AM-Pharma strives to develop medicines for patients confronted with severe medical conditions. Our proprietary asset, ilofotase alfa, is initially being developed for the treatment of patients with acute kidney injury and has been granted FDA fast-track status. With approximately 1000 patients evaluated to date in clinical trials, ilofotase alfa has a proven safety profile and a demonstrated kidney benefit. We are a dedicated team driven to bring treatment options to severely ill patients, their families and acute care professionals.
Acute Kidney Injury (AKI)
OUR AKI PIPELINE
PHASE III STUDY REVIVAL UPDATE
We are finalizing 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, ilofotase alfa, for the treatment of patients with SA-AKI. The study stopped per recommendation of the data monitoring committee after per-protocol pre-specified interim futility analysis on the study’s primary endpoint, 28-day mortality, without any safety concern. After review of the unblinded data for all 649 patients in the study at the time of termination, the data showed a nominally significant reduction in Major Adverse Kidney Events by day 90. The Company intends to progress its research and development of ilofotase alfa in acute kidney injury. Further information on this study can be found at NCT04411472 (REVIVAL).
Further data will be published in a peer-reviewed journal and at scientific conferences in the first half of 2023.