AMAG Announces Presentation of Ciraparantag Data at the International Society on Thrombosis and Haemostasis - Seite 2

“DOACs have become the dominant means for chronic anticoagulation, and there remains a need for an effective reversal agent with broad activity that can be administered quickly and conveniently for patients with serious uncontrolled bleeding or those who require emergency surgery,” said Dr. Jack Ansell, Professor of Medicine, Hofstra Northwell School of Medicine. “These data are encouraging as they demonstrate a ciraparantag dose response for reversal of apixaban and rivaroxaban which, along with the safety findings, will inform dose selection for future studies.”

In the two studies, adult subjects were treated with apixaban or rivaroxaban and those who reached steady-state anticoagulation were randomized within each dose cohort in a 3:1 ratio to receive ciraparantag or placebo, which was administered three or four hours after last dose of the anticoagulant. Ciraparantag was administered as a single intravenous infusion over 10 minutes, followed by serial testing of WBCT over 24 hours. Doses of ciraparantag were evaluated at 30 mg, 60 mg and 120 mg for apixaban and 30 mg, 60 mg, 120 mg and 180 mg for rivaroxaban.

About Ciraparantag
Ciraparantag is a novel small, water-soluble molecule being investigated for reversal of anticoagulation induced by direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH). Target patient populations include patients for whom rapid reversal of anticoagulation is needed because of life-threatening or uncontrolled bleeding, or for emergency surgery or urgent procedures. It is believed that ciraparantag exerts its effects by binding to and blocking the effects of DOACs such as Xarelto (rivaroxaban), Eliquis (apixaban) and Savaysa (edoxaban), as well as to the LMWH Lovenox (enoxaparin sodium injection), which in turn reestablishes normal clot formation. Ciraparantag is administered by intravenous infusion; the anticipated clinical treatment regimen is a single dose administered over approximately 10 minutes. Ciraparantag has been studied across seven completed trials, with 277 subjects having been dosed with ciraparantag and has been well tolerated in these studies. To date, the most common adverse events related to ciraparantag have been mild transient sensations of warmth or skin flushing, skin tingling, and alterations in taste.