The drug, TB-402, is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood.
The study is a dose escalation trial in healthy volunteers, and the objective is to investigate safety, tolerability and pharmacokinetic properties of the candidate drug. It is expected that the results will be presented in late 2007.
Given a positive outcome of the initial phase I study, the parties plan to follow up with a phase IIa program in patients undergoing orthopedic surgery who are at risk for thrombosis. TB-402 is also expected to be developed as a potential treatment to prevent blood clot formation in connection with certain types of heart arrhythmia, such as atrial fibrillation.
TB-402 has shown a beneficial partial inhibition of Factor VIII, even when applied in excess dosage. Extensive testing in several animal models has shown that the antibody strongly reduces the risk of thrombosis without increasing the risk of bleeding.