Gilead Sciences 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.
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.
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