ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402

Decision taken to advance novel, long-acting anticoagulant into Phase II clinical development


BioInvent International AB and co-development partner ThromboGenics NV announced that they have successfully completed enrollment and initial follow-up of all volunteers in the first Phase I trial of TB-402, which is being developed for the prevention of venous thromboembolic disorders (VTE - blood clots).

TB-402 is a recombinant human monoclonal antibody that targets factor VIII, a component of the coagulation cascade. This antibody is a promising novel anticoagulant agent particularly because it only partially inhibits factor VIII activity even when administrated in very high doses. This may potentially decrease the risk of undesirable bleedings and the need for monitoring, which are the main concerns associated with anticoagulants currently on the market.

The trial, performed in Denmark, was a randomized, single-dose, placebo-controlled, dose-escalation trial in healthy male volunteers. 56 volunteers were enrolled into the trial, including both younger age volunteers (18-45) and older age volunteers (55-76).

Preliminary results of the trial showed that TB-402 met both the primary (safety and tolerability) and secondary (pharmacokinetic and pharmacodynamic) endpoints. The drug was well tolerated and the study showed that TB-402's prolonged half-life will allow for single-dose treatment in orthopaedic surgery patients and/or once a month administration for long-term stroke prevention in atrial fibrillation (AF) as opposed to daily treatment with current anticoagulants. Importantly, the findings confirm that TB-402 achieves only partial inhibition of FVIII activity without the undesired effect of total factor VIII inactivation. Final data analysis of the first Phase I trial will be available later this year.

Based on these results, and after review of preliminary results with the Scientific Advisory Board for this program, the Joint Steering Committee of BioInvent and ThromboGenics has decided to move TB-402 into Phase II clinical development. As part of the development programme, drug interaction studies will be performed in parallel with the preparation for Phase II, which is expected to start in H1 2008. The initial Phase II trial will be a dose-ranging clinical trial evaluating safety and efficacy (ability to prevent deep vein thrombosis - DVT) in an orthopaedic surgery setting.

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