BMS gets FDA Breakthrough Therapy Designation for investigational HIV treatment

WASHINGTON - July 23, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Therapy Designation to Bristol-Myers Squibb’s investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in treatment-experienced adult patients. BMS-663068 is a first-in-class HIV-1 attachment inhibitor and functions differently than other entry inhibitors, the compound works earlier in the replication process by preventing the virus’ initial interaction with immune cells therefore, blocking the virus’ entry into the healthy cell.

The Phase IIb clinical study compared BMS-663068 to a protease inhibitor (Reyataz^® (atazanavir sulfate) and ritonavir) in treatment-experienced adult patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate. At week 48, results from the study were presented at the 22^nd Conference on Retroviruses and Opportunistic Infections (CROI) encouraging continued clinical development of the attachment inhibitor.

“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,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “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.”

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