Gilead Terminates Phase 2/3 Study of GS-5745 in Patients With Ulcerative Colitis
September 21 2016 - 5:00PM
Business Wire
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.
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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Gilead Sciences, Inc.Sung Lee, 650-524-7792InvestorsorNathan
Kaiser, 650-522-1853Media
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