The FINANCIAL — Bristol-Myers Squibb Company (NYSE:BMY) on Ferbruary 15 announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients.
In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor (Reyataz (atazanavir sulfate) and ritonavir), virologic response rates (HIV-1 RNA <50 c/mL) and immunologic reconstitution were similar across the BMS-663068 and Reyataz/ritonavir arms of the trial through 48 weeks. Specifically, 61-82% of BMS-663068 patients had HIV-1 RNA levels <50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48 (mITT FDA snapshot analysis). HIV-1 RNA levels <50 c/mL typically indicate virus replication is undetectable.
Treatment with BMS-663068 resulted in no dose response safety signals, no treatment discontinuations related to adverse events (AEs), and no treatment-related serious adverse events over the course of the trial. The most common AEs were headache (2% in the 800 mg cohort) and abdominal pain (2% in 1200 mg cohort), according to Bristol-Myers Squibb.
Due to the positive results seen thus far, a Phase III clinical trial of the attachment inhibitor among heavily treatment-experienced patients began on Monday, February 23, 2015. For the purposes of the Phase III trial, heavily treatment-experienced patients are defined as individuals who can no longer formulate a viable regimen (standard three-course treatment regimen) due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications.
“The attachment inhibitor clinical development program exemplifies our commitment to focusing on patients living with HIV who have high unmet needs,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “This development is representative of a continued effort at Bristol-Myers Squibb to find innovative approaches to fighting this disease.”
The Phase IIb study results, presented yesterday at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI), highlight the novel mechanism of action of the investigational prodrug BMS-663068, which when converted into its active moiety BMS-626529, is designed to bind directly to the HIV gp120 protein, and prevents initial viral attachment to the host CD4+ T cell and entry into the host immune cell.
“Today, due to tremendous advancements in therapy, many patients living with HIV are able to remain healthier and live longer; however, this means that they are usually exposed to multiple therapies over time, and may often develop drug resistance,” said Jacob Lalezari, M.D., Director of Quest Clinical Research and an Assistant Clinical Professor of Medicine at the University of California-San Francisco/Mount Zion Hospital. “Treatment-experienced patients represent an important patient subset, for whom ongoing research and development of new drug classes is being actively pursued.”
Discussion about this post