Asundexian’s Phase III win could also bode well for Bristol Myers Squibb, which is also developing a Factor XIa inhibitor called milvexian for stroke prevention, analysts said.
Bayer’s investigational Factor XIa inhibitor asundexian significantly protected patients against stroke in the Phase III OCEANIC-STROKE study, setting the drug up for a comeback after a previous late-stage stumble.
Without providing specific data, Bayer reported in a press announcement on Sunday that daily treatment with asundexian “significantly reduced the risk of ischemic stroke” versus placebo. OCEANIC-STROKE enrolled more than 12,300 patients who had suffered a non-cardioembolic ischemic stroke or high-risk ischemic attack. Participants were on antiplatelet therapy.
Aside from hitting the primary endpoint, Bayer’s topline readout also showed that there was no increase in major bleeding risk for patients treated with asundexian.
Asundexian’s stroke outcomes are “surprisingly positive,” Leerink Partners told investors in a note on Sunday evening. The OCEANIC-STROKE results come almost three years to the day after Bayer ended the Phase III OCEANIC-AF study of asundexian in atrial fibrillation, driven by what the pharma at the time called the drug’s “inferior efficacy” versus the blockbuster blood thinner Eliquis. Bayer did not provide specific data on the difference between asundexian and Eliquis at that time.
According to a Sunday news release, Bayer will present OCEANIC-STROKE data to regulatory authorities worldwide, with an eye toward marketing authorization applications, though it did not provide a specific timeline. The pharma also promised to present the study’s full findings at an upcoming medical meeting.
The OCEANIC-STROKE readout could have a “bullish readthrough” to another investigational FXIa inhibitor, milvexian, being tested by Bristol Myers Squibb and Johnson & Johnson for secondary stroke prevention. A Phase III readout for the drug is expected in the fourth quarter of next year.
BMO Capital Markets sees a similar upside to BMS and J&J’s candidate: Bayer’s asundexian “acts as an oral Factor XIa inhibitor, similar to Bristol’s milvexian,” the analysts explained, “mildly improving our confidence in Bristol’s overall approach to improve anticoagulant therapies without increasing bleeding risk.”
Like asundexian, milvexian has a checkered development history. An interim analysis earlier this month showed that it was unlikely to meet the primary endpoint in a late-stage study of acute coronary syndrome. The companies ultimately discontinued the trial.
Still, BMO analysts remain cautiously optimistic, noting that they still need to see the full data from OCEANIC-STROKE to better “assess the clinical relevance of benefits” of Factor XIa inhibition on stroke risk.
