Bayer has ended a clinical trial for its new atrial fibrillation (AFib) drug much earlier than planned based on recommendations from the Independent Data Monitoring Committee (IDMC). OCEANIC-AF is a phase III study comparing Bayer’s oral factor XIa inhibitor, asundexian, with the oral anticoagulant (OAC) apixaban in AFib patients facing a high stroke risk. The IDMC recommended Bayer stop the trial early due to asundexian’s inferior efficacy compared to apixaban.
Patients currently enrolled in the trial will be contacted by their physicians to discuss how they should proceed.
OCEANIC-AF represents one of three multicenter, international, randomized phase III clinical trials intended to examine the safety and effectiveness of asundexian. Another one of those trials, OCEANIC-STROKE, is designed to compare asundexian with a placebo in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The IDMC has recommended Bayer continue with OCEANIC-STROKE as planned.
A third trial, OCEANIC-AFINA, is intended to compare asundexian with a placebo in patients with AFib who face a high risk of stroke or systemic embolism and are ineligible for OAC therapy. That trial has not yet started enrolling patients, and Bayer has said it will reevaluate its design before moving forward in light of this unexpected change of plans.
“Although the results from this analysis do not support the continuation of the OCEANIC-AF study, we will continue investigating asundexian in the OCEANIC-STROKE study and are currently reevaluating other indications in patients in need of antithrombotic treatment,” Christian Rommel, PhD, global head of research and development for Bayer, said in a statement.
In the same statement, Bayer emphasized that asundexian is still in the investigational phase and has not been approved for any indication in any country at this time. Asundexian is one of multiple XIa inhibitors currently being studied as potential anticoagulation treatments. Milvexian, for example, is currently being guided through the approval process as part of a collaboration between Bristol Myers Squibb and Johnson and Johnson.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.