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Gilead terminates Phase II simtuzumab IPF study

pharmafile | January 6, 2016 | News story | Research and Development Gilead, IPF, idiopathic pulmonary fibrosis, simtuzumab 

Gilead Sciences has announced the termination of its Phase II clinical study of the investigational monoclonal antibody simtuzumab in patients with idiopathic pulmonary fibrosis (IPF), after the dug failed to deliver benefit. 

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 randomised to receive simtuzumab. 

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 randomised to receive simtuzumab.

The compound also failed in Phase II pancreatic cancer trials in 2014, proving not to extend survival in previously-untreated patients. Gilead continues to study simtuzumab in indications including non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

The DMC for these studies also met and recommended the continuation of the NASH and PSC studies, which have a 96-week endpoint.

Joel Levy

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