PRINCETON, N.J. -- (BUSINESS WIRE) -- Bristol-Myers Squibb Company (NYSE:BMY) today presented 24-week Phase IIb data that demonstrated similar response rates (HIV-1 RNA <50 c/mL) for its investigational compound, BMS-663068, when compared to a boosted protease inhibitor, Reyataz® (atazanavir sulfate) with ritonavir. Among HIV-1 infected treatment-experienced patients receiving BMS-663068, 69-80% had HIV-1 RNA levels of <50 c/mL (a measure indicating virus replication is undetectable), compared to 75% of patients taking Reyataz with ritonavir. Presented at the 21st Conference on Retroviruses and Opportunistic Infections (CROI) today, this study highlights the unique mechanism of action of the investigational prodrug BMS-663068, which when converted into BMS-626529, a novel attachment inhibitor, prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
Globally, there are 34 million people who are infected with HIV. Due to significant scientific advances in management of HIV treatment over the last 20 years, patients are now living with HIV for a longer period of time and some patients have developed resistance to existing regimens or are unable to tolerate current available treatments. Additional treatment options, especially in new drug classes, are needed both today and into the future for these patients.
“By targeting the virus at an earlier step of the viral lifecycle, BMS-663068 disrupts the virus in a way unlike existing antiretroviral agents,” said Jacob P. Lalezari, M.D., director of Quest Clinical Research and assistant clinical professor of medicine at UCSF/Mount Zion Hospital. “The data suggest that BMS-663068 is potentially as effective as one of the current standards of care and may provide another method of suppressing the virus in treatment-experienced patients who have failed a prior HIV regimen and need new treatment options.”
Study Design and Results
In this active-controlled Phase IIb study, treatment-experienced HIV-1 infected adults (n=254) were randomized equally to one of four BMS-663068 treatment arms: (400 mg BID (twice daily); 800 mg BID; 600 mg QD (once daily); 1200 mg QD) and, a control group of Reyataz® (atazanavir sulfate) and ritonavir (300/100 mg QD). Each treatment arm and the control group also included raltegravir (RAL) 400 mg BID and tenofovir disoproxil fumarate (TDF) 300 mg QD. The primary endpoints were the proportion of subjects with HIV-1 RNA <50 c/mL at week 24 and the frequency of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation through week 24.
Through week 24, BMS-663068 showed similar efficacy compared to Reyataz and ritonavir for treatment-experienced patients infected with HIV-1. Specifically, 69-80% of patients in the four treatment arms had HIV-1 RNA levels <50 c/mL, indicating virus replication was undetectable, compared to 75% of patients in the control group.
BMS-663068 was generally well-tolerated during the study, with no serious adverse events attributed to BMS-663068 nor any adverse events leading to discontinuation. The incidence of Grade 2-4 related AEs across BMS-663068 arms ranged from 3.9% to 12%, vs. 27.5% in the comparator arm (atazanavir sulfate and ritonavir) and no causal association was observed between adverse events and BMS-663068 dose.
“These study results are encouraging and support further development of BMS-663068 as we continue to look for ways to treat people living with HIV, especially those who have exhausted available therapies and are difficult to treat,” said Douglas Manion, M.D., senior vice president, Development, Virology, Bristol-Myers Squibb. “Bristol-Myers Squibb is committed to the fight against HIV and continues to study treatments with novel mechanisms of action in hopes of addressing the unmet needs of both patients recently diagnosed with HIV, treatment-naïve and treatment-experienced HIV-infected individuals throughout the world.”
About Bristol-Myers Squibb’s HIV Research Portfolio
For over 20 years, Bristol-Myers Squibb has focused on discovering, developing and delivering innovative medicines to help meet the needs of patients living with HIV/AIDS and continues to pursue advances in treatment, for both children and adults with HIV. Studies are ongoing for new treatments including an NRTI (BMS-986001), an attachment inhibitor prodrug (BMS-663068) and a maturation inhibitor (BMS-955176).
Bristol-Myers Squibb also continues to enhance its current product offerings for patients living with HIV/AIDS and is developing a fixed-dose combination of Reyataz® (atazanavir sulfate) and Gilead’s investigational drug cobicistat, which is currently in Phase III development. New bioequivalence (BE) data about this combination will also be featured in a poster presentation on March 6 at 2:30 p.m. during the 2014 Conference on Retroviruses and Opportunistic Infections.
INDICATION and IMPORTANT SAFETY INFORMATION about
REYATAZ (atazanavir sulfate) 200mg/300mg Capsules:
REYATAZ® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for treatment of HIV-1 infection. This is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks (treatment-naive) and 48 weeks (treatment-experienced) duration in adult and pediatric patients at least 6 years of age. The following should be considered when initiating REYATAZ:
IMPORTANT SAFETY INFORMATION:
See Section 7 (including Table 13), of the Full Prescribing Information for additional established and other potentially significant drug interactions, and related dose modification recommendations.
Please see accompanying Full Prescribing Information here.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compounds mentioned will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.