Bayer starts Phase II trial of BAY3283142 for chronic kidney disease

Bayer has initiated the ALPINE-1 study, a Phase II clinical trial involving BAY3283142, an investigational soluble guanylate cyclase (sGC) activator, aimed at treating patients with chronic kidney disease (CKD). This study may reveal the sGC activator as a promising new therapy for cardiovascular diseases.

CKD affects over 10% of the global population, approximately 850 million people. This progressive condition often goes unrecognized, with symptoms appearing only in advanced stages, making it a significant health concern. CKD is commonly associated with diabetes and is a notable risk factor for cardiovascular disease.

Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, highlighted the importance of this study. "This study marks a significant step forward in our commitment to addressing the high unmet medical need in this patient population and advancing our innovative approach to treat renal disease," he stated. "In addition, this further strengthens our overall development portfolio. We are dedicated to advancing the development of BAY3283142 to improve outcomes for patients with chronic kidney disease and related cardiovascular conditions."

Prof. Christoph Wanner, Senior Professor of Medicine at the University Hospital of Würzburg and Co-Chair of the ALPINE-1 study, also emphasized the study's significance. “The change in demography tells us that we are living longer in the future, and people want to spend this time in good health, with healthy kidneys. The prevalence of chronic kidney disease (CKD) as one of the top 10 leading causes of mortality underscores the pressing need for effective treatment options. The evaluation of the sGC activator in patients with CKD holds promise in addressing a critical unmet medical need in patient care.”

The ALPINE-1 study is a randomized, double-blind, placebo-controlled, multi-center Phase II trial that aims to evaluate the efficacy and safety of BAY3283142 in CKD patients. BAY3283142 is a soluble guanylate cyclase (sGC) activator that takes a novel approach to modulating the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathway, showing potential for broad treatment applications in cardiovascular diseases.

This initiative aligns with Bayer’s broader commitment to cardiovascular and kidney diseases. The company has a leading role in innovation within cardiovascular treatments and continues to explore new therapeutic approaches for both cardiovascular and kidney diseases, reflecting a strategic focus on addressing areas with high unmet medical needs.

Bayer is a global enterprise known for its expertise in health care and nutrition, driven by its mission, "Health for all, Hunger for none." The company's products and services aim to support global health and environmental sustainability. Bayer prioritizes innovation and growth while ensuring reliability and quality, as evidenced by its substantial investment in research and development, amounting to 5.8 billion euros in fiscal 2023.

In summary, Bayer’s ALPINE-1 study represents a significant advance in the search for effective treatments for chronic kidney disease and related cardiovascular conditions. By leveraging innovative sGC activation, Bayer aims to address the pressing health needs of CKD patients, potentially improving their health outcomes and quality of life.