New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anticoagulant treatment

OCEANIC AFINA is a Phase III study investigating asundexian as a potential treatment in patients ( greater than 65 years of age) with atrial fibrillation (AF) at high risk for stroke or systemic embolism who are deemed ineligible for oral anticoagulation (OAC) treatment due to an increased risk of bleeding.

OCEANIC-AFINA complements OCEANIC-AF, an ongoing Phase III study investigating the efficacy and safety of asundexian for the prevention of stroke or systemic embolism in people with AF at risk of stroke. Together, the results from OCEANIC-AFINA and OCEANIC-AF aim at providing robust evidence for the efficacy and safety of asundexian across a broad range of patients with AF, including those who are at high risk for both ischemic stroke or systemic embolism and major bleeding events.

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. Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "It is our vision to support patients with atrial fibrillation, including those, that up to now were deemed as not eligible for treatment with OACs. We aim to offer them a new therapy option to improve their quality of life by reducing the fear of potential increased bleeding and help physicians confidently prescribe antithrombotic treatment to protect their patients. With OCEANIC-AFINA we will evaluate asundexian in a vulnerable untreated patient population."

"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. Roxana Mehran, Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at Icahn School at Mount Sinai. "These patients are often overlooked and excluded from clinical trial, so it is gratifying to see Bayer’s announcement of this study."

OCEANIC-AFINA is a multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, 2-arm Phase III study comparing the use of asundexian with placebo in patients with atrial fibrillation (AF) (greater than 65 years of age) at high risk for stroke or systemic embolism who are deemed ineligible for OAC treatment.