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Novo Nordisk A/S (NVO) Chooses to Move Semaglutide Into Phase III Trials


6/22/2012 6:39:16 AM

BAGSVAERD, Denmark I June 21, 2012 I 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 I 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.

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,000 employees in 75 countries, and markets its products in more than 190 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com.

SOURCE: Novo Nordisk




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