The world's leading research-based pharmaceutical and healthcare company, GlaxoSmithKline has reported topline results from seven of the eight 'Harmony' Phase III studies investigating the use of albiglutide in type 2 diabetes.
Albiglutide is an investigational biological, injectable form of human GLP-1 and is not currently approved anywhere in the world. GLP-1 is a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. Normally, GLP-1 levels rise during a meal to help the body utilise and control the elevation in blood sugar levels. Albiglutide is an investigational medicine which fuses human GLP-1 to human albumin. It is designed to have the potential to extended duration of action and allow for weekly or less-frequent injections.
GSK is developing albiglutide as a once-weekly subcutaneous injection. All of the medication is contained within a proprietary injector pen for simple reconstitution and subcutaneous administration using a fine gauge needle by the patient.
The clinical development programme for albiglutide, comprises eight individual studies, known as Harmony 1 to Harmony 8. Results of Harmony Phase III programme studies are due to complete from late 2011 through early 2013. Harmony 6 and Harmony 7 have completed. One study (Harmony 8) will complete in 2012. The remaining five studies are expected to complete by early 2013.
The group says 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.
GSK anticipates data from both Harmony 6 and Harmony 7 will be presented at a scientific meeting in 2012.
On Monday the group increased its ownership in Theravance and entered into a stock purchase agreement, under which GSK will acquire 10,000,000 shares of Theravance common stock at a price of $21.2887 per share, for a total investment of $212,887,000.