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news.Bristol-Myers Squibb has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents to treat HIV-1 infection in heavily treatment-experienced adult patients.
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The company said that BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor.
BMS-663068 is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell.
It is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks the entry into the cell.
The breakthrough designation is based on data from the Phase IIb trial comparing BMS-663068 to a boosted protease inhibitor (Reyataz and ritonavir) in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate.
Bristol-Myers Squibb Specialty Development head Douglas Manion said: "We are now 30-plus years into the AIDS epidemic, and there is an ever-increasing number of long-term survivors of the condition, many of whom are facing issues of drug resistance and are in need of new treatment options.
"The Breakthrough Designation recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients, and is evidence of Bristol-Myers Squibb’s continued focus on meeting that need."