ThromboGenics NV and BioInvent International have begun enrolling patients in a Phase II trial of TB-402, a long-acting anticoagulant being developed for the prevention of deep vein thrombosis (DVT).
The companies agreed to move ahead with trials after the external efficacy and safety monitoring board gave unanimous approval to proceed using a higher dose of TB-402.
The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicentre, prospective, randomised, open label trial to evaluate TB-402 for the prophylaxis of DVT after knee surgery.
The study will assess the safety and efficacy of three escalating doses of TB-402, given as a single intravenous bolus injection post knee replacement surgery.
TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade to reduce the risk of undesirable bleeding events, and the need for patient monitoring.
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 DVT as opposed to all current anticoagulant treatment options, which require daily treatment for up to several weeks.
The study will enrol a total of 300 patients across 36 centres, mainly in Europe.