2022-11-07| Trials & Approvals

Ionis Pharmaceuticals’ Factor XI Reduction Proved Effective in Trial

by GeneOnline
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Southern California-based Ionis Pharmaceuticals announced topline results from the Phase 2b RE-THINC ESRD study. The clinical trial evaluated fesomersen (formerly IONIS-FXI-LRx) an antisense medicine under investigation. Fesomersen is intended for the reduction of the production of Factor XI in thrombosis cases. 

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Positive Results in the Reduction of Factor XI

Thrombosis is a condition wherein blood clots form inside arteries and veins. These clots result in the blockage of oxygen flow to tissues and organs. The clots can also break apart, with the fragments traveling throughout the body’s circulation to vital organs. As a result, thrombosis is the leading cause of morbidity and mortality with nearly 15.3 million deaths a year due to heart attacks and strokes.

Ionis’ solution is a drug known as fesomersen. The treatment works by reducing Factor XI, a protein responsible for coagulation of the blood. Ionis initiated the RE-THINC ESRD study for the evaluation of fesomersen in patients with end-stage renal disease (ESRD) on hemodialysis.

The study results, presented at presented by Bayer at the American Society of Nephrology’s (ASN) Kidney Week 2022, showed that fesomersen reduced Factor XI to levels of 53.1%, 72.2% and 86.6% in the 40 mg, 80 mg, and 120 mg doses of fesomersen. This proved that fesomersen met the phase 2b trial’s primary endpoint. 

On the results of the trial, Richard S. Geary, Ph.D., executive vice president and chief development officer at Ionis, said, “We are very pleased with the efficacy and safety data seen in the Phase 2b study of fesomersen in patients with ESRD, which we believe supports continued advancement of this potential novel anti-thrombotic therapy for patients with renal and cardiovascular diseases. We thank Bayer for their partnership in the development of fesomersen. We are focused on getting fesomersen into the hands of a new partner to deliver it to the market and patients in need.”

As a result of the trial, Ionis will likely move fesomersen into futher testing, likely in a Phase 3 trial. 


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