December 18, 2006

GlaxoSmithKline (GSK) has confirmed that, due to insurmountable issues regarding formulation, development of brecanavir, an investigational protease inhibitor for the treatment of HIV, has been discontinued. Brecanavir was in Phase II clinical development.

Brecanavir had received fast-track designation from the FDA and was being developed by GSK as part of a collaboration with Vertex Pharmaceuticals.

Last year the companies presented data from a Phase IIb, open-label study evaluating the safety, tolerability, antiviral activity and pharmacokinetics of ritonavir-boosted brecanavir. Thirty-one HIV-1 infected adults received 300 mg of brecanavir twice-daily boosted with 100 mg of ritonavir in combination with two nucleoside reverse-transcriptase inhibitors based on patient medical history and viral genotype. A total of 81 percent of patients had plasma HIV-1 RNA below the level of detection of standard assays at week 24, and 77 percent had viral load below the level of detection of ultrasensitive assays.

Clinical trial investigators have been notified and directed to transition their patients to marketed antiretrovirals or appropriate treatments available through expanded access programs.

"GSK is dedicated to excellence in the care of individuals with HIV infection, and we will continue our efforts to find effective treatments with improved resistance profiles for these patients," Lynn Marks, senior vice president of GSKs Medicine Development Centre for Infectious Diseases, said. "Despite this disappointing outcome with brecanavir, we remain unwavering in our commitment to find new solutions to meet the challenges of HIV/AIDS."