Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS-FXI Rx for the Prevention of Venous Thrombosis in Patients Undergoing Total Knee Replacement Surgery
"Thrombosis is the leading cause of morbidity and mortality worldwide. Although warfarin and oral Factor Xa and thrombin inhibitors are effective, they have limitations that restrict or prevent their use in several indications. Furthermore, despite the benefit of existing anticoagulants, there is a risk of bleeding when they are administered in therapeutic doses. Consequently, there remains a significant unmet need for safer and more effective anticoagulants," said
In the paper and presentation titled 'Factor XI Antisense Oligonucleotide for Prevention of Venous Thrombosis' the authors report that ISIS-FXIRx-treated patients experienced a dose-dependent decrease in venous thromboembolic events. Patients treated with 300 mg of ISIS-FXIRx experienced a seven-fold lower rate of VTE as compared with those treated with enoxaparin (4.2% and 30.4%, respectively; p<0.001). Patients treated with 200 mg of ISIS-FXIRx had a rate of VTE comparable to that in patients treated with enoxaparin (26.9% and 30.4%, respectively). The rate of VTE in patients given enoxaparin is within the range documented in previous studies in this therapeutic setting. ISIS-FXIRx treatment was associated with a dose-dependent and sustained reduction in Factor XI activity that correlated with the lower rate of VTE. The rate of bleeding was low with ISIS-FXIRx and enoxaparin.
"This study is the first to evaluate a Factor XI lowering therapeutic strategy in patients and the results validate Factor XI as a novel target for antithrombotic therapy. These data show that ISIS-FXIRx significantly lowered the risk of venous thromboembolism following a highly thromboembolic event, elective knee replacement surgery. The rate of VTE with ISIS-FXIRx in this Phase 2 study is lower than that observed in the previous studies with the new oral anticoagulants in this surgical setting. These data suggest that ISIS-FXIRx has the potential to be a best-in-class antithrombotic drug and could be useful in many different therapeutic settings, including patients at high-risk for thrombosis and high risk of bleeding" said
"TKA is associated with a high incidence of postoperative VTE. By evaluating our drug in this therapeutic setting, we were able to directly compare ISIS-FXIRx with enoxaparin, a commonly prescribed anticoagulant. In this study, the lower incidence of thromboembolic events with ISIS-FXIRx compared with enoxaparin, combined with the low rate of bleeding, support the concept that ISIS-FXIRx has the potential to provide a breakthrough therapeutic opportunity for the treatment of thrombosis. By reducing Factor XI activity, we believe that ISIS-FXIRx could be used to prevent thrombosis in many different therapeutic settings" said
"Our plan is to bring in a partner for later-stage development and commercialization of this program. We have already had considerable interest from potential partners," said
The Phase 2 study of ISIS-FXIRx in 293 patients undergoing TKA was a global, multi-center, open-label, comparator-controlled study comparing ISIS-FXIRx with enoxaparin. Patients in the ISIS-FXIRx-treated groups received either 200 mg or 300 mg of ISIS-FXIRx for six weeks prior to TKA surgery and six hours and three days after surgery. Patients in the enoxaparin group received 40 mg of enoxaparin the evening before surgery, and once daily thereafter for at least eight days. All patients underwent mandatory bilateral venography to detect deep vein thrombosis. Venograms and suspected bleeding events were evaluated by a blinded independent adjudication committee.
In this study, ISIS-FXIRx was well tolerated. There were no observed differences in safety outcomes compared with enoxaparin. In particular, there were no flu-like symptoms, and injection site reactions were infrequent and mild. There have been no drug-related serious adverse events reported to date.
The Phase 2 study was published ahead of print and on-line in
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