Bayer held its virtual Pharma Media Day on Wednesday to showcase its transformation in the pharmaceutical business, which will significantly help patients with diseases remaining difficult to treat.

Kim So-young, Bayer's head of thrombosis and vascular diseases division, explains the company's efforts to develop a Factor XI inhibitor as a new generation of anticoagulants.
Kim So-young, Bayer's head of thrombosis and vascular diseases division, explains the company's efforts to develop a Factor XI inhibitor as a new generation of anticoagulants.

Against this backdrop, Kim So-young, Bayer's head of thrombosis and vascular diseases, presented the company's works on Factor XI (FXI)-targeting compound.

"For decades, Bayer has been at the forefront of anti-coagulation medicine," Kim said. "However, there are still millions of patients who do not have access to such treatment due to an increased risk of bleeding."

To resolve this issue, Kim said, Bayer has focused on FXI-targeting compound, a new anti-coagulation class that goes beyond the current standard of care, and provides a wide range of treatment opportunities.

"FXI is a naturally occurring enzyme that is part of the coagulation cascade, which, as evidence suggests, plays a key role in the formation of pathological blood clots, and consequently, thrombosis," Kim said. "Bayer discovered the significance of FXI inhibition in fighting thrombosis by studying ethnic groups with a lower risk of suffering from strokes and blood clots."

While FXI deficiency can be associated with a mild tendency to bleed, carriers do not usually suffer from strong spontaneous bleeding events, she noted.

Kim explained that people with FXI deficiency have lower risks of deep-vein thrombosis and stroke than the general population, showing that inhibiting the production of FXI might be a promising way to prevent the formation of blood clots while maintaining normal hemostasis.

"Therefore, Factor XI inhibition could offer a novel safety and efficacy profile, making it possible to treat millions of cardiovascular patients left without a treatment option," Kim said.

The development of anticoagulants targeting factor FXI is also regarded as a more meaningful attempt for Asians with a higher risk of bleeding than Westerners.

Asked about the prospect of such a treatment for Asians and researches on the Asian cohort in the clinical trials underway, Kim said, "The fact that Asians have a higher risk of bleeding than Westerners is one of the important issues in anticoagulant therapy, and all three candidate substances under development have included Japan and China as clinical trial countries."

The company has also confirmed the mechanism of action in Asians through pharmacokinetic studies, she added.

Kim explained that the company is conducting phase 2 clinical trials in patients with high unmet needs, such as those with heart disease or end-stage renal disease who do not receive sufficient standard treatments, and will be able to unveil the results by 2022.

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