Ionis Pharmaceuticals is conducting a Phase 2b trial of fesomersen, an investigational antisense drug designed to reduce the production of factor XI to prevent thrombosis in end-stage renal disease (ESRD) patients on hemodialysis. announced positive results.
The RE-THINC ESRD study was conducted by Bayer, which developed the drug in partnership with Ionis in 2015. However, both companies have now terminated the agreement and the rights and licenses granted to Bayer under the partnership have been returned to Ionis.
The trial met its primary endpoint, showing that 24 weeks of treatment did not increase the combined incidence of major and clinically significant non-major bleeding.
In this study, fesomersen at doses of 40 mg, 80 mg, and 120 mg administered once every 4 weeks reduced steady-state factor XI levels by 53.1%, 72.2%, and 86.6%, respectively, in a dose-dependent and sustained manner. A median decrease was shown.
The incidence of dialysis circuit clotting and arteriovenous access thrombosis also decreased significantly with decreasing factor XI levels, the company reported, both of which were exploratory efficacy endpoints.
Thrombosis occurs when a blood clot blocks a blood vessel, impeding blood flow and preventing adequate oxygen flow to tissues and organs.
Current antithrombotic therapy includes anticoagulants such as warfarin, factor Xa inhibitors, and thrombin inhibitors. Although these therapies have proven effective in reducing the risk of thrombosis, they target factors required for normal clotting and can put patients at significant risk of bleeding. There is, he reports Ionis.
Fesomersen is an investigational antisense drug designed by Ionis to reduce the production of factor XI, a clotting factor produced in the liver at high levels that may increase the risk of thrombosis.
Alternatively, individuals who are factor XI deficient have a lower incidence of thrombosis-related events and little or no increased risk of bleeding, making factor XI an attractive target for antithrombotic drugs.
Commenting on the positive results, Ionis Executive Vice President and Chief Development Officer Richard Geary said: Advances in this potential novel antithrombotic therapy for patients with renal and cardiovascular disease.
“We are grateful for Bayer’s partnership in the development of fesomersen. We are focused on getting fesomersen into the hands of new partners to reach markets and patients in need.”
