Data from Pharmawand - Curated by EPG Health - Date added 10 March 2018
AM Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date.
The STOP-AKI study demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint), it did show a significant, progressive and sustained improvement in renal function over the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without any observations of concern. The STOP-AKI data will be presented by the principle investigator Professor Pickkers at the AKI & CRRT conference in San Diego and at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) on March 21st in Brussels.
Comment: The intention of AM Pharma now is to move the program into a phase III study in consultation with clinical investigators, regulators and Pfizer, which took out an option on the company back in 2015.