Asundexian (FXIa inhibitor) lowers ISTH major and clinically relevant non-major bleeding rates compared to apixaban in patients with atrial fibrillation at risk for stroke, PACIFIC-AF study results
Both asundexian 20mg and 50mg doses showed almost complete FXIa inhibition and significantly lower bleeding rate and tolerability compared to apixaban
Bayer recently developed asundexian, an oral factor XIa, FXIa inhibitor, and apixaban (non-vitamin-K oral anticoagulant, Non-Vitamin K Antagonist Oral) for patients with atrial fibrillation. We published positive data from the PACIFIC-AF clinical trial, a comparative study of the safety profile of anticoagulant (NOAC).
In the PACIFIC-AF clinical study, the bleeding rate for the key endpoint (ISTH major or clinically relevant non-major bleeding) was 67% (incidence proportion) to 0.33). The once-daily therapy that selectively modulates blood clotting The FXIa inhibitor Asundexian is being investigated as a new treatment option for the prevention of thrombosis. The results of this study were presented at this year’s annual meeting of the American Heart Association (ACC. 22) and were simultaneously published in ‘The Lancet’.
“There is an unmet need for stroke prevention in patients with atrial fibrillation,” said Manesh Patel and Professor Richard S. Stack, director of cardiology at Duke University and co-director of the Cardiac Center. Despite guidelines recommending oral anticoagulant treatment in patients, approximately 40% of AF patients receive insufficient or no treatment at doses lower than recommended Patients are vulnerable to life-threatening thromboembolism such as stroke It can be done,” he said. He continued, “The data from PACIFIC-AF show that asundexian achieved significantly less bleeding and near complete inhibition of FXIa compared to apixaban in stroke-risk patients with atrial fibrillation. Once the licensing study begins, patient treatment It will be a very welcome development in the future.”
PACIFIC-AF is the first direct comparative clinical trial comparing the bleeding risk of oral FXIa inhibitors and NOACs in patients with atrial fibrillation at risk for stroke. The primary purpose of this study was to determine whether the incidence of major or clinically relevant non-major bleeding was reduced by treatment with asundexian compared to apixaban in patients with atrial fibrillation. The goal was to determine the optimal dose of This clinical trial is not intended to determine or test differences in the incidence of thrombotic events.
“The results of this clinical study further support the mechanism of asundexian and its safety profile in patients with atrial fibrillation,” said Christian Rommel, Executive Director and Head of R&D, Bayer Pharmaceutical Business Unit. ) through our inhibitor program, we are developing innovative next-generation therapies for patients and families affected by cardiovascular disease.”
About Asundexian and FXIa Inhibitors
Asundexian (BAY243334) specifically targets proteins involved in pathological thrombus formation, but has the potential to prevent thromboembolism without increasing bleeding risk by maintaining pathways involved in physiological vascular therapy. This mechanism of action could be a new treatment option in the prevention of thrombosis. The PACIFIC clinical program was designed to test the hypothesis that FXIa inhibition with asundexian could reduce the risk of thrombotic events, such as stroke and myocardial infarction, without an increased risk of bleeding. Asundexian is an oral drug administered once a day and has not been approved in any country in the world.
About the PACIFIC-AF Clinical Trial PACIFIC-AF is a randomized, double-blind, phase 2 dose study, asundexian 1 in male or ≥3 female patients with atrial fibrillation with a CHA2DS2-VASc score ≥2 or CHA2DS2-VASc ≥ 45 years of age at high bleeding risk. Administration of 20 mg or 50 mg once a day was compared with administration of apixaban twice a day. The primary endpoint was the pooled variable of major or clinically relevant non-major bleeding. 755 patients participated in this clinical trial, with an average age of 73.7 years. Asundexian 20 mg and 50 mg inhibited FXIa activity by 81-90% and 92-94%, respectively, at the lowest and highest concentrations. Asundexian almost completely inhibited FXIa in vivo at both doses and had a significantly lower bleeding rate compared to apixaban (cumulative incidence proportion of 0.33 combined dose).
About atrial fibrillation
Atrial fibrillation is the most common type of arrhythmia. In atrial fibrillation, the upper chamber (atrium) of the heart contracts irregularly. These clots can travel to the brain and cause a stroke.
About Bayer
Bayer is a global company with core competencies in healthcare and agriculture, the life science fields. Bayer’s products and services aim to improve the quality of life and quality of human life by contributing to finding solutions to the major challenges of today’s era due to the growing global population and aging population. Bayer aims to maximize profits and create value through innovation and growth under the principle of sustainable growth, and the Bayer brand symbolizes trust, trust and excellence worldwide. As of fiscal year 2021, it employs approximately 100,000 employees, generates sales of 44.1 billion euros and R&D investments of 5.3 billion euros. For more information, visit www.bayer.com.
References
1 A 67% reduction in bleeding rate corresponds to a cumulative incidence of 0.33 when comparing the asundexian integrated dose to apixaban.