Novo Nordisk's ($NVO) weekly diabetes treatment succeeded in a 5th Phase III trial, moving the Danish drugmaker one step closer to succeeding its blockbuster Victoza.
The injected treatment, semaglutide, is a weekly therapy that, like Victoza, is an analog of the hormone GLP-1 that boosts the body's natural production of insulin. In a trial on 397 patients with Type 2 diabetes, semaglutide significantly improved blood sugar control compared with placebo when both were added to standard insulin therapy.
The 0.5-mg dose of semaglutide reduced blood glucose by 1.4% from an average baseline of 8.4%, and the 1-mg dose resulted in a 1.8% drop, Novo said, each besting placebo's 0.1% reduction. Novo's treatment got the majority of patients below the American Diabetes Association's target blood glucose level of 7%, the company said, with 61% in the 0.5-mg group and 79% in the 1-mg cohort achieving their goals. Semaglutide also led to statistically significant weight loss and reduced patients' need for insulin, Novo said.
The latest success follows four positive Phase III trials pitting semaglutide against Merck's ($MRK) Januvia, AstraZeneca's ($AZN) Bydureon, Sanofi's ($SNY) Lantus and placebo. Novo is now working through a 6th trial involving more than 3,000 diabetics to determine semaglutide's long-term effect on outcomes, expecting data in the first half of this year.
With semaglutide, Novo is looking to shake up the market for GLP-1 treatments, now dominated by its daily Victoza. Eli Lilly ($LLY) and GlaxoSmithKline ($GSK) have launched weekly treatments over the past two years, competing with Bydureon, but Novo believes semaglutide can potentially lead the space thanks to its established efficacy in patients with both early-onset and late-stage diabetes.
Meanwhile, Novo is working through Phase III development with a potentially game-changing oral version of semaglutide, recruiting nearly 2,000 patients in a study testing its tablet against Januvia with a primary endpoint of lowering blood glucose and secondary goals including weight loss.
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