-- Sustained Virologic Response Achieved with Oral Regimen of
Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1
Hepatitis C Patients -- -- Second Phase 3 Study Evaluating Fixed-dose Combination of
Sofosbuvir and GS-5885 to Begin Later this Month --
Gilead Sciences (Nasdaq:GILD) today announced several updates regarding
its late-stage pipeline candidates for the treatment of chronic
hepatitis C virus (HCV) infection. The company released new results from
an arm of the ongoing Phase 2 ELECTRON study examining the nucleotide
sofosbuvir and the NS5A inhibitor GS-5885, and provided a progress
report on a range of Phase 2 and 3 clinical trials evaluating a
once-daily fixed-dose combination tablet of these medicines. These
updates will be highlighted today as part of Gilead’s corporate
presentation at the 31st Annual J.P. Morgan Healthcare Conference taking
place in San Francisco.
“Since the acquisition of Pharmasset only a year ago, we have fully
enrolled four Phase 3 studies of sofosbuvir and during the first quarter
of this year we will have initiated two Phase 3 studies of the
sofosbuvir and GS-5885 fixed-dose combination,” said Norbert
Bischofberger, PhD, Executive Vice President, Research and Development
and Chief Scientific Officer, Gilead Sciences. “We are on track to
submit the initial regulatory filing for sofosbuvir by mid-2013 and to
file for approval of the fixed-dose combination of sofosbuvir and
GS-5885 in 2014.”
Update on Phase 2 ELECTRON Study
Gilead today announced full data from one cohort of the ongoing Phase 2
ELECTRON study examining a 12-week course of all-oral therapy with
sofosbuvir, GS-5885 and ribavirin (RBV) among genotype 1 HCV patients
who had previously failed to respond to an interferon (IFN)-containing
regimen, or “null responders.”
Preliminary data, presented in November at the annual meeting of the
American Association for the Study of Liver Diseases (AASLD),
demonstrated that three of nine patients (3/9) remained HCV RNA
undetectable four weeks after completing therapy (SVR4). Today’s
announcement confirms that all nine patients (9/9) in this cohort
achieved SVR4. These patients will continue to be observed to determine
sustained virologic response rates at weeks 12 and 24 of follow-up
(SVR12 and SVR24).
Results from eight other arms of the ELECTRON study, evaluating
sofosbuvir alone and with RBV and/or pegylated IFN, were published
earlier this month in the New England Journal of Medicine (N Engl
J Med 368;34-44).
Advancing a Fixed-Dose Combination Tablet for
HCV
Gilead is currently evaluating a once-daily fixed-dose combination
tablet containing sofosbuvir and GS-5885 in several Phase 2 and 3
trials. The studies evaluate sofosbuvir/GS-5885 with and without RBV
among a range of genotype 1 HCV patient populations.
-
ION-1: This Phase 3 trial was initiated in October 2012
and is evaluating sofosbuvir/GS-5885 with and without RBV for 12 or 24
weeks among treatment-naïve genotype 1 patients. Pending a review of
results from the two 12-week arms (n=50/arm) of an initial enrollment
of 200 patients, ION-1 will continue to recruit patients and assess
sofosbuvir/GS-5885 in a total of 800 individuals.
-
ION-2: Gilead today announced that a second Phase 3
study for sofosbuvir/GS-5885, ION-2, is expected to begin screening
patients in January 2013. This study will evaluate the fixed-dose
combination, with RBV for 12 weeks and with and without RBV for 24
weeks of therapy among 400 treatment-experienced genotype 1 HCV
patients. Participants in this study will have failed past therapy
with regimens containing IFN or IFN plus a protease inhibitor.
-
LONESTAR: Gilead also announced that enrollment is now
underway for a new Phase 2 study of sofosbuvir/GS-5885 for 12 weeks
and of sofosbuvir/GS-5885 with and without RBV for 8 weeks among
genotype 1 treatment-naïve patients. Two additional arms in this trial
will evaluate sofosbuvir/GS-5885 with and without RBV for 12 weeks
among treatment-experienced genotype 1 patients who had previously
received a protease inhibitor-containing regimen. This study, which
will enroll 100 patients, is the first trial to evaluate the
combination of sofosbuvir and
GS-5885 for only eight weeks of
treatment.
Sofosbuvir, GS-5885 and the fixed-dose combination tablet are
investigational products and their safety and efficacy have not yet been
established.
Four ongoing Phase 3 studies will support Gilead’s initial regulatory
filing in mid-2013 for an all-oral therapy with sofosbuvir plus RBV
among genotype 2/3 treatment-naïve, treatment-experienced and
interferon-intolerant patients, and for sofosbuvir in combination with
RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4,
5 and 6. Topline results from the first Phase 3 study, POSITRON, were
announced in November 2012, and results from the remaining three studies
(FISSION, FUSION and NEUTRINO) are anticipated in Q1 2013. Results from
ION-1, ION-2 and LONESTAR are intended to support a regulatory filing
for the fixed-dose combination of sofosbuvir/GS-5885 by mid-2014.
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. Headquartered in Foster City,
California, Gilead has operations in North America, Europe and Asia
Pacific.
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 that the proportion of patients who maintain a sustained
virologic response 12 and 24 weeks post-treatment in the null responder
arm of the ELECTRON study will not be as favorable as the sustained
virologic response rates reported in this press release, and the
possibility of unfavorable results from additional arms of ELECTRON and
other clinical trials involving sofosbuvir and sofosbuvir and GS-5885
with and without RBV. As a result, sofosbuvir and GS-5885 as single
agents or as a fixed-dose combination may never be successfully
commercialized. In addition, Gilead may make a strategic decision to
discontinue development of the compounds or the fixed-dose combination
regimen if, for example, Gilead believes commercialization will be
difficult relative to other opportunities in its pipeline. Further,
Gilead may be unable to file for regulatory approval of sofosbuvir and
the fixed-dose combination of sofosbuvir/GS-5885 in the currently
anticipated timelines or at all. If marketing approval is granted for
any of these products, there may be significant limitations on their
use. 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, 2012, 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.
