Novo Nordisk and Neose Technologies, Inc. have announced the completion of the initial  phase I clinical trial for NN7128 (GlycoPEGylated factor VIIa), a longer-acting version of NovoSeven®, Novo Nordisk’s existing recombinant factor VIIa (rfVIIa) product. NN7128 is being developed under a license agreement with Neose, a clinical-stage biopharmaceutical company based in Horsham, PA.

To extend the half-life of the new drug, Novo Nordisk’s (rfVIIa) protein is attached with polyethylene glycol (PEG). The process, known as pegylation, prolongs the drug’s presence in the body. Neose’s proprietary GlycoPEGylation technology serves this purpose. The goal of the trial was to measure the pharmacokinetics and safety of NN7128 in 30 healthy subjects. The companies reported that a “significant” prolongation of the drug’s half-life was noted, and that single doses of NN7128 were well tolerated. 

“We are pleased to report the successful completion of this Phase 1 study and to have demonstrated a prolonged half-life of NN7128,” said Soren Bjorn, Corporate Vice President, Biopharm Research at Novo Nordisk. “As we continue our analysis of the data collected in this study, we look forward to presenting the full results at upcoming scientific and medical meetings.”

NovoSeven® is approved by the U.S. Food and Drug Administration to treat bleeding episodes and prevent bleeding during surgery or other invasive procedures, in people with hemophilia A or B who have developed inhibitors to FVIII or FIX. It is also approved in patients with inherited FVII deficiency, to treat bleeding episodes and for use during surgery or other invasive procedures.

Source: Novo Nordisk press release dated June 2, 2008