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news.BioInvent International and ThromboGenics have released the positive results from their Phase II trial of TB-402, a new, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery.
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BioInvent International and ThromboGenics said that the Phase II results demonstrate that TB-402 has superior antithrombotic activity to enoxaparin with comparable safety. Enoxaparin is currently the standard treatment to prevent VTE in this setting.
BioInvent International and ThromboGenics claimed that 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 40mg pre-operatively. Post operatively, patients were randomised in a sequential cohort design to one of three doses of TB-402 (0.3mg/kg, 0.6mg/kg or 1.2mg/kg) or enoxaparin 40mg.
In the trial, TB-402 was administered as a single intravenous bolus injection 18–24 hours after orthopaedic surgery, whereas enoxaparin was given as a 40mg 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 randomisation until the end of the study at 3 months.
Reportedly, 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 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’) are expected to be presented by Peter Verhamme (University of Leuven, Belgium) at the 21st International Congress on Thrombosis on July 8 in Milan, Italy.
Svein Mathisen, CEO of BioInvent, said: “We are delighted with the progress of TB-402. These results underpin our belief that this new approach will find a place in the anticoagulation market.”
Patrik De Haes, CEO of ThromboGenics, said: “It is very clear that VTE is a clinical problem that carries considerable costs both to patients and healthcare providers. These results show that TB-402 when given as a single post-operative injection could dramatically reduce the incidence of VTE.
” These results reinforce our confidence that we can secure a partnership deal that is expected to allow us to bring TB-402 to market.”