GSK’s diabetes drug misses goal
pharmafile | April 4, 2012 | News story | Research and Development, Sales and Marketing | Bydureon, GSK, Victoza, albiglutide, diabetes
GlaxoSmithKline has insisted its new long-acting Type 2 diabetes drug albiglutide remains on course for filing following topline results from most of its Phase III programme.
Data has been received from seven out of the eight Harmony studies looking at albiglutide, an investigational once-weekly glucagon-like peptide-1 (GLP-1) agonist.
This is a relatively new class of injectable drugs which add to the existing choices of oral treatments and short and long-acting insulin products.
Designed to help patients reduce blood sugar levels (HbA1c) after they have failed on oral treatments, albiglutide is a planned rival to Lilly’s once-weekly injectable GLP-1 Bydureon (exenatide) – a long-acting form of its Byetta treatment.
But albiglutide’s progress has been viewed as shaky after disappointing data from one head-to-head trial last year with Novo Nordisk’s own once-daily GLP-1 analogue Victoza (liraglutide).
Harmony 7 showed a reduction in HbA1c of 0.78% for patients receiving albiglutide compared to a higher reduction of 0.99% for those in the Victoza arm, meaning GSK’s drug could not prove it was as good as Victoza.
While albiglutide did demonstrate a statistically significant reduction in HbA1c from baseline, it did not meet the primary endpoint of non-inferiority to Novo’s drug.
Victoza has already been approved by European and US regulators in combination with oral diabetes treatments metformin and sulphonylurea, or with glitazones such as Takeda’s Actos.
However, GSK is adamant that albiglutide will follow suit, saying the body of data from Harmony supports ‘progression towards regulatory filings’.
Harmony 6 compared albiglutide to preprandial insulin, each administered on top of long-acting insulin glargine, and showed a reduction in HbA1c from baseline of 0.82% in the albiglutide arm, compared to 0.66% for patients on preprandial lispro insulin.
Weight change from baseline was -0.73kg for patients taking albiglutide and +0.81kg in the other arm.
Data from Harmony 6 and 7 – the only studies to finish so far – will be presented at a scientific meeting this year.
Harmony 8 will end in the middle of the year, with the five other ongoing phase III studies finishing early in 2013 – making them the first studies of the effects of a GLP-1 agonist over three years.
GSK says final primary endpoint data up to two years must remain confidential, but that they are in line with the company’s expectations.
Adam Hill
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