Enrollment complete in ThromboGenics, BioInvent TB-402 Phase IIb trial on VTE

Dec 17 2011

ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today that they have completed the enrollment of a 632-patient Phase IIb trial with their novel long-acting anticoagulant TB-402 (factor VIII inhibitor) for the prophylaxis of venous thromboembolism (VTE) after total hip surgery. 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.

Dr Patrik De Haes, CEO of ThromboGenics, commenting on the announcement said: "Completing enrollment, ahead of schedule, of this important Phase IIb study with TB-402 in patients after total hip replacement, is a key step in our development of this potentially improved prophylactic option for VTE. VTE remains a significant unmet need in many clinical settings despite the introduction of a number of new anticoagulants. We believe that a single dose of TB-402, with its consistent, stable and long-term anticoagulant effect could improve compliance and convenience for patients who have undergone surgery."  

Svein Mathisen, CEO of BioInvent, added: "At BioInvent we are proud to have maintained the excellent momentum of this Phase IIb study of TB-402, which is on track to be completed ahead of schedule. By measuring TB-402 against one of the newer agents in the anticoagulant market, we expect decisive information that will allow us to shape the future development of our drug. "

SOURCE ThromboGenics