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Novo Nordisk’s next-gen GLP-1 aces late-stage trial

Firm hopes semaglutide will shore up future sales of its diabetes range

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Novo Nordisk's new long-acting GLP-1 diabetes medicine semaglutide has passed a key late-stage trial as the firm looks to it to become its next big earner.

The Danish diabetes specialist said that data from SUSTAIN1, the first phase III trial for semaglutide - its new GLP-1 analogue that is administered once-weekly, showed it could help type II diabetes patients lower their blood sugar levels.

The study looked at the drug in a 0.5mg and 1.0mg dose as a monotherapy during 30 weeks of treatment, and compared it with placebo in 388 people with type II diabetes previously on diet and exercise.

The data showed that 74% and 73% of the people treated with the low and higher doses of semaglutide, respectively achieved the American Diabetes Association and the European Association for the Study of Diabetes treatment target of blood sugar levels (HbA1c) below 7%, compared with 25% of the people treated with placebo.

Furthermore, from a mean baseline of 92 kg, people treated with semaglutide in both doses of 0.5mg and 1.0mg experienced a superior weight loss of 3.8kg and 4.6kg, respectively, compared with a weight loss of 1.0kg for people treated with placebo.

The drug is in the running follow the success of Victoza (liraglutide), the firm's first GLP-1. The once-daily treatment currently makes Novo around $2bn a year. 

As semaglutide is taken just once a week, this may prove a more attractive option for patients, as it would require fewer injections. 

Should it gain approval, the drug will have to help Novo keep its position as the world's largest diabetes firm by revenue, and in a market that has become highly competitive.

Mads Krogsgaard Thomsen, executive VP and chief science officer of Novo Nordisk, said: "We are excited about these results, which confirm that semaglutide has the potential to help people with type 2 diabetes achieve both good glycaemic control and a significant weight loss with one weekly injection.

"We look forward to further results from the SUSTAIN clinical development programme."

More data will be needed to convince regulators and doctors of its efficacy, however, as these data only show how well it works against placebo. 

The real test will be how the medicine performs in late-stage trials against direct competitors, including Victoza and other type II medicines from AstraZeneca and Merck & Co. 

Novo Nordisk said in a statement that it expects to announce headline results of the five remaining SUSTAIN trials “within the next nine months”.

Article by
Ben Adams

13th July 2015

From: Research

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