Bayer is making one of the largest drug development bets in its history, advancing a pair of Phase 3 trials for a blood-thinning drug it believes can become a top-selling medicine in the future.
The drugmaker said Wednesday the first patients have been enrolled in the trials, known respectively as OCEANIC-AF and OCEANIC-STROKE and set to include more than 27,000 patients across 40 countries. The trials represent “one of the largest Phase 3 endeavors Bayer has ever undertaken,” the company said in a statement.
The studies are pivotal tests for a blood thinner known as asundexian. The drug is part of an emerging class of medicines known as Factor XIa inhibitors, which are viewed as potentially safer alternatives to blockbuster medicines like Eliquis and Xarelto.
Though the drugs’ prospects took a hit after mixed results in mid-stage tests, Bayer and rival Bristol Myers Squibb have chosen to push forward with Phase 3 trials. The drugmakers believe the medicines may prevent strokes without as much risk of bleeding as associated with Eliquis and Xarelto.
“Despite advances in anticoagulation, potential bleeding risk may be a reason why some patients go untreated and underscores the need for alternative treatments to prevent thrombosis,” said Manesh Patel, principal investigator for the OCEANIC-AF trial, in a statement.
Bayer’s studies will test how well asundexian can prevent different types of strokes. OCEANIC-AF will assess whether asundexian can top Eliquis at preventing strokes and systemic embolisms in patients with atrial fibrillation. OCEANIC-STROKE will compare a regimen of the drug and standard antiplatelet therapy to typical care and a placebo. It’ll test whether Bayer’s drug can better prevent an ischemic stroke or major bleeding in patients who have already had a stroke or related symptoms.
OCEANIC-AF and OCEANIC-STROKE were unveiled in August and enrolled their first participants in December and January, respectively. Both studies could produce results on their primary study goals in 2025, according to a federal clinical trials database.
Bristol Myers, meanwhile, said last month that it’ll soon start a Phase 3 trial for the rival drug, milvexian, it’s developing with Johnson & Johnson.
The results could be critical for both companies, as both Eliquis and Xarelto will lose patent protection later this decade. Eliquis is co-owned by Bristol Myers and Pfizer, while Bayer splits ownership of Xarelto with J&J.
Eliquis generated about $12 billion in revenue in 2022 for Bristol Myers, while Xarelto accounted for around $2.5 billion for J&J, the companies said in earnings reports last week. Bayer is expected to report its 2022 results later this month.
Last month, Bayer and Bristol Myers predicted their Factor XIa inhibitors could each exceed $5 billion in peak annual sales later this decade, if they are successful in clinical studies.