Bagsværd, Denmark, 19 March 2014 - Novo Nordisk today announced the completion of pathfinder(TM)2, the first phase 3 trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for haemophilia A patients. Pathfinder(TM)2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in patients with haemophilia A, who are 12 years or older.
In the trial, 175 patients were treated with a prophylactic regimen of 50 U/kg every fourth day and 11 patients received on-demand treatment, when bleedings occurred. Patients were treated for up to 21 months, resulting in median annualised bleeding rates of 1.3 and 30.9 episodes for patients treated prophylactically and on-demand, respectively.
The pharmacokinetic data documented a single dose half-life of 18.4 hours and a mean trough level of 8% measured immediately before next dose for patients on prophylaxis treatment.
N8-GP appeared to have a safe profile and to be well tolerated. Among the 186 patients in the trial, one patient who responded well to prophylactic treatment throughout the trial developed an FVIII inhibitor. This is in line with expectations in a population of previously treated haemophilia A patients.
"We are very pleased with the results of pathfinderT2. These results show that N8-GP has the potential to reduce the burden of treatment by decreasing the number of intravenous infusions while achieving strong results in terms of efficacy and safety for people with haemophilia A", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Novo Nordisk is expecting the three remaining trials in the pathfinderT programme to be finalised within the next 12 months. These trials investigate N8-GP as a treatment for paediatric patients, surgical procedures and as once-weekly prophylactic treatment.
About N8-GP and pathfinderT
N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life. The modification that renders N8-GP long-acting is located in the B-domain whereby the active factor VIII generated by thrombin activation is identical to endogenous FVIII and to activated turoctocog alfa.
PathfinderT is a Novo Nordisk registered trademark for trials conducted with N8-GP. The programme includes more than 200 patients with haemophilia A investigating pharmacokinetics, safety and efficacy of N8-GP in adults and children as well as patients undergoing surgery.
For further information
|Katrine Sperling||+45 3079 6718||[email protected]|
|Ken Inchausti (US)||+1 609 514 8316||[email protected]|
|Kasper Roseeuw Poulsen||+45 3079 4303||[email protected]|
|Frank Daniel Mersebach||+45 3079 0604||[email protected]|
|Lars Borup Jacobsen||+45 3075 3479||[email protected]|
|Daniel Bohsen||+45 3079 6376||[email protected]|
|Jannick Lindegaard (US)||+1 609 786 4575||[email protected]|
Company announcement No 16 / 2014