US biotech Gilead Sciences (Nasdaq: GILD) has presented new data
showing positive signs on treatments it is developing for the liver
conditions nonalcoholic steatohepatitis (NASH) and primary sclerosing
cholangitis (PSC).
The findings, which were presented at the International Liver Congress 2016 in Barcelona, Spain, support the continuation of studies of simtuzumab, GS-4997 and GS-9674, investigational compounds for the treatment of NASH and PSC.
NASH is a serious liver disease resulting from metabolic dysfunction that is associated with steatosis – fat within the liver – along with inflammation and fibrosis, which may progress to cirrhosis. By 2020, NASH-related cirrhosis is expected to become the leading indication for liver transplantation.
PSC is characterized by inflammation and stricturing of the bile ducts. The disease can eventually lead to cirrhosis and other complications, including bile duct cancer.
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. Gilead is testing simtuzumab for the treatment of fibrosis in patients with NASH and PSC in three ongoing Phase IIb clinical trials.
Data evaluating the associations between clinical features, liver histology and portal pressure at baseline in patients with NASH and PSC supported correlations between PSC-related liver fibrosis assessed histologically and non-invasive markers such as serum levels of LOXL2 and liver stiffness by transient elastography.
An additional study 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.
Norbert Bischofberger, chief scientific officer at Gilead, said: “The data presented enhance our understanding of the pathogenesis of NASH and PSC - two progressive liver diseases for which there are no approved treatment options. We are committed to advancing the treatment of NASH and PSC by targeting multiple core pathways associated with metabolic dysfunction, inflammation and fibrosis. We are encouraged by the data and look forward to applying the scientific insights from these and other ongoing studies to enhance our clinical programs.”
Topline safety and efficacy data from the Phase IIb studies of simtuzumab for the treatment of NASH and PSC are anticipated by the end of 2016.
In January, Gilead stopped a Phase II study into the investigational monoclonal antibody after evidence emerged that the treatment did not benefit patients. Simtuzumab was being trialled in that instance on patients with idiopathic pulmonary fibrosis (IPF) but data revealed a lack of efficacy.
The findings, which were presented at the International Liver Congress 2016 in Barcelona, Spain, support the continuation of studies of simtuzumab, GS-4997 and GS-9674, investigational compounds for the treatment of NASH and PSC.
NASH is a serious liver disease resulting from metabolic dysfunction that is associated with steatosis – fat within the liver – along with inflammation and fibrosis, which may progress to cirrhosis. By 2020, NASH-related cirrhosis is expected to become the leading indication for liver transplantation.
PSC is characterized by inflammation and stricturing of the bile ducts. The disease can eventually lead to cirrhosis and other complications, including bile duct cancer.
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. Gilead is testing simtuzumab for the treatment of fibrosis in patients with NASH and PSC in three ongoing Phase IIb clinical trials.
Data evaluating the associations between clinical features, liver histology and portal pressure at baseline in patients with NASH and PSC supported correlations between PSC-related liver fibrosis assessed histologically and non-invasive markers such as serum levels of LOXL2 and liver stiffness by transient elastography.
An additional study 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.
Norbert Bischofberger, chief scientific officer at Gilead, said: “The data presented enhance our understanding of the pathogenesis of NASH and PSC - two progressive liver diseases for which there are no approved treatment options. We are committed to advancing the treatment of NASH and PSC by targeting multiple core pathways associated with metabolic dysfunction, inflammation and fibrosis. We are encouraged by the data and look forward to applying the scientific insights from these and other ongoing studies to enhance our clinical programs.”
Topline safety and efficacy data from the Phase IIb studies of simtuzumab for the treatment of NASH and PSC are anticipated by the end of 2016.
In January, Gilead stopped a Phase II study into the investigational monoclonal antibody after evidence emerged that the treatment did not benefit patients. Simtuzumab was being trialled in that instance on patients with idiopathic pulmonary fibrosis (IPF) but data revealed a lack of efficacy.
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