Novo Nordisk (NVO) announced positive data from a phase III study (pathfinder 2) on its hemophilia A candidate, N8-GP. The candidate is being evaluated for the prophylaxis and treatment of bleeds.
The multi-national pathfinder 2 study (n=186) evaluated the safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in hemophilia A patients (12 years or more).
For a period of 21 months, 175 patients were treated with a prophylactic regimen every fourth day while the remaining 11 patients received on-demand treatment once bleeding occurs. The median annualized bleeding rates were 1.3 for patients treated prophylactically and 30.9 for patients treated on-demand. N8-GP was generally safe and well tolerated
In the coming twelve months, Novo Nordisk expects the three remaining phase III studies in the pathfinder program to be completed. These three trials will evaluate N8-GP for the treatment for pediatric patients, surgical procedures and as a once-weekly prophylactic treatment.
Another hemophilia candidate in Novo Nordisk’s pipeline is N9-GP. The company announced positive data from a second phase III study (paradigm 3) on its hemophilia B candidate, N9-GP in Jan 2014. The company expects to file N9-GP for approval U.S. and EU in 2015.
Novo Nordisk carries a Zacks Rank #3 (Hold). The data from this study was encouraging. N8-GP has shown the potential to reduce the burden of treatment by decreasing the number of intravenous infusions along with strong efficacy and safety results. However, the hemophilia A market is crowded with drugs like Kogenate FS, Advate and Xyntha.