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Ionis announces positive topline results from Phase 2b clinical study of fesomersen, a potential novel anti-thrombotic treatment
Phase 2b RE-THINC ESRD study of fesomersen met its primary endpoint in patients with end-stage renal disease on hemodialysisFesomersen demonstrated
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"Phase 2b RE-THINC ESRD study of fesomersen met its primary endpoint in patients with end-stage renal disease on hemodialysisFesomersen demonstrated substantial and statistically significant reductions in Factor XI activity levelsFesomersen, a novel Factor XI antisense inhibitor designed to prevent thrombosis, was safe and well-tolerated in the study with up to 48-week treatmentCARLSBAD, Calif., July 28, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today announced positive topline results of the Phase 2b RE-THINC ESRD study of fesomersen, formerly IONIS-FXI-LRx, in patients with end-stage renal disease (ESRD) on hemodialysis. In the study, fesomersen achieved its primary outcome measure of no increase in incidence of major bleeding and clinically relevant non-major bleeding as compared to placebo. Data from the study show that fesomersen, administered monthly at 40 mg, 80 mg and 120 mg for up to 48 weeks, was safe and well-tolerated. Fesomersen also demonstrated substantial and statistically significant reductions in Factor XI activity levels.\n\n \n \n \n \n \n \n\n \nData from the study are consistent with the clinical profile seen across Ionis' other LICA programs, further validating how advancements in the company's LIgand-Conjugated Antisense technology position Ionis to deliver potentially transformative treatments for a range of unmet medical needs. The RE-THINC ESRD study was conducted by Bayer, which licensed fesomersen from Ionis. Data from the study will be presented at an upcoming medical meeting.\n\"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,\" said Sanjay Bhanot, M.D., Ph.D., senior vice president, chief medical officer and metabolic and liver franchise leader at Ionis. \"The results of the RE-THINC ESRD study demonstrate fesomersen's potential as a novel anti-thrombotic treatment for cardiovascular and renal disease patients.\"\nAn estimated 17.9 million people die from cardiovascular disease each year, representing 32% of all deaths worldwide.1 Of these deaths, 85% are due to heart attacks and strokes, which are often caused by blood clots (thrombosis) that block blood vessels in the heart or brain. Fesomersen is...