Bayer’s Asundexian Fails to Prevent Strokes, Jeopardizing $5.5 Billion Blockbuster Hopes

Trial Halt:
Bayer has stopped the phase 3 OCEANIC-AF trial of asundexian, an investigational oral factor XI inhibitor, due to inferior efficacy compared to apixaban in preventing strokes in patients with atrial fibrillation (AF).

Implications:
The failure of asundexian in the OCEANIC-AF trial raises doubts about the potential of Factor XI inhibitors, a class of drugs aimed at reducing bleeding risks associated with anticoagulation therapy.

Continuing Studies:
Despite the halt of OCEANIC-AF, Bayer will continue the OCEANIC-STROKE trial, which compares asundexian to placebo on top of standard antiplatelet therapy for preventing ischemic strokes in patients after an acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

Financial Impact:
The failure of asundexian is a significant blow to Bayer, which had expected the drug to generate over $5 billion in annual sales, potentially offsetting losses from generic competition for its existing anticoagulant, Xarelto.

Industry Impact:
The outcome of the OCEANIC-AF trial may also affect other companies developing Factor XI inhibitors, such as Bristol Myers Squibb with milvexian, which is in phase 3 trials.