TB-402
Product description
TB-402 is a humanised monoclonal antibody that targets
Factor VIII, a blood clotting factor. The product is being
developed as an anti-coagulant, to prevent deep vein thrombosis in
connection with orthopaedic surgery and to prevent stroke in
patients with atrial fibrillation.
Product rationale
TB-402 shows an advantageous partial inhibition of Factor
VIII, and the level of inhibition does not rise beyond a particular
point, regardless of the dose administered. This and other evidence
suggests that TB-402 could have a lower risk of overdose and fewer
side effects than currently available anti-coagulants. As a
consequence patients may require less monitoring.
In addition, TB-402 could be more convenient to administer than current treatments. Its long half life means that it could be given to patients less frequently than other anti-coagulants.
Clinical status
A Phase II proof of concept study was initiated in
February 2009. This will test TB-402 in patients undergoing knee
operations to examine whether the antibody can prevent thrombosis
after surgery.
Phase I studies with TB-402 have been completed. A randomised, placebo-controlled, dose-escalation study in 56 healthy male volunteers showed that the drug was safe and well-tolerated. No serious adverse events or bleeding complications were reported. In addition the drug showed anti-coagulant effects.
A further Phase I study showed that the activity of TB-402 can be reversed by administering recombinant Factor VIII. It also showed that the product did not interact with either warfarin or Low Molecular Weight Heparin, the most commonly prescribed anti-coagulants.
Preclinical studies in animal models demonstrated that TB-402 could inhibit thombosis without causing increased bleeding.
Development and commercialisation strategy
TB-402 is being developed in conjunction with
ThromboGenics Ltd.