BioInvent and ThromboGenics Announce Positive Topline Results from Phase II VTE Prophylaxis Study with Anti TB-402
News May 06, 2010
BioInvent International AB and ThromboGenics NV announce 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, randomized, 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 18–24 hours after orthopaedic surgery, whereas enoxaparin was given as a 40 mg subcutaneous injection once daily for a period of at least 10 days. The primary efficacy endpoint was based on measuring all occurrences of VTE in patients by Day 7-11, whether they were symptomatic or asymptomatic.
The primary safety endpoint was the number of patients with major or clinically relevant non-major bleeding from randomization until the end of the study at 3 months. The study enrolled a total of 316 patients across 30 centers in Europe.
For the pooled TB-402 treated group, 47 out of 218 (or 22%) patients experienced VTE; for the enoxaparin treated group, 30 out of 77 (or 39%) patients experienced VTE (p<0.05). The difference of reduction between the two groups is statistically significant. The study also showed that TB-402 and enoxaparin had a similar safety profile.
The results of this trial (“Single intravenous administration of TB-402 for the prophylaxis of VTE after total knee replacement surgery”) will be presented by Prof. Peter Verhamme (University of Leuven, Belgium) at the 21st International Congress on Thrombosis on July 8 in Milan, Italy.