Gilead Sciences (GILD) recently presented encouraging top-line data from a phase III study (Fusion), which evaluated its candidate sofosbuvir (formerly GS-7977) combined with ribavirin in patients suffering from genotypes 2 or 3 of the chronic hepatitis C virus (:HCV). The study evaluated patients who did not respond to prior therapies for the disease. The patients were evaluated at 12 and 16-week courses of the candidate. Through this study, Gilead is aiming to develop an all-oral treatment regimen to combat HCV.
The phase III study met its primary efficacy objective of superiority as opposed to a predefined historic control sustained virologic response rate of 25%. Moreover, sofosbuvir was found to be safe and well tolerated. None of the patients opted out from the study due to adverse events.
We note that apart from Fusion, Gilead is evaluating sofosbuvir in HCV patients in other phase III studies including Positron, Fission and Neutrino. Gilead intends to seek regulatory approvals for the candidate in the US and EU, based on data from the studies, in the second quarter of 2013.
Successful development of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A huge population suffers from HCV infection across the world. However, the treated population is much lower. This leaves the field open for new treatments. Moreover, the current standard of care comes with several side effects, which make it difficult for patients continue the treatment. Apart from Gilead, companies such as Johnson & Johnson (JNJ) are also developing therapies to combat HCV.
Gilead, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks, which are currently well placed, include Array Biopharma (ARRY) and Medivation, Inc. (MDVN). Both stocks carry a Zacks Rank #2.
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