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Gilead Presents Preliminary Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIVGilead Sciences, Inc. today announced data from four pre-clinical and Phase 1 studies evaluating bictegravir (GS-9883), a novel, unboosted, investigational once-daily integrase strand transfer inhibitor (INSTI). The studies, which examined the antiviral potency, resistance profile, pharmacokinetics and safety of bictegravir, were presented this weekend during a poster session at the American Society of Microbiology (ASM (News - Alert)) Microbe 2016 Conference in Boston. Bictegravir is currently in Phase 3 trials as part of a single tablet regimen in combination with tenofovir alafenamide (TAF) and emtricitabine (FTC (News - Alert)) for the treatment of HIV-1 infection (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). "We are pleased to share initial results from the bictegravir clinical program, including data from the first Phase 1 human trial, which provided proof of concept for further evaluation of bictegravir as part of a single tablet regimen," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "Bictegravir represents Gilead's ongoing efforts to develop new therapies with the potential to improve upon currently available treatments and address the unmet needs of people living with HIV." Bictegravir (GS-9883) Data at ASM Poster 413: Bictegravir (GS-9883), a Novel HIV-1 Integrase Strand Transfer Inhibitor (INSTI) with Optimized In Vitro Resistance Profile
Poster 414: Discovery of GS-9883, an HIV-1 Integrase Strand Transfer Inhibitor (INSTI) with Improved Pharmacokinetics and In Vitro Resistance Profile
Poster 416: Antiviral Activity of GS-9883, a Potent Next-Generation HIV-1 Integrase Strand Transfer Inhibitor
Further information about the clinical studies described above can be found at www.clinicaltrials.gov. Bictegravir, including in combination with TAF and FTC as a single tablet regimen, is an investigational treatment for HIV that has not been determined to be safe or efficacious. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from other clinical trials involving bictegravir. As a result, bictegravir may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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