OCEANIC
Studies show that 1 in 3 patients with atrial fibrillation are undertreated or untreated with oral anticoagulants, leading to a substantial unmet need for an effective therapy that does not further increase the risk of bleeding during treatment. Elderly patients with AF at high risk for bleeding and patients with AF and end-stage kidney disease (ESKD) on hemodialysis are often treated with a lower dose than recommended by guidelines. Further, those who discontinue OACs are at increased risk of experiencing a subsequent ischemic stroke. Inhibiting FXIa with asundexian might be able to tackle this unmet need, as it could provide protection from thrombotic events without a corresponding increase in bleeding risk.
'The promising clinical results we have seen so far indicate that asundexian could mark a new option for antithrombotic treatment for a broader range of patients', said Dr.
'For physicians, there are challenging clinical decisions we have to make when considering treatment options for atrial fibrillation patients who are at high bleeding risk, and not suitable for currently available oral anticoagulants', said Dr.
OCEANIC-
Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor for prevention of thromboembolic events, reducing pathological clot formation while allowing hemostasis to form clots to stop the bleeding.
About the OCEANIC Program
The OCEANIC clinical trial program is designed to evaluate the use of asundexian, as an oral FXIa inhibitor, in patients with atrial fibrillation (AF) at risk of stroke and in patients following acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), aiming to improve the benefit-risk profile when compared to standard of care. The program started with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, and is one of the largest clinical trial programs Bayer has undertaken, expecting to enroll nearly 30,000 patients in over 40 countries.
The
About OCEANIC-AF, OCEANIC-STROKE and OCEANIC-AFINA
OCEANIC-AF is a multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm Phase III study investigating asundexian compared to apixaban (a non-vitamin K antagonist oral anticoagulant) in patients with atrial fibrillation at risk for stroke to determine the safety and efficacy of asundexian on prevention of stroke and systemic embolism.
OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven Phase III study investigating the efficacy and safety of asundexian for prevention of ischemic stroke compared to placebo on top of standard-of-care antiplatelet therapy in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) / mini-stroke.
OCEANIC-
About FXIa inhibitors and Asundexian
Factor XI is a protein in the blood which is converted into its active enzyme form (Factor XIa) as part of the blood coagulation cascade. FXIa inhibition specifically targets the FXIa protein involved in pathological thrombus formation, while leaving hemostasis intact. Asundexian, as an oral direct, potent inhibitor of activated coagulation factor XI (FXIa), acts selectively on the coagulation cascade, thereby offering the potential to prevent events like stroke without a corresponding increase in bleeding risk associated with the current standard of care (SoC). Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention and could represent a new approach in antithrombotic treatment. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.
About Atrial Fibrillation
AF is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty completely, and blood does not flow properly, causing blood clots to form. These blood clots can break loose and travel to the brain, resulting in a stroke.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Contact:
Anne Jorgal
Email: anne.jorgal@bayer.com
Tel: +49 30 2215-41592
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