Date: 2016-01-05
Type of information: Halting of the trial
phase: 2
Announcement: halting of the trial
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: idiopathic pulmonary fibrosis (IPF)
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country: Australia, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Republic of Korea, Spain, Switzerland, UK, USA
Trial details:
Latest
news: * On January 5, 2016, Gilead Sciences announced that the company is stopping its Phase 2 clinical study of simtuzumab among patients with idiopathic pulmonary fibrosis (IPF). This decision follows an analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. Gilead has also reviewed the data and determined the study has not shown evidence of a treatment benefit in the group of patients randomized to receive simtuzumab.
Separately, Phase 2 studies of simtuzumab are ongoing in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The DMC for these studies also met and recommended the continuation of the studies, which have a 96-week endpoint.
