Gilead Sciences Inc is discontinuing its development programmes for GS 9005 and GS 7340, two investigational products for the treatment of HIV. The company will continue to focus its research efforts on multiple targets for HIV, including protease inhibitors, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors and fusion inhibitors, as well as hepatitis C virus (HCV) and diseases of the lymphatic system, the company has announced here.
Gilead completed its investigational new drug (IND) application for GS 9005, a protease inhibitor, in December 2003, and shortly thereafter initiated studies to assess the oral bioavailability, pharmacokinetics, safety and efficacy of the compound. Gilead recently completed a phase I/II viral dynamics study that did not demonstrate a sufficient antiviral response after administration of GS 9005. These results were consistent with the observed low oral bioavailability in an earlier phase I study.
GS 7340, Gilead's investigational anti-HIV agent in phase I/II studies, is a prodrug of tenofovir, the active agent in the company's HIV drug Viread (tenofovir disoproxil fumarate). Based on the safety, tolerability and efficacy of Gilead's HIV products established in clinical studies and commercial use, Gilead does not believe that GS 7340 has a profile that differentiates it to an extent that supports its continued development.
"We continue to be dedicated to the development of therapeutic advances for the treatment of HIV, with ongoing research programs focused on existing and novel targets, hepatitis C and diseases of the lymphatic system," said John C Martin, president and CEO of Gilead Sciences, Inc.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has seven marketed products and focuses its research and clinical programmes on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in North America, Europe and Australia.