Date: 2016-04-16
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at The International Liver Congress 2016 in Barcelona, Spain
Company: Gilead Sciences (USA - CA)
Product: simtuzumab
Action
mechanism: monoclonal antibody. Simtuzumab is a monoclonal antibody that is selective for lysyl oxidase-like-2 (LOXL2), an extracellular matrix enzyme that promotes fibrosis via the cross-linkage of collagen fibers.
Disease: NASH (non-alcoholic steatohepatitis), primary sclerosing cholangitis (PSC)
Therapeutic area: Liver diseases - Hepatic diseases
Country:
Trial details:
Latest
news: * On April 16, 2016, Gilead Sciences announced data supporting the development of simtuzumab for the treatment of nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The data were presented in oral and poster sessions at The International Liver Congress 2016 in Barcelona, Spain. Data evaluating the associations between clinical features, liver histology and portal pressure at baseline in patients with NASH and PSC were presented in multiple poster sessions (Poster THU-016, Poster THU-369, Poster FRI-324, Poster FRI-350, Poster FRI-375 and Poster SAT-400). The data support the correlations between PSC-related liver fibrosis assessed histologically and noninvasive markers (e.g., serum levels of LOXL2 and liver stiffness by transient elastography). An additional study presented during an oral session identified novel genetic polymorphisms associated with liver fibrosis and serum levels of LOXL2 in patients with PSC, which may help identify patients with an increased risk of disease progression (Oral PS-093). These studies were led by Christopher Bowlus, MD, University of California, Davis, Sacramento, California (FRI-375); Zachary Goodman, MD, PhD, Inova Fairfax Hospital, Falls Church, Virginia (SAT-400); Andrew Muir, MD, Duke Clinical Research Institute, Durham, North Carolina (FRI-350); Arun Sanyal, MD, Virginia Commonwealth University, Richmond, Virginia (THU-016); and Patrick Shea, PhD, Institute for Genomic Medicine at Columbia University, New York, New York (THU-369; FRI-324; Oral PS-093). Topline safety and efficacy data from the Phase 2b studies of simtuzumab for the treatment of NASH and PSC are anticipated by the end of 2016.
