Bayer Stops Late-Stage Study for Stroke Prevention Due to Lack of Efficacy

By Helena Smolak

Bayer is discontinuing early a Phase 3 study to test investigational drug asundexian on prevention of stroke and systemic embolism for patients with atrial fibrillation due to lack of efficacy.

The German pharmaceutical-and-agricultural group said late Sunday that the decision is based on a recommendation by the independent data monitoring committee of the study.

The study evaluated the efficacy and safety of asundexian--an oral inhibitor of a protein involved in blood coagulation called Factor XIa--against apixaban, but showed an inferior efficacy of asundexian, Bayer said.

Available safety data are consistent with previously reported safety profiles of asundexian, the company said.

Bayer will continue to analyze the data to better understand the outcome and publish the data, it said.

The company is currently reevaluating other indications in patients who need antithrombotic treatment, said Christian Rommel, head of research and development at Bayer's pharmaceuticals division.

Write to Helena Smolak at [e-mail]

(END) Dow Jones Newswires

November 20, 2023 02:07 ET (07:07 GMT)

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