IONIS FXIRx

Published

dm+d

Unassigned

New Medicines

Venous thromboembolism (VTE) prevention; in total knee replacement surgery

Information

New molecular entity
Ionis Pharmaceuticals
Ionis Pharmaceuticals

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Feb 21Not listed in Bayer pipeline, and no no apparent development since PII completed in 2014 [11].
Oct 19Still listed as PII in Bayer pipeline, but no apparent development since PII completed in 2014 [10]

Category

antisense oligonucleotide that inhibits expression of Factor XI
20 January 2016Without thromboprophylaxis 1 in 3 (30% to 50%) patients undergoing hip or knee replacement develop asymptomatic DVT, with 1 in 30 (3.5%) suffering symptomatic VTE and 1 in 250 (0.4%) suffering a fatal PE [6].
Venous thromboembolism (VTE) prevention; in total knee replacement surgery
Subcutaneous

Trial or other data

01. May 14: Phase 2 study (n=300) compared safety and efficacy of ISIS-FXRx to enoxaparin. Patients received ISIS-FXRx 200mg or 300mg for 6 weeks prior to total knee replacement (TKR) and a dose 6hrs and 3 days afterwards. Patients in the enoxaparin cohort received 40mg the evening prior to TKR surgery, 6-8hrs post-surgery and daily for at least 8 days afterwards. Patients treated with 300 mg of ISIS-FXIRx experienced a seven-fold (p<0.0001) lower incidence of VTEs compared to patients treated with enoxaparin. Patients treated with 200 mg of ISIS-FXIRx had comparable incidence of VTEs compared to patients treated with enoxaparin. Patients treated with ISIS-FXIRx and enoxaparin experienced a very low rate of bleeding with ISIS-FXIRx-treated patients experiencing numerically fewer bleeding events compared to patients treated with enoxaparin. [1]
02. Dec 14: Data from PII study described below (n=293) published on-line in the NEJM. The rate of VTE in pts treated with 300 mg of ISIS-FXIRx vs. enoxaparin was 4.2% and 30.4%, (p<0.001). The rate of VTE in pts treated with 200 mg of ISIS-FXIRx vs. enoxaparin was comparable (26.9% and 30.4%, respectively). Both were well tolerated [2,3].