December 04, 2002
AstraZeneca’s (NYSE: AZN) Exanta (ximelagatran) is in phase III clinical trials for the management of venous thromboembolism (VTE). BiotechTracker’s modeling shows that, whereas similar developmental compounds have a 55% probability of FDA approval, Exanta’s probability of approval approaches 70%.
Exanta was one of the direct thrombin inhibitors whose developmental success resurrected anticoagulation as a hot topic at least year’s American Society of Hematology (ASH) meeting. This year, three key platform presentations and several poster presentations feature Exanta data.
The 1,233-patient THRIVE III trial will be the focus of a presentation next Monday. 12 months of fixed-dose Exanta 24 mg twice daily was efficacious, well tolerated, and associated with low bleeding rates as VTE prophylaxis for at-risk patients who had received 6 months of standard, contemporary oral anticoagulation.
EXPRESS data will also be presented on Monday. The 2,764-patient investigation has revealed that, for at-risk recipients, preoperative initiation of subcutaneous melagatran (Exanta’s parent compound) followed by oral Exanta provided superior VTE prophylactic efficacy compared to Aventis’s (NYSE:
AVE) Lovenox (enoxaparin) in patients undergoing hip or knee replacement surgery.
Monday’s third platform presentation should cause quite a stir, and may provide the most compelling evidence of utility. A 2,301-patient study suggests that fixed dose Exanta 36 mg twice daily, initiated the day after knee replacement surgery, has a superior VTE prophylactic effect profile compared to warfarin. The superiority of the treatment effect profile features not only greater therapeutic efficacy but also no comparative increase in clinically relevant bleeding and, most importantly, no requirement for the inconvenient aspects of warfarin care that include routine coagulation monitoring and dose adjustment.
Poster presentations scattered throughout the conference include data regarding Exanta’s activity at thrombin and thrombin-related biological targets in a manner suitable for potential combination therapies. ASH abstracts are reassuring concerning Exanta’s pharmacokinetics and pharmacodynamics as well as expected progress in the SPORTIF III and V trials designed to evaluate prophylactic effects on stroke and VTE in patients with atrial fibrillation.
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