New data in the European Heart Journal show ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in elderly patients
Zug, Switzerland, October 4, 2021 – Covis Pharma GmbH (“Covis”) and Norgine B.V. (“Norgine”) today announced data demonstrating the investigational anticoagulant reversal agent, ciraparantag, reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly patients, were published in the European Heart Journal, official journal of the European Society of Cardiology.
“This Phase 2a study demonstrates that ciraparantag rapidly and effectively reverses the anticoagulant activity of the most commonly used direct oral anticoagulants, apixaban and rivaroxaban,” said lead author Dr. Jack Ansell, professor of medicine, Hofstra Northwell School of Medicine. “The reversal was sustained and without important side effects suggesting that ciraparantag has the potential to fill an important gap in our ability to treat major bleeding, a not uncommon occurrence with these anticoagulants.”
Ciraparantag produced a rapid and dose-related reversal of anticoagulation induced by apixaban and rivaroxaban compared with placebo in two dose ranging studies in healthy elderly adults (age 50-75 years). Anticoagulation was completely reversed within 1-hour post-dose and was sustained through 5 hours (for apixaban) and 6 hours (for rivaroxaban). Ciraparantag provided a dose-related reversal of anticoagulation induced by steady-state dosing of apixaban or rivaroxaban.
In these two randomized, single-blind, placebo-controlled Phase 2 clinical trials, ciraparantag was well tolerated across the range of doses evaluated and shown to be safe. The most common adverse events were mild, transient sensations of warmth or flushing and were dose related.
“These data provide further support for the potential value that ciraparantag offers as a broad-spectrum, conveniently dosed, rapid-acting anticoagulant reversal agent,” said Raghav Chari, PhD, chief innovation officer of Covis. “We look forward to continuing the development of ciraparantag in the various studies we are planning.”
Christopher Bath, chief operating officer of Norgine, continued, “Our commitment to transforming patients’ lives drives everything we do at Norgine and we are delighted to be working with Covis to support the development of 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 a number of DOACs such as Xarelto® (rivaroxaban), Eliquis® (apixaban) and Lixiana / 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, with global operations in Zug, Switzerland, 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.
Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Norgine is proud to have helped 22 million patients around the world in 2020 and generated €448 million in net product sales, a growth of 7% over 2019. Additional information is available at www.norgine.com.
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