Phase ||| Study update
We are conducting our Phase III REVIVAL pivotal study, a randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center trial to evaluate the efficacy and safety of our proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI. The study will enroll approximately 1400 patients with SA-AKI in the main study population. In two exploratory cohorts, up to 100 patients with moderate Chronic Kidney Disease (CDK) 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. Further information on this study can be found at www.clinicaltrials.gov, NCT04411472 (REVIVAL).
Recombinant Alkaline Phosphatase in COVID-19
Systemic administration of recombinant alkaline phosphatase demonstrated potent inhibition of acute inflammation in kidney, lungs, liver, gut and other organs. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia found in kidney, lung and liver following sepsis or ischemia-induced damage. These potent inhibition processes of acute inflammation and coagulation by dephosphorylating extracellular ATP/ADP are considered to be highly relevant to the respiratory failure and other organ failures described for COVID-19 patients admitted to the ICU.
AM-Pharma included an exploratory cohort to its Phase III REVIVAL pivotal study, to test recombinant alkaline phosphatase in up to 100 COVID-19 patients admitted to the ICU with respiratory issues and AKI to prevent worsening of the disease and to enhance the chance for patients to recover with adequate organ function by including a COVID-19 cohort in its Phase III clinical trial.
Severe COVD-19 patients often present acute inflammation, organ failure with variable rates of Acute Kidney Injury (AKI) and thrombosis; up to 90% of the patients that received mechanical ventilation also suffered from AKI, as reported in the US recently .
Potentially over 100 sites across Europe, the United Kingdom and North America will enroll patients in the study. Topline safety and futility analyses on the first patients is expected by the end of 2021. Target enrollment of up to 1,600 patients and data on the primary endpoint of 28-day all-cause mortality is expected in 2023.
Further information about this study can be found at www.clinicaltrials.gov, NCT04411472 (REVIVAL).
