ThromboGenics and BioInvent Announce Positive Topline Results from Phase II VTE Prophylaxis Study with Anti-Factor VIII (TB-402)
TB-402 demonstrates superior antithrombotic activity to enoxaparin
Leuven, Belgium and Lund, Sweden – 6 May, 2010 – ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce today positive results from their Phase II trial of TB-402. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery. The Phase II results demonstrate that TB-402 has superior antithrombotic activity to enoxaparin (Lovenox®: sanofi-aventis) with comparable safety. Enoxaparin is currently the standard treatment to prevent VTE in this setting. Venous thromboembolism encompasses both deep venous thrombosis (DVT) and pulmonary embolism (PE).
The Phase II trial was a multicenter, dose-escalating, randomised, open-label trial, evaluating TB-402 against enoxaparin for the prophylaxis of VTE after knee surgery. All patients received enoxaparin 40mg pre-operatively. Post operatively, patients were randomized in a sequential cohort design to one of three doses of TB-402 (0.3mg/kg, 0.6mg/kg or 1.2mg/kg) or enoxaparin 40mg (3:1; n=75 per group).
TB-402 was administered as a single intravenous bolus injection 18–24 hours after orthopaedic surgery, whereas enoxaparin was given as a 40mg subcutaneous injection once daily for a period of at least 10 days. The primary efficacy endpoint was based on measuring all occurrences of VTE in patients by Day 7-11, whether they were symptomatic or asymptomatic. The primary safety endpoint was the number of patients with major or clinically relevant non-major bleeding from randomisation until the end of the study at 3 months. The study enrolled a total of 316 patients across 30 centers in Europe.
For the pooled TB-402 treated group, 47 out of 218 (or 22%) patients experienced VTE; for the enoxaparin treated group, 30 out of 77 (or 39%) patients experienced VTE (p<0.05). The difference of reduction between the two groups is statistically significant.The study also showed that TB-402 and enoxaparin had a similar safety profile.
The results of this trial (“Single intravenous administration of TB-402 for the prophylaxis of VTE after total knee replacement surgery”) will be presented by Prof. Peter Verhamme (University of Leuven, Belgium) at the 21st International Congress on Thrombosis in July in Milan, Italy.
Patrik De Haes, CEO of ThromboGenics, commented, “It is very clear that VTE is a major clinical problem that carries considerable costs both to patients and healthcare providers. These exciting results show that TB-402 when given as a single post-operative injection could dramatically reduce the incidence of VTE. This would clearly be a major step forward in preventing this potentially life threatening condition. These results also reinforce our confidence that we can secure a significant partnership deal that will allow us to bring TB-402 to market and deliver its significant potential.”
Svein Mathisen, CEO of BioInvent, also commented, “We are delighted with the progress of TB-402 and are excited about the product’s demonstrated success over current treatments in preventing VTE in post-operative patients and the associated advantages of this being delivered as a single dose. These results underpin our belief that this novel approach will find a solid place in the anticoagulation market.“
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TB-402 has the potential to be a very important new entrant into the anticoagulant market. TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulant therapy. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose to prevent the development of DVT in patients undergoing surgery. This simple approach to prophylaxis would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.
About Deep Vein Thrombosis (DVT)
DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg. DVT is a major public health issue and it is estimated that in the U.S. alone, more than 600,000 patients are treated for venous thromboembolisms (VTE) such as DVT or pulmonary embolism (PE) each year (1). Moreover, DVT and PE together may be responsible for more than 100,000 deaths in the U.S. each year.(2)
It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the U.S. if current trends persist (3). Patients undergoing hip replacement or knee surgery are particularly at risk of developing DVT and all patients are therefore treated with anticoagulants prophylactically in order to reduce the risks of blood clots. The annual sales of anticoagulants worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with an increased risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a significant unmet need.
1) Barclays Capital Equity Research Report on New Anticoagulants, August 5, 2009
2) “The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism,” September 15, 2008, p.1.
3) “Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004,” Sunny Kim, Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.
For further information, please contact:
Patrik De Haes, MD Andy De Deene, MD
Chief Executive Officer Clinical Director Europe
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Citigate Dewe Rogerson
Amber Bielecka, David Dible, Nina Enegren
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BioInvent International AB
Svein Mathisen Cristina Glad
President & CEO Executive Vice President
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