Shares of Isis Pharmaceuticals ($ISIS) surged 9% this morning as the Carlsbad, CA-based antisense drug developer posted positive outcomes for a head-to-head Phase II study comparing ISIS-FXIRx with Lovenox on thrombosis. The biotech says the top 300 mg dose of its therapy beat out the widely used anticoagulant, lowering the number of blood clots while reducing the number of bleeding incidents.
The patients recruited for the study underwent total knee replacement surgery. Isis' drug targets Factor XI, a coagulation factor that plays a key role in thrombosis.
"Patients treated with 300 mg of ISIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin," Isis announced.The 200 mg arm of ISIS-FXIRx, though, worked about as well as Lovenox (enoxaparin).
"Although warfarin and oral Factor Xa and thrombin inhibitors are effective, there are limitations that preclude their use in a number of indications. In addition, bleeding remains a concern because there are no specific antidotes for the new oral anticoagulants. As such, there remains a significant unmet need for safer and more effective anticoagulants," said Jeffrey Weitz, professor of medicine and biochemistry at McMaster University. "This study is the first to evaluate a Factor XI lowering strategy in humans and the results validate Factor XI as a novel target for effective antithrombotic therapy."
That outcome set up this program for an attractive collaboration deal. "Due to the potential breadth of use as an anticoagulant, we expect Isis will partner this program within the next year," Deutsche Bank analysts noted today, according to a report from Reuters.
"Genetic and preclinical studies clearly suggest that reducing Factor XI should be a more effective means of reducing thrombogenic events than reducing other coagulation factors, and could be associated with very low bleeding risk. In fact, in head-to-head comparisons in animal models, we have shown that inhibiting Factor XI was more effective and produced less bleeding than achieved with warfarin or Factor Xa inhibitors. The results from this Phase II study support this attractive profile," said Brett Monia, Ph.D., senior vice president, antisense drug discovery at Isis.
- here's the release
- here's the story from Reuters