Decision to stop the study early… efficacy is not superior
[의약뉴스] German pharmaceutical company Bayer failed in the phase 3 clinical trial of a new anticoagulant drug candidate.
Bayer announced the efficacy of OCEANIC-AF, a phase 3 clinical trial comparing the oral coagulation factor It was announced on the 19th (local time) that it would be discontinued early due to a shortage.
This decision followed the recommendations of the Independent Data Monitoring Committee (IDMC), which was conducted as part of ongoing surveillance and found that Asundexian was inferior to apixaban in efficacy.
Bayer plans to further analyze the data to understand the results and disclose them at a later date.
Safety data to date are consistent with the previously reported safety profile of Asundexian.
Appropriate steps will be taken to terminate the OCEANIC-AF study and patients participating in the study will be contacted by their physician/researcher to discuss next steps.
IDMC recommended that the OCEANIC-STROKE phase 3 clinical trial continue as planned. OCEANIC-STROKE is evaluating the effectiveness of Asundexian in preventing ischemic stroke in patients following acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack/ministroke.
Other evidence suggests that the combination of anticoagulation and standard care has the potential to provide benefit to patients in the OCEANIC-STROKE study who lack appropriate treatment options.
Additionally, Bayer is planning a Phase 3 clinical trial, OCEANIC-AFINA, to evaluate Asundexian in patients with atrial fibrillation aged 65 years or older who are at high risk for stroke or systemic embolism and considered unsuitable for oral anticoagulant treatment.
OCEANIC-AFINA is not yet recruiting patients, and Bayer has decided to reevaluate the study design in consideration of the OCEANIC-AF decision.
“Although the results of this analysis do not support continuation of the OCEANIC-AF study, we will continue to study Asundexian in the OCEANIC-STROKE study and will continue to study Asundexian in patients requiring antithrombotic treatment,” said Dr. Christian Rommel, Executive Committee Member and Head of Research and Development at Bayer Pharmaceuticals. “We are currently re-evaluating other indications.”
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