ThromboGenics and BioInvent Complete Enrolment of Phase IIb Trial with TB-402 Ahead of Schedule
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The treatment is for the prophylaxis of venous thromboembolism (VTE) after total hip surgery and the trial has recruited patients from 36 centers across Europe. It is anticipated that the swift inclusion of patients in the final recruitment phase of the study will allow the Companies to report the outcome in the second quarter of 2012. This is ahead of previous guidance, which was the second half of 2012.
This double blind, randomized controlled trial is comparing two doses of TB-402 (25mg and 50mg), given as a single intravenous infusion after total hip replacement, with the recently approved factor Xa inhibitor rivaroxaban, which is given orally (10mg) once a day for 35 days.
TB-402 is a recombinant human monoclonal antibody that has a novel mode of action. It partially inhibits factor VIII, a key component of the coagulation cascade. An important potential benefit of TB-402 is that a single injection provides safe, stable, long-term anticoagulation for approximately one month, depending on the dose. This is expected to lead to reduced nursing time and improved patient compliance.
In 2010, a 316-patient Phase IIa trial comparing TB-402 with enoxaparin for VTE prophylaxis after total knee replacement reported positive results. Patients treated with one of three doses of TB-402 had a significantly lower incidence of total VTE (22%) compared with patients treated with enoxaparin (39%). In this study, TB-402 was well tolerated and demonstrated comparable safety to enoxaparin.
