GlaxoSmithKline (NYSE:GSK) has stumbled in its efforts to develop a once-weekly injectable type 2 diabetes drug that would offer a dosing advantage over a comparable once-a-day drug sold by Novo Nordisk (NYSE:NVO).
GSK’s albiglutide failed to demonstrate it was as effective as Novo Nordisk’s victoza in a phase 3 clinical trial that pit the two injectables head-to-head. GSK will move forward on further studies of the drug; the failed trial was the first of eight clinical trials planned for albiglutide.
British drug company GSK has its U.S. headquarters in Research Triangle Park, North Carolina. If the pharmaceutical giant can take solace in anything from the results so far, it’s that the drug appeared to have no serious side effects. The most common adverse events were gastrointestinal tolerability, but nausea and vomiting were lower in albiglutide compared to the Novo Nordisk product. Drug safety remains a major concern for all pharmaceutical companies that develop diabetes drugs and it is top of mind for GSK, which saw former diabetes blockbuster drug Avandia all but barred from the market last year amid growing patient and regulator concerns over cardiovascular risks linked to the product.
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GSK said that detailed analysis of the failed trial will be conducted and presented at a scientific meeting in 2012. Initial results from the remaining seven phase 3 albiglutide studies will be made available over the next several months. The company expects to provide an update on the clinical program in mid-2012.
Albiglutide is a biological, injectable form of human GLP-1, a peptide that helps the body maintain normal blood-sugar levels and also helps control appetite. People who have type 2 diabetes experience reduced GLP-1 secretion in response to a meal. Albiglutide fuses human GLP-1 to human albumin, which is intended to potentially extend the duration of the drug which means patients would need less frequent injections.
The phase 3 program is investigating albiglutide as a mono- or add-on therapy for patients with type 2 diabetes. In addition to head-to-head studies against Novo Nordisk’s victoza, phase 3 studies of the GSK drug candidate will match albiglutide against other diabetes drugs. GSK said that besides the head-to-head study against victoza, another study is expected to be complete in late 2011. Yet another study will be completed in 2012 and the remaining five are expected to finish by early 2013.
