Bayer AG (OTC:BAYRY) released topline results from the Phase 3 OCEANIC-STROKE study, with its investigational, once daily, oral FXIa inhibitor asundexian.
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The study met its primary efficacy and safety endpoints.
Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.
A blood clot from a source other than the heart causes a non-cardioembolic ischemic stroke. High-risk transient ischemic attack is a temporary blockage of blood flow to the brain, often called a “mini-stroke.
There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy.
William Blair views the Bayer trial update as a positive read-through for Bristol Myers Squibb Co.'s (NYSE:BMY) ongoing milvexian program, which is much needed following the recent announcement of the Phase 3 LIBREXIA-ACS trial with milvexian being halted due to a lack of efficacy.
Analyst Matt Phipps’ key outstanding question remains whether the doses of milvexian being studied across the stroke and AF studies are optimal, with a 25 mg BID dose being used in combination with antiplatelet therapy in LIBREXIA-STROKE and a 100 mg BID dose being used as monotherapy in the LIBREXIA-AF study.
Bristol Myers has not disclosed the level of factor XIa inhibition achieved at these dose levels, but Bayer had previously disclosed roughly 91% inhibition with the 50 mg QD dose of asundexian at trough.
William Blair highlighted that asundexian was previously evaluated versus Eliquis for the prevention of stroke and systemic embolism in the OCEANIC-AF Phase 3 study in patients with AF at risk of stroke.
However, the study was stopped early by the IDMC due to a lack of efficacy. Results from the study and full presentation at the ESC Congress showed clear inferiority to Eliquis despite greater than 90% factor XIa inhibition, and also showed similar factor XIa activity reduction between patients with and without events.
The trial data led many to believe the level of asundexian dosing was insufficient in AF.
Whether a higher dose of milvexian (100mg BID) in the LIBREXIA-AF study can be successful remains to be seen, but this dose level did result in compelling efficacy in the total knee replacement in the AXIOMATIC-TKR Phase 2 trial.
BMY Price Action: BMY stock is up 4.57% at $48.37 at publication on Monday.
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