Gilead Terminates Phase 2/3 Study of GS-5745 in Patients with Ulcerative Colitis

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis.
This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned
1600-patient trial were treated for an 8-week induction duration. The
DMC recommended that the study be terminated early due to meeting the
pre-specified futility and efficacy criteria. No safety concerns were
noted in this interim analysis. Gilead has also reviewed the data and
determined that there is insufficient evidence of a treatment benefit in
the group of patients randomized to receive either one of two doses of
GS-5745.
Separately, a Phase 3 study of GS-5745 is ongoing in patients with
gastric cancer, as well as a Phase 2 study in patients with gastric
cancer in combination with nivolumab and additional Phase 2 studies in
moderately to severely active Crohn’s disease, rheumatoid arthritis and
cystic fibrosis. These studies will continue as planned.
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,
California.
Forward-Looking Statement
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, including the
possibility of unfavorable results from other clinical trials for
GS-5745. In addition, it is possible that Gilead may make a strategic
decision to discontinue development of GS-5745 if, for example, Gilead
believes commercialization will be difficult relative to other
opportunities in its pipeline. As a result, GS-5745 may never be
successfully commercialized. 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 June 30, 2016, 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 statements.

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