BMS’ Investigational HIV Blocker Snags FDA Breakthrough Designation

Bristol-Myers Squibb has received breakthrough therapy designation from the FDA for its first-in-class investigational BMS-663068 compound for use in preventing HIV infection.

An attachment inhibitor, BMS-663068 is designed to work differently than entry inhibitors — the current standard of care for HIV treatment. While entry inhibitors target co-receptors’ activity after the HIV virus attaches to the immune host cell, attachment inhibitors are thought to block the virus’ entry into immune cells entirely, BMS said last week.

The breakthrough designation was based on data from a Phase 2b trial comparing BMS-663068 with a boosted entry inhibitor combo —BMS’ blockbuster HIV therapy Reyataz (atazanavir sulfate) and ritonavir — in treatment-experienced patients. BMS-663058 is designed for use with other retroviral agents to treat HIV-1 in this group of patients.

A Phase 3 trial in heavily treatment-experienced patients — those for whom drug combos don’t work well because of resistance, intolerability or contraindications — began in February and is ongoing.

Separately, BMS said its investigational HIV drug BMS-955176 performed well in a Phase 2a study. The drug is designed to prevent maturing of HIV-1, and when used with Reyataz produced a decline in HIV-1 RNA.

BMS is working hard on novel HIV therapies as Reyataz will face generic competition by 2017. The firm is entangled in a patent lawsuit with Mylan that, if successful, could open the door for a generic version even earlier. — Kellen Owings