- Ionis Pharmaceuticals Inc IONS announced results from the Phase 2b RE-THINC ESRD study of fesomersen to reduce the production of Factor XI (FXI) for the prevention of thrombosis.
- Ionis to regain rights to fesomersen from Bayer AG BAYRY.
- The RE-THINC ESRD study evaluated fesomersen in patients with end-stage renal disease (ESRD) on hemodialysis.
- In the study, fesomersen achieved its primary endpoint, demonstrating no increase in the incidence of the composite of major bleeding and clinically relevant non-major (CRNM) bleeding with 24 weeks of treatment.
- Related: There's 'Outsized' Risk-Reward For This Biotech, Morgan Stanley Says, Predicting Shares Could Grow More Than 30%.
- Fesomersen also achieved dose-dependent and sustained median reductions in steady-state FXI levels of 53.1%, 72.2%, and 86.6% in the 40 mg, 80 mg, and 120 mg doses of fesomersen, respectively, administered once every four weeks.
- Incidences of dialysis circuit clotting and AV-access thrombosis diminished significantly with decreasing FXI levels, both of which were exploratory efficacy endpoints.
- Fesomersen showed favorable safety and tolerability.
- Price Action: IONS shares are down 2.46% at $43.40 on the last check Friday.
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