Summarizes ciraparantag’s expected mechanism of action, pharmacokinetic, and pharmacodynamic characteristics and its proof of concept as an anticoagulant reversal agent
LUXEMBOURG and ZUG, Switzerland, Nov. 19, 2020 /PRNewswire/ — Covis Group S.à r.l. (“Covis”) today announced that data demonstrating that the investigational anticoagulant reversal agent ciraparantag binds to unfractionated heparin, low molecular weight heparin (LMWH) and direct oral anticoagulants (DOACs) were published in Blood, the journal of the American Society of Hematology (ASH).
“These preclinical data demonstrate that ciraparantag has several key attributes including its ability to reverse the anticoagulant effect of apixaban, rivaroxaban, edoxaban, dabigatran, and LMWH,” said lead author Dr. Jack Ansell, Professor of Medicine, Hofstra Northwell School of Medicine. “These studies provided us with supportive evidence that formed the foundation of Phase 2a healthy volunteer trials and they suggest that ciraparantag could provide physicians with a rapid and easily administered treatment option.”
Studies using dynamic light scattering (DLS) methodology demonstrated that ciraparantag binds to unfractionated heparin, enoxaparin (a low molecular weight heparin), and many DOACs, and by doing so, prevents these anticoagulants from associating with their respective target coagulation factors (e.g., FXa), thereby allowing normal coagulation activity to be restored. DLS studies also tested ciraparantag against a panel of selected medications that may be used in this patient population and did not detect significant binding.
Studies using animal models of bleeding showed that a single IV dose of ciraparantag given at peak concentrations of the anticoagulant significantly reduced the amount of blood loss regardless of whether the bleeding injury occurred before or after ciraparantag dosing. Ciraparantag reduced bleeding in a dose-dependent manner and was consistent across the DOACs and LMWH studied. In one of these studies, ciraparantag’s reversal of anticoagulation was observed as early as 10 minutes after ciraparantag was administered, which is predictive of a rapid onset of action.
“These data support the continued development of ciraparantag to potentially address an urgent unmet medical need in patients requiring rapid reversal of anticoagulation,” said Michael Porter, CEO of Covis. “We look forward to initiating the Phase 2b studies in healthy volunteers later this year to further study this investigational treatment, while continuing to monitor COVID-19’s impact on clinical trials.”
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 a number 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 more than 270 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. The safety and efficacy of ciraparantag is under investigation through the ongoing clinical development program, and ciraparantag is not approved for use by the FDA or any other regulatory authority.
Covis is headquartered in Luxembourg with operations in Zug, Switzerland and is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at www.covispharma.com.
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