|Gilead Sciences, Inc. (NASDAQ:GILD) confirms about Investigational and All-Oral Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C|
|By David Fowler|
|Thursday, 23 April 2015 13:57|
Gilead Sciences, Inc. (NASDAQ:GILD) has confirmed pre-clinical data as well as results from Phase 1 and Phase 2 studies which demonstrate development of an investigational all-oral as well as pan-genotypic regimen of Sovaldi. Sovaldi is the investigational NS5A inhibitor GS-5816 and GS-9857.
The data shall be disseminated at 50th Annual Meeting of European Association for Study of the Liver in Vienna, Austria. GS-9857 showed potent antiviral activity against HCV replicons along with an improved resistance profile vis-a-vis other HCV protease inhibitors in the preclinical study.
On the other hand, GS-9857 showed favourable pharmacokinetic profile from a healthy volunteer study. The information from three-day monotherapy study also showed that the inhibitor was well-tolerated besides achieving median HCV RNA reductions of over 3 log10 IU/mL for HCV patients.
ePoster, a Phase 2 study of triple-combination therapy having fixed-dose combination of SOF/GS-5816 plus GS-9857 for genotype 1 patients showed consistent virologic response rates after six weeks of treatment of 93 percent among treatment-naïve as well as non-cirrhotic patients.
Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences, opined that the data gives strength to current development of GS-9857 as well as the potential for all-oral, triple combination therapy having Sovaldi, GS-5816 and GS-9857 to attempt reducing treatment duration for hepatitis C patients.
He added that the firm is motivated due to six-week SVR12 rates as well as rest of the data at EASL showing regimen’s pan-genotypic potential. He also talked about the newly initiated additional Phase 2 studies for taking evaluation further for proper treatment duration of the regimen for all patients no matter what their genotype is and including those having failed prior therapy.
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