LEUVEN, Belgium and LUND, Sweden, September 7 /PRNewswire/ --
- Decision Taken to Advance Novel, Long-Acting Anticoagulant Into Phase II Clinical Development
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on vascular disease, and co-development partner, BioInvent International (Nordic Exchange: BINV), announce today 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 factor
VIII activity without the undesired effect of total factor VIII
inactivation. Final data analysis of the first Ph
|SOURCE ThromboGenics NV|
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