|Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen|
Novo Nordisk ($NVO) is touting the first Phase III success for its once-weekly GLP-1 therapy semaglutide. The Danish pharma company says that two doses of the drug--a key part of the pipeline--slashed HbA1c levels by 1.5% and 1.6%.
Starting off a baseline score of 8.1%, the cuts mean that most patients were able to land in the 6.5% to 7.0% sweet spot needed to maintain their health. Investigators added that 74% and 73% of the people treated with 0.5 mg and 1.0 mg semaglutide, respectively, achieved the ADA target level, compared with 25% of the people treated with placebo.
The study also delivered some significant weight loss scores for patients, another key measure of success. Starting with an average weight of 92 kg, patients in the semaglutide arm lost 3.8 kg (0.5-mg dose) and 4.6 kg (1.0-mg dose), respectively, compared with a weight loss of 1.0 kg for people treated with placebo.
The drug arms did have a higher dropout rate of 6% and 5%, with the placebo group only registering 1% as dropouts. The primary side effect was nausea, according to Novo, which also fits the same profile for Victoza.
"We are excited about these results, which confirm that semaglutide has the potential to help people with Type 2 diabetes achieve both good glycemic control and a significant weight loss with one weekly injection," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We look forward to further results from the SUSTAIN clinical development program."
The company's Victoza, a daily GLP-1 injection, currently leads the field with $2 billion in annual sales, and Novo won approval in 2014 for the obesity-treating Saxenda, a higher dose of the same active ingredient. Meanwhile, Eli Lilly ($LLY) is fast encroaching on Novo's GLP-1 territory, securing FDA approval last year for the once-weekly Trulicity, the only contender that has measured up to Victoza in a Phase III trial.
Novo also has an oral version of semaglutide in development, OG217SC, which recently scored a success in a Phase II trial. And there's a long road ahead for semaglutide, with 5 more Phase III hurdles ahead. In diabetes, regulators demand an abundance of safety and efficacy data ahead of an approval, and this is a game that Novo understands well.
- here's the release
Damian Garde contributed to this story.