Date: 2013-11-04
Type of information:
phase: 2
Announcement: results
Company: Alfact Innovation (France)
Product: ALF-5755 (recombinant protein of the human protein HIP/PAP)
Action mechanism:
Disease: acute liver failure
AIH- and HBV- related acute-on-chronic liver diseases
Therapeutic area: Hepatic diseases - Liver diseases
Country:
Trial details:
Latest
news: * On November 4 2013, Alfact Innovation, a young innovative biotechnology company focused on the discovery and the development of biopharmaceuticals to provide innovative therapies in hepatology and oncology disorders, has announced positive results from Phase II clinical trial for treatment of AIH- and HBV- related acute-on-chronic liver diseases. Alfact Innovation has developed ALF-5755, a recombinant protein of the human protein HIP/PAP with in vivo therapeutic effect on a fas model of Acute Liver Failure.
ALF-5755 was tested in 57 patients in a double blind controlled trial in European medical centers coordinated by Professor D. Samuel of the Paul Brousse Hospital in Villejuif, France. The patients were assigned to 2 pre-determined subgroups: 22 acute on chronic patients (9 AIH, 13 HBV), 35 acute patients (10 HAV, 8 drug-induced, 8 unknown, 9 other etiologies). ALF-5755 allowed a significant recovery of patients suffering from AIH- and HBV- related acute on chronic liver diseases and partially improved the condition of patients with other etiology-related acute liver failure. A biomarker (Gc Glo) was also identified to allow stratification of patients regarding liver transplantation requirement.
