TB-402 Phase II trial data was presented at the 21st International Congress on Thrombosis (ICT) in Milan, Italy by Peter Verhamme of University of Leuven, Belgium, in a presentation entitled, ‘Single intravenous administration of TB-402 for the prophylaxis of VTE after total knee replacement surgery.’
The Phase II results demonstrated superior antithrombotic activity of TB-402, when compared to enoxaparin. In the study both the drugs showed comparable safety.
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.
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.
Svein Mathisen, CEO of BioInvent, said: “We are excited by the opportunity that TB-402 provides in the anticoagulation marketplace due to its attractive dosing opportunities and half life and the benefits this will provide for patients and healthcare providers alike.”
Patrik De Haes, CEO of ThromboGenics, said: “We are very pleased by Professor Verhamme’s presentation of the exciting TB-402 Phase II data at this conference. We are encouraged that TB-402 has demonstrated an attractive profile compared to the current gold standard.”