The first two patient cohorts included in total 200 individuals and the recruitment for the second cohort was concluded in August. The decision to start recruitment of the third patient cohort follows a unanimous recommendation from the external board monitoring the efficacy and safety of the study.
The phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicentre, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of deep vein thrombosis after knee surgery. The study will assess three different doses of TB-402 given as a single intravenous injection post knee replacement surgery and the trial will enrol 300 patients. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. All the patients in the study will be monitored for a period of three months after surgery. TB-402 is developed in collaboration with ThromboGenics NV.
TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulants. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose after surgery to prevent the development of deep vein thrombosis. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.
