Ph III albiglutide data in type 2 diabetes supports move to filing, says GSK

UK pharma giant GlaxoSmithKline plc (LSE: GSK) says that top-line results have been received from seven of the eight Harmony Phase III studies investigating the use of albiglutide in type 2 diabetes, which it believes support progression toward regulatory filing of the product.

Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist created by USA-based Human Genome Sciences (Nasdaq: HGSI) using its proprietary albumin-fusion technology, and was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million in addition to single-digit net royalties on worldwide sales if albiglutide is commercialized.

In Harmony 6, the second of the Phase III Harmony studies to complete, albiglutide was compared to pre-prandial insulin, each administered on top of long-acting insulin glargine. In this study, the first of its kind for the class, albiglutide produced clinically significant reductions in HbA1c from baseline and non-inferiority versus pre-prandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint.