GlaxoSmithKline plc (GSK,GSK.L) said topline results have been received from seven of the eight 'Harmony' Phase III studies investigating the use of albiglutide in type 2 diabetes. According to the company, data from seven studies support progression towards regulatory filings.
The Harmony programme was designed to permit assessment of safety and durability of glycemic control after long-term use. The studies will provide data on the effect of albiglutide over three years.
GSK announced that 2 year data read-outs from five ongoing phase III studies, ie, Harmony 1 through Harmony 5, have been received. These read-outs present the final results for primary endpoint data up to two years. The company indicated that the two year data support progression and will be used for regulatory filings.
GSK has now reviewed primary endpoint data on the efficacy and safety of albiglutide, verses placebo and active controls, across seven Phase III studies. The data reviewed to date support progression to regulatory submissions, as a possible once-weekly treatment for type 2 diabetes. As well as the full data set from Harmony 6, 7 and 8 and the 2 year data currently in-house from the five ongoing studies, a meta-analysis of cardiovascular safety data will be required to complete the registration package, consistent with FDA guidelines. Harmony 8 will complete in mid 2012 and the five ongoing studies will complete in early 2013.
Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist.
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