Company Update (NYSE:NVO): Novo Nordisk Announces Phase 3b Trial Results for Xultophy


Novo Nordisk (NYSE:NVO) announced new phase 3b trial (DUAL VII) results with Xultophy® (IDegLira). Xultophy®is a once-daily, single injection fixed combination of a long-acting basal insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide).1 The open-label trial investigated the efficacy and safety of Xultophy® compared with insulin glargine U100 in combination with insulin aspart at all main meals, after 26 weeks of treatment in 506 adults with type 2 diabetes.

The trial successfully achieved its objective by demonstrating that treatment with Xultophy® is non-inferior to insulin glargine U100 in combination with insulin aspart with regards to lowering of HbA1c. From a mean baseline HbA1c of 8.2%, both patient groups reached a similar HbA1clevel of 6.7% after 26 weeks of treatment. At the end of the trial, people treated with Xultophy® required 40.1 units compared to a total of 84.6 units of insulin for people treated with insulin glargine U100 in combination with insulin aspart.

People treated with Xultophy® showed a superior reduction of 89% in the rate of severe or blood glucose confirmed symptomatic hypoglycaemic episodes compared to insulin glargine U100 in combination with insulin aspart. Furthermore, from a mean baseline body weight of 87.7 kg, people treated with Xultophy® experienced weight loss of 0.9 kg compared with weight gain of 2.6 kg for people treated with the basal-bolus regimen; a superior weight difference of -3.6 kg.

“We are excited about the results of DUAL VII, showing the important benefits Xultophy® offers for people inadequately controlled on insulin glargine U100 as an alternative to intensification with basal-bolus therapy” said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk A/S. “Xultophy® shows these impressive results, including reduction in hypoglycaemia and body weight, with a much lower dose compared to insulin glargine U100 in combination with insulin aspart at the end of the study.”

The safety profile of Xultophy® in DUAL VII was generally consistent with previous Xultophy® clinical trials.

The complete trial results will be presented in the first half of 2017. (Original Source)

Shares of Novo Nordisk closed yesterday at $33.55, down $0.05 or -0.15%. NVO has a 1-year high of $59 and a 1-year low of $30.89. The stock’s 50-day moving average is $40.13 and its 200-day moving average is $49.60.

On the ratings front, NVO stock has been the subject of a number of recent research reports. In a report issued on November 29, Credit Suisse analyst Rebekah Harper reiterated a Hold rating on NVO. Separately, on November 11, Jefferies’ Jeffrey Holford reiterated a Hold rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Rebekah Harper and Jeffrey Holford have a yearly average loss of 11.3% and a return of 1.1% respectively. Harper has a success rate of 0% and is ranked #3103 out of 4239 analysts, while Holford has a success rate of 40% and is ranked #1752.

Novo Nordisk AS engages in the research, development, manufacture, and marketing of pharmaceutical products. It operates through the Diabetes and Obesity Care, and Biopharmaceuticals segments. The Diabetes and Obesity Care segment covers insulins, glucagon-like-peptide 1, other protein-related products, oral anti-diabetic drugs and obesity. The Biopharmaceuticals segment involves in the research, development, manufacture, and distribution of products within the areas of haemophilia, growth hormone, hormone replacement, inflammation, and therapy areas.