Bayer’s stock price has plummeted to its lowest since 2005 after a clinical trial investigating the anti-coagulant drug asundexian was stopped early due to lack of efficacy.
The Phase III OCEANIC-AF trial (NCT05643573) aimed to determine asundexian’s use as a treatment for people living with atrial fibrillation in a bid to prevent strokes or systemic embolisms.
The Independent Data Monitoring Committee (IDMC) found that asundexian was inferior in terms of efficacy when compared to the control arm of the trial. The OCEAN-AF trial was a part of the overall OCEAN Phase III programme. However, the committee recommended continuing another Phase III OCEANIC-STROKE trial (NCT05686070) examining the use of the drug in stroke patients.
Following the announcement on 19 November 2023, the German pharmaceutical firm’s stock value dropped from €41.45 ($45.38) per share down to €30.77 ($33.68), as of 28 November. It is the lowest price in 18 years. The last time Bayer’s stock price sat at around €30 ($32.98) per share was in November 2005.
Bayer’s global head of research Christian Rommel said: “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 revaluating other indications in patients in need of antithrombotic treatment.”
The multicentre, randomised, double-blind trial was evaluating asundexian, an oral coagulation factor XI inhibitor, against Bristol Myers Squibb’s Eliquis (apixaban).
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Previously, Clinical Trials Arena reported that asundexian’s likelihood of approval dropped to 10% in atrial fibrillation and down to 4% in ischaemic stroke following the termination.
According to GlobalData’s Pharmaceutical Intelligence Center, the drug is estimated to reach total global sales of around $150m by the end of 2026, with the figure expected to grow to $927m by the end of 2029.
GlobalData is the parent company of Clinical Trials Arena.
This is not the first clinical trial Bayer has seen come to a halt this month. Earlier this month, the company announced plans to withdraw its new drug application in the US for Aliqopa (copanlisib). The drug failed to meet its primary endpoint of progression-free survival in the CHRONOS-4 trial in relapsed follicular lymphoma patients.
Conversely, Bayer also saw success earlier in November with positive interim results from a Phase IV real-world trial investigating Kerendia (finerenone) in patients with chronic kidney disease.