Running behind Bristol Myers and J&J, Bayer inches forward in the next-gen blood thinner race
Over the weekend, Bayer took an intermediate step in its quest to chase down Bristol Myers Squibb and J&J in the next-generation blood thinner race.
In a Lancet paper published Sunday detailing a Phase II safety and dose-finding study, Bayer’s experimental drug asundexian reduced the number of bleeding events by 67% compared to Eliquis, a standard of care. Bayer’s next steps are to wrap up another Phase II, finalize the dose and push it into a Phase III study, likely by the end of this year, lead author Manesh Patel told Endpoints News.
“We feel good about the dosing, and we actually feel good about the fact that the higher dose also has similar rates of bleeding,” Patel, a professor at Duke University, said. “It’s encouraging that it’s small numbers, and you don’t want to overinterpret.”
When patients use blood thinners, sometimes the anticoagulatory aspects of the medicine don’t just reduce excess clotting, but normal clotting as well, Patel said. This study aimed to examine how asundexian affected the rates of such events.
It did not, Patel and the paper stressed, look at the efficacy of the drug in differentiating between rates of clotting events compared to standard of care, which will likely be the focus of the upcoming pivotal study. Patel also noted that the total number of bleeding events in the Phase II trial was lower than expected.
Bayer randomized 755 patients about evenly into three separate arms: a 20 mg asundexian dosing arm, a 50 mg asundexian dose cohort and the Eliquis control arm. Almost all patients, 753, were evaluable at the end.
Pooling the two asundexian arms together, Bayer observed four bleeding events across the 503 patients, compared to six bleeding events in the 250 individuals taking Eliquis. As such, the company was able to determine a 67% reduction in bleeding events between the two drugs.
The study enrolled patients older than 45 with atrial fibrillation, though the average age of participants was 73.7 years old. Nearly 3 in 10 patients also had chronic kidney disease.
Asundexian is a Factor XIa inhibitor, part of the same drug class as Bristol Myers and J&J’s next-gen candidate, milvexian. The partners here have a leg up on Bayer in at least one area, having completed a Phase II study observing a lower rate of venous thromboembolism after knee surgery without increasing risk of bleeding.
Factor Xa inhibitors, such as Eliquis and Xarelto, can come with a fatal risk of bleeding, hence the push toward Factor XIa. BMS and J&J are also aiming to launch their Phase III study for post-knee surgery VTE sometime this year.