January 05, 2016
Gilead Terminates Phase 2 Study of Simtuzumab in Patients With Idiopathic Pulmonary Fibrosis
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 5, 2016--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is
stopping its Phase 2 clinical study of the investigational monoclonal
antibody 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
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Gilead has operations in more
than 30 countries worldwide, with headquarters in Foster City,
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995, that
are subject to risks, uncertainties and other factors. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2015, as filed
with the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and
Gilead assumes no obligation to update any such forward-looking
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936