GlaxoSmithKline ($GSK) has stumbled badly in its first late-stage study of albiglutide, a weekly GLP-1 diabetes drug. Reporting on the top-line results for the first of eight Phase III studies planned for albiglutide, the pharma giant reports today that the treatment flunked a head-to-head study with the daily Victoza, failing to match liraglutide's efficacy data.
GSK R&D chief Moncef Slaoui was putting a brave face on the setback, though. "This is the first of eight Phase III studies to conclude and we continue to look forward to receiving the results of the remaining studies which will provide a more complete assessment of the profile of albiglutide in type 2 diabetes," he said.
The weekly albiglutide was one of several late-stage treatments that have been angling to compete with current diabetes blockbusters as well as Bydureon, which has been badly slowed by the FDA. Roche's taspoglutide--licensed from Ipsen--had been one of the top contenders in the race, but the Big Pharma company dropped it after seeing troubling side effects in its own late-stage program. That failure left Lilly's ($LLY) LY2189265 as one other top contender.
GSK is committing a sizeable budget to albiglutide. This first Phase III recruited 841 patients from eight countries for 32 weeks of treatment. Like others in the field, GSK understands that the diabetes epidemic represents one of the biggest growth markets in pharma. Add up all the R&D work, though, and you have one of the most expensive--and frustrating--late-stage development races in the industry.
- here's the GSK release