|BMS' Douglas Manion|
Bristol-Myers Squibb ($BMY) has nabbed a breakthrough therapeutic designation for a next-gen HIV therapy aimed at offering an option for patients who become resistant to the therapies now in use.
Bristol-Myers, which has been aggressively muscling ahead with new work on its PD-1 cancer blockbuster Opdivo, now gains an inside track at the agency for BMS-663068, an oral "attachment inhibitor" that has demonstrated promising results in a Phase IIb trial. Now in Phase III, Bristol-Myers is on a path that could lead to an accelerated approval for the drug.
There's already a class of entry inhibitors that is designed to bar the virus's access to immune cells. Last February, Bristol-Myers reported 48-week data on their drug, which compared favorably with the protease inhibitor Reyataz. BMS-663068 is a prodrug which, when converted into BMS-626529, binds to the HIV gp120 protein and blocks the viral attachment to the host CD4+ T cell, preventing entry into the host immune cell.
The safety data in the study--which recruited 254 patients--was also promising, setting up a clean shot at pivotal data.
HIV cocktails have been in use for decades now, quelling the disease in most cases without actually eradicating HIV, leaving patients at risk of a viral breakout that could kill them. While scientists are still at work on better therapies and a vaccine that could wipe out HIV, drugmakers like Bristol-Myers have continued to operate a pipeline of new drugs for treatment-resistant patients.
"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, head of specialty development at Bristol-Myers Squibb. The Breakthrough Designation recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients."
- here's the release