Ionis Pharmaceuticals, Inc. IONS announced positive topline results of the Phase 2b clinical trial of fesomersen in patients with end-stage renal disease (ESRD) on hemodialysis.
The RE-THINC ESRD study is a Phase 2b clinical trial designed to evaluate the safety, pharmacokinetics and pharmacodynamics of multiple doses of fesomersen in 307 patients with end-stage renal disease on hemodialysis.
The data readout from the study showed that fesomersen, administered monthly at 40 mg, 80 mg and 120 mg for up to 48 weeks, was safe and well-tolerated, achieved its primary outcome measure of no increase in incidence of major bleeding.
Sanjay Bhanot, Senior vice president and Chief medical officer, said, “For decades, anticoagulants have been a therapeutic mainstay in the treatment and prevention of thrombosis. However, they can be associated with increased bleeding risk, which can lead to major, sometimes fatal, bleeding events. The results of the RE-THINC ESRD study demonstrate fesomersen's potential as a novel anti-thrombotic treatment for cardiovascular and renal disease patients."
Thrombosis is the formation of blood clots inside blood vessels. Blood clots can obstruct blood flow to prevent sufficient oxygen flow to tissues and organs.
Price Action : Ionis shares are trading down 1 percent at $38.16 on Thursday at the time of publication
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