PARIS--(BUSINESS WIRE)--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, 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.
“Acute Liver Failure develops in a matter of days and requires immediate hospitalization. While some patients can undergo medical treatment, the majority need a high-risk liver transplant. ALF-5755 is a new milestone in the ongoing struggle against this pathology. The phase II clinical trial demonstrated the efficacy of this novel antioxidant in patients with HBV- and autoimmune- related acute on chronic liver diseases. This brings tremendous hope to clinicians and patients alike and represents a major step forward in the treatment of ALF,” commented Professor D. Samuel of the Paul Brousse Hospital in Villejuif, France.
Acute Liver Failure – ALF – is a rare condition in which the liver rapidly loses its ability to function, resulting in coagulopathy and alteration in the mental status of a previously healthy individual. Despite the improvement in overall survival in the last 20 years due to emergency interventions, ALF remains a life-threatening disease with about 30% of mortality rate. Hence, ALF remains a high unmet medical need.
For more information, please visit: http://www.alfactinnovation.com/