Therapy Areas: Cardiovascular
First Patients Enrolled in Global Phase III Studies for Investigational Oral FXIa Inhibitor Asundexian
10 February 2023 - - The first patients have been enrolled in the initial trials for its OCEANIC clinical trial program, designed to explore the use of asundexian (BAY2433334), an investigational oral Factor XIa inhibitor, in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, a temporary period of symptoms similar to those of a stroke, German healthcare company Bayer said.

Asundexian belongs to a potential new class of drugs being studied for thrombosis prevention.

OCEANIC is one of the largest Phase III endeavors Bayer has ever undertaken.

OCEANIC-AF (Oral faCtor Eleven A iNhibitor asundexIan as novel antithrombotic - Atrial Fibrillation study) is a multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, two-arm study that will investigate asundexian compared to apixaban in patients with atrial fibrillation at risk for stroke.

The primary objectives of OCEANIC-AF are to determine the effects of asundexian on prevention of stroke and systemic embolism as well as compare the incidence of International Society on Thrombosis and Hemostatis major bleeding.

Its first patient was enrolled in December 2022.

OCEANIC-STROKE (Oral faCtor Eleven A iNhibitor asundexIan as novel anti-thrombotiC - STROKE study) is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study on top of standard-of-care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk TIA.

The primary objectives are to investigate asundexian for prevention of ischemic stroke compared to placebo as well as compare the incidence of ISTH major bleeding.

Its first patient was enrolled in late January 2023.

Combined, the trials are expected to enroll more than 27,000 patients in over 40 countries.

The following abstracts on secondary analysis from the PACIFIC-STROKE study were selected for presentation at the International Stroke Conference, being held from February 8-10 in Dallas, Texas:

Smith EE, Shoamanesh A, Mundl H, et al. Effect of factor XIa inhibition with asundexian on recurrent ischemic stroke according to baseline patterns of infarction on brain MRI: PACIFIC-Stroke.

Khatri P, Shoamanesh A, Mundl H, et al. Effects of the oral factor XIa inhibitor asundexian on intracranial bleeding among patients with acute non-cardioembolic ischemic stroke: PACIFIC-Stroke randomized trial.

The PACIFIC clinical trials form part of the broadest Phase IIb FXIa program in the world, involving more than 4,000 patients to date.

The OCEANIC Phase III clinical development program, currently underway, starts with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enroll more than 27,000 patients in over 40 countries.

The program, one of the largest Phase III endeavors Bayer has ever undertaken, is part of Bayer's commitment to address unmet needs in a growing range of underserved cardiovascular patient communities.

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 inhibitor in thrombosis prevention.

Factor XI is a protein in the blood that is converted into its active enzyme form (Factor XIa) as part of the blood coagulation cascade. 

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 drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of EUR 44.1bn. R&D expenses before special items amounted to EUR 5.3bn.
Login
Username:

Password: