Biotech Values

[DewDiligence]

TB-402 (unsurprisingly) bombs in head-to-head vs Xarelto; program terminated:

http://www.marketwatch.com/story/thrombogenics-and-bioinvent-announce-results-from-phase-iib-venous-thromboembolism-prevention-study-with-tb-402-2012-06-05

ThromboGenics NV (euronext brussels:THR) and co-development partner BioInvent International (omxs:BINV) announce today the results from a Phase IIb trial comparing TB-402, a long acting anticoagulant, against rivaroxaban (Xarelto), an oral anticoagulant. The study showed that the incidence of venous thromboembolism (VTE) was similar with both drugs, but patients receiving TB-402 had a significantly higher incidence of bleeding events. Based on these results, ThromboGenics and BioInvent have decided to stop further development of TB-402.

I questioned the viability of the TB-402 program three years ago in #msg-35794827, mostly because of the unorthodox MoA; from that post:

I’m skeptical of this anticoagulation program for two reasons: the unorthodox MoA—inhibiting FVIII—and the slowness of the clinical progress to date. (The drug finished phase-1 eighteen months ago.) Inhibiting FVIII is a normal place to intervene in the coagulation cascade for a coagulant but it is not a normal place to intervene for an anticoagulant. The MoA of inhibiting FVIII is tantamount to inducing a mild, artificial state of hemophilia-A while hoping to avert the major-bleeding events typical of more severe manifestations of the disorder.

The idea didn’t work, evidently.