AM-Pharma has recruited first patients with Covid-19 infection and sepsis-associated acute kidney injury (SA-AKI) in an exploratory cohort of its phase III REVIVAL pivotal trial.
The phase III randomised, double-blind, placebo-controlled, two-arm, parallel-group and multi-centre study will assess safety, tolerability and clinical benefit of the company’s human recombinant alkaline phosphatase to treat patients with SA-AKI.
AM-Pharma will recruit up to 1,400 patients with SA-AKI in the main study population. The company will recruit up to 100 patients with moderate chronic kidney disease (CKD) and up to 100 patients with Covid-19 in two exploratory cohorts.
AM-Pharma stated that the study is aimed to confirm the improvement on the primary endpoint of 28-day all-cause mortality, as noticed in the phase II STOP-AKI study.
The trial’s secondary endpoints consist of 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.
The company is recruiting patients with SA-AKI in more than 100 sites across Europe and North America in the phase III REVIVAL trial.
AM-Pharma secured an innovation credit of up to €5m from the Netherlands Enterprise Agency, which was established by the Dutch Ministry of Economic Affairs and Climate Policy to support the development of innovative programmes.
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 December 2020, FSD Pharma dosed the first patients in its phase 2a clinical trial designed to assess FSD201 (ultramicronised palmitoylethanolamide or ultramicronised PEA) for the treatment of hospitalised patients with Covid-19.