BioInvent International AB (OMXS:BINV) and ThromboGenics NV (Euronext Brussels:THR) announce today positive results from their Phase II trial of TB-402. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery. The Phase II results demonstrate that TB-402 has superior antithrombotic activity to enoxaparin (Lovenox®: sanofi-aventis) with comparable safety. Enoxaparin is currently the standard treatment to prevent VTE in this setting. Venous thromboembolism encompasses both deep venous thrombosis (DVT) and pulmonary embolism (PE).
The Phase II trial was a multicenter, dose-escalating, randomised, open-label trial, evaluating TB-402 against enoxaparin for the prophylaxis of VTE after knee surgery. All patients received enoxaparin 40 mg pre-operatively. Post operatively, patients were randomized in a sequential cohort design to one of three doses of TB-402 (0.3 mg/kg, 0.6 mg/kg or 1.2 mg/kg) or enoxaparin 40 mg (3:1; n=75 per group).
TB-402 was administered as a single intravenous bolus injection 18