Bayer initiates Phase II study with first-in-class anti-alpha2 antiplasmin antibody in patients with deep vein thrombosis

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• Anti-alpha2 antiplasmin antibody is being studied in patients with deep vein thrombosis to assess its potential as a thrombolytic
• Anti-alpha2 antiplasmin antibody might also provide potential treatment options in indications of high medical relevance

Bayer announced today the start of a Phase II clinical trial (SIRIUS study) with BAY3018250, an investigational first-in-class anti-alpha2 antiplasmin (anti-α2ap) antibody in patients with deep vein thrombosis (DVT). The results of this study might provide evidence of anti-α2ap antibody’s potential as a treatment option in indications of high medical relevance.

"We are excited to advance our anti-α2ap antibody to the next stage of clinical development in patients with deep vein thrombosis,” said Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceuticals Division and Head of Research and Development. “This study will also help to better understand if the anti-α2ap antibody is suitable as a thrombolytic to treat patient in indications of high medical relevance. By targeting alpha2 antiplasmin, we will have a more precise approach to modulate plasmin to break down thrombotic blood clots."

Following the successful first-in-human trial, the goal of the randomized, double-blind, placebo-controlled, multi-center Phase II study (SIRIUS study) is to assess the efficacy and safety of BAY3018250 in patients with symptomatic proximal deep vein thrombosis. BAY3018250 is designed to target alpha2 antiplasmin. α2ap’s primary function is to inhibit the enzymatic activity of plasmin and thereby balance the formation and dissolution of blood clots.

About Bayer’s Commitment in Cardiovascular Diseases

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio in the field of cardiovascular diseases already includes a number of innovative products and compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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lh (2024-0022E)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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