Novo Nordisk has confirmed it will drop further development of the hemophilia therapy candidate vareptacog alfa, as a consequence of reports in August that some patients in a Phase IIIa trial had developed antibodies to the fast-acting recombinant factor VIIa analogue. The global adept 2 trial involved 72 hemophilia patients who had developed inhibitors to existing therapy, and was comparing treatment on demand using either vatreptacog alfa or NovoSeven®.
Data from the study showed that while both drugs stopped a high percentage of bleeding episodes, a few patients developed anti-drug antibodies to vatreptacog alfa, including one patient with a potentially neutralizing effect in one sample. A number of patients developed cross-binding antibodies to NovoSeven, and although none were inhibitory, the development of anti-drug antibodies hadn’t previously been reported in patients treated with NovoSeven, including patients with inhibitors to factor VIII and IX. The fact that vareptacog alfa therapy did in some cases lead to the development of anti-NovoSeven antibodies has thus prompted Novo Nordisk to discontinue developing the candidate.