Shares in Denmark’s Novo Nordisk have risen sharply this morning after the firm announced positive results from two late-stage trials of its new antidiabetic liraglitude.
Two 26-week studies, the second and third of five Phase III studies with liraglitude, involved 2,132 patients and investigated the effect of different doses of the drug in combination with a single oral antidiabetic drug. After a run-in period to reach the maximal dose of glimepiride, patients in the LEAD 1 study were randomised to placebo, rosiglitazone or liraglutide while patients in the LEAD 2 trial were randomised to placebo, glimepiride or liraglutide.
In the LEAD 1 study, liraglutide provided statistically significantly better glucose control than rosiglitazone and led to around 40% of patients reaching the American Diabetes Association goal of average blood glucose control (HbA1c) of 7% at study completion. However, among the patients that had previously been treated with only a single oral antidiabetic drug, liraglutide treatment led to more than 50% of patients reaching this goal.
In LEAD 2 study, liraglutide treatment led to an HbA1c improvement that was similar to that observed in the glimepiride-treated group and at the highest dose of liraglutide, more than 40% of patients achieved the HbA1c target of 7%. Among patients previously treated with a single oral antidiabetic drug, close to 65% of the patients on this dose reached the target. At the end of the LEAD studies, a weight difference of between 2-4 kg in favour of liraglutide was found when compared to rosiglitazone and glimepiride treatment, respectively.
The firm also noted that liraglutide, in combination with glimepiride or metformin, was well tolerated and he most frequently reported adverse event during liraglutide treatment was nausea at an absolute level of between 5%-20% when used in combination with glimepiride and metformin.
Mads Krogsgaard Thomsen, Novo’s chief science officer of Novo Nordisk, said the encouraging clinical results confirm the positive effect of liraglutide on blood glucose control, body weight and hypoglycaemia risk seen in previous studies and leave us confident that we are on track to submit for regulatory approval mid-2008." The firm expects to announce results from the remaining two LEAD studies during the second half of 2007 and the first quarter of 2008.
Given by once-daily injection, liraglutide is likely to be launched in 2009, when it may directly compete with the once-weekly formulation of Eli Lilly and Amylin's Byetta (exenatide). Novo has high hopes for the drug and investors were pleased with the results, pushing the share price up almost 3.4% at 10.15 this morning to 586 kroner ($107).