GlaxoSmithKline, Vertex's brecanavir suppresses HIV levels, study says

By Angela McDaniels

Seattle, Dec. 16 - GlaxoSmithKline Inc. and Vertex Pharmaceuticals Inc. said interim findings show that brecanavir, formerly known as GW640385 or VX-385, demonstrated potent antiviral activity in both protease inhibitor-sensitive and protease inhibitor-resistant HIV-infected adults.

"If approved, brecanavir may be useful in treating patients infected with strains of HIV that have become resistant to multiple protease inhibitors ... [brecanavir] is anticipated to enter phase 3 development in 2006," GlaxoSmithKline's senior vice president of infectious disease medicine development, Lynn Marks, said in a company news release.

The 24-week analysis is from a 48-week, open-label, phase 2b 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.

Out of 31 patients, 81% had plasma HIV-1 RNA below the level of detection of standard assays (<400 copies/mL of blood) at week 24 and 77% had viral load below the level of detection of ultrasensitive assays (<50 copies/mL), the company said.

Patients with protease inhibitor-sensitive and highly inhibitor-resistant virus had similar response rates. Improvements in immunologic status were observed, with a median increase in CD4+ cell count of 84 cells/mm3, the company said.

The data were presented at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy held in Washington, D.C.

A safety assessment showed that brecanavir was well-tolerated with few drug-related adverse events and no serious adverse events.

Brecanavir is an HIV protease inhibitor, which blocks the protease enzyme, yielding copies of HIV that cannot infect new cells.

Brecanavir has received fast track designation from the Food and Drug Administration and is being developed by GlaxoSmithKline as part of a collaboration with Vertex Pharmaceuticals.

Vertex is a biotechnology company based in Cambridge, Mass., that develops small molecule drugs for serious diseases.

GlaxoSmithKline is a pharmaceutical company with U.S. operations in Philadelphia and Research Triangle Park, N.C.

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