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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).