Bayer ends blood thinner trial early due to lack of efficacy

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.