Ionis Reports P-IIb (RE-THINC ESRD) Study Results of Fesomersen for the Treatment of End-Stage Renal Disease on Hemodialysis
Shots:
- The P-IIb (RE-THINC ESRD) study evaluating the safety, PK & PD of multiple doses of fesomersen (40/80/120mg for ~48wks.) vs PBO in 307 patients with end-stage renal disease on hemodialysis. The study was conducted by Bayer
- The trial met its 1EPs & showed an improvement in incidence of major bleeding & clinically relevant non-major bleeding, and reductions in factor XI activity levels. The results were consistent with the clinical profile seen across other LICA program, was safe & well-tolerated
- In prior clinical studies, the results showed IONIS-FXIRx, dose-dependent inhibition of factor XI activity which was associated with reductions in clotting events with no increase in major bleeding events
Ref: PRNewswire | Image: Ionis
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