Gilead Sciences, Inc. (Nasdaq: GILD) today announced the initiation of a Phase 2 clinical trial evaluating GS-7340 for the treatment of HIV-1 infection in treatment-naïve adults. GS-7340 is a novel prodrug of tenofovir, the active agent in Viread® (tenofovir disoproxil fumarate). In previous studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that is ten times lower than Viread.
"The advancement of GS-7340 into this Phase 2 study is an important milestone in Gilead's efforts to develop the next generation of best-in-class therapies for HIV," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Because it can be used once-daily at one-tenth the dose of Viread, which is a much lower dose compared to other currently available anti-HIV compounds, GS-7340 could enable the development of a new range of single-tablet regimens for HIV that optimize clinical efficacy, safety and tolerability for patients."
The Phase 2 study will evaluate GS-7340 as part of a once-daily, co-formulated single-tablet regimen that will also contain the boosting agent cobicistat, the integrase inhibitor elvitegravir, and Emtriva® (emtricitabine). The GS-7340-containing single-tablet regimen will be compared to Gilead's Quad single-tablet regimen, which contains Viread and Emtriva (as Truvada®), elvitegravir and cobicistat, and is currently under review for marketing approval by U.S. and European regulatory agencies.
Gilead plans to initiate a second Phase 2 trial for GS-7340 later in 2012 that will assess GS-7340 as part of another single-tablet regimen containing cobicistat, Emtriva and Tibotec Pharmaceuticals' protease inhibitor Prezista® (darunavir). Gilead announced an agreement with Tibotec to develop this single-tablet regimen on November 15, 2011.
Viread was approved for HIV treatment in 2001 and has accumulated more than 4.4 million patient years of clinical experience to date.
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