Novo Nordisk to initiate phase 3 development of semaglutide

Novo Nordisk today announced the decision to initiate the global phase 3 development programme for semaglutide, a once-weekly human GLP-1 (Glucagon-Like Peptide-1) analogue.

Semaglutide successfully completed phase 2 development in 2010. At that time, it was decided to compare semaglutide with a once-weekly formulation of liraglutide being studied in phase 1 trials before selecting a candidate for phase 3 development. Liraglutide is the active component in Victoza®, Novo Nordisk’s once-daily human GLP- 1 product.

These, now completed, phase 1 trials reconfirmed the safety profile of liraglutide, but semaglutide has been assessed to have a more attractive profile for once-weekly administration. Consequently, Novo Nordisk has decided to focus on further development of semaglutide, while no further clinical activities with the once-weekly version of liraglutide are expected.

“We are excited about the opportunity that semaglutide represents to further improve type 2 diabetes therapy within the GLP-1 class,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The clinical data for semaglutide, in terms of glucose control, weight loss and a low level of hypoglycaemic events after weekly dosing, hold great promise for a differentiated profile and improvement to the treatment of patients with type 2 diabetes”.

Novo Nordisk now plans to initiate the first phase 3 study in the SUSTAIN™ programme in the first half of 2013. The global clinical development programme is expected to include more than 8,000 patients.

About Victoza® (liraglutide)

Victoza® is a human GLP-1 analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and to suppress glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.

Victoza® has been commercially launched in more than 50 countries globally, including the US, China, Japan, the Arabian Peninsula and a number of countries in Europe, Asia and South America. It will be available in other markets throughout 2012.

About semaglutide

Semaglutide is a human GLP-1 analogue developed for once-weekly treatment of type 2 diabetes patients. The mechanism behind blood glucose lowering and reduction of body weight follows the same principles as liraglutide; however, with a longer intrinsic circulation half-life. Hence, the semaglutide molecule has a pharmacokinetic profile particularly suitable for once-weekly subcutaneous administration.