major Adverse Kidney Events (MAKE), on the use of organ support, ICU stay length and on 90-day all-cause mortality are some of the secondary endpoints.
AM-Pharma noted that severe Covid-19 patients often have acute severe inflammation and organ failure.
According to latest studies carried out in the US, up to 90% of the Covid-19 patients who received mechanical ventilation also had AKI and its development is linked to poor prognosis.
AM-Pharma CEO Erik van den Berg 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.”
In July 2019, AM-Pharma raised €116m from a European syndicate of new and existing investors to support the initiation of a Phase III trial of its recombinant human alkaline phosphatase (recAP) therapeutic for patients with SA-AKI.