GlaxoSmithKline presented data Monday at the American Diabetes Association annual meeting showing that five Phase III studies of the experimental glucagon-like peptide (GLP-1) receptor agonist albiglutide all met their main goal of change from baseline in HbA1c, compared with placebo or active comparators. Marketing applications for the once-weekly therapy are currently under review in the US and Europe after filings were made earlier this year.
The company noted that the Harmony 1 trial randomised patients inadequately controlled on a current regimen of Takeda's Actos (pioglitazone), with or without metformin, to receive albiglutide or placebo. Results at 52 weeks demonstrated that, in addition to the albiglutide combination therapy meeting the main endpoint, 44 percent of patients receiving GlaxoSmithKline's drug achieved an HbA1c target of less than 7 percent, compared with 15 percent of those on placebo. Meanwhile, the Harmony 2 study compared two doses of albiglutide to placebo in drug-naïve patients on diet and exercise. The company said that both doses of albiglutide showed significant HbA1c reductions over placebo at 52 weeks.
The drugmaker also indicated that in Harmony 3, which compared albiglutide, Merck & Co.'s Januvia (sitagliptin), glimepiride and placebo in patients who are taking and are inadequately controlled on metformin, reductions in HbA1c at 104 weeks for GlaxoSmithKline's therapy were significant versus all comparators. In addition, patients given albiglutide lost significantly more weight than those given glimepiride, while weight loss was similar versus Januvia and placebo. In the Harmony 4 trial, albiglutide was compared to Sanofi's Lantus (insulin glargine) in subjects on metformin, with or without a sulphonylurea. GlaxoSmithKline said that at 52 weeks, both patient groups achieved a similar reduction in HbA1c, with albiglutide showing non-inferiority to Lantus. Meanwhile, data demonstrated that patients taking albiglutide lost weight, while those given Lantus experienced weight gain, with a treatment difference of 2.6 kg.
In the Harmony 5 study, patients currently on a background therapy of metformin and glimepiride were randomised to receive albiglutide or placebo and Actos. According to GlaxoSmithKline, reductions in HbA1c in those given albiglutide were significant versus placebo at week 52, although non-inferiority was not achieved compared with Actos. The company added that gastrointestinal adverse events, including nausea, diarrhoea and vomiting, were higher in patients given albiglutide.
GlaxoSmithKline reported results last year from seven late-stage studies of albiglutide, which the company said supported regulatory filings for the drug, including data from the Harmony 6 trial. If approved, analysts predict albiglutide could generate annual sales of approximately $440 million by 2018. However, Bloomberg Industries analyst Sam Fazeli said "the data suggest that albiglutide is unlikely to be sufficient for it to be a serious competitor in the market." Fazeli added that "there is a small risk that the regulators would say that the the risk-benefit profile isn’t supportive of approval."
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