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news.ThromboGenics and its co-development partner BioInvent International have released positive results from TB-402 Phase II trial.
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TB-402 is a new, 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.
In the trial, all patients received Enoxaparin 40mg pre-operatively. Post operatively, patients were randomised 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, 22% patients experienced VTE; for the Enoxaparin treated group, 39% patients experienced VTE. 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.
Patrik De Haes, CEO of ThromboGenics, said: “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, said: “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.”