Berlin, Germany, August 22, 2024 – Bayer announced today the start of the ALPINE-1 study, a Phase II clinical trial with BAY3283142, an investigational soluble guanylate cyclase (sGC) activator, in patients with chronic kidney disease (CKD). The results of this study have the potential to provide evidence of the sGC activator as a viable treatment option for cardiovascular diseases.

2024年8月22日，德国柏林——拜耳公司今天宣布开始ALPINE-1研究，这是一项II期临床试验，使用研究性可溶性鸟苷酸环化酶（sGC）激活剂BAY3283142治疗慢性肾病（CKD）。这项研究的结果有可能提供sGC激活剂作为心血管疾病可行治疗选择的证据。

CKD is a progressive condition that affects more than 10% of the global population, totaling approximately 850 million individuals. It is a common and potentially deadly condition that is widely underrecognized. It progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease.

CKD是一种渐进性疾病，影响全球人口的10%以上，总计约8.5亿人。这是一种普遍存在且可能致命的疾病，但人们普遍认识不到。它进展缓慢且不可预测，许多症状直到疾病进展顺利才出现。CKD是糖尿病最常见的并发症之一，也是心血管疾病的独立危险因素。

“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,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “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.”

拜耳制药部门研发主管 Christian Rommel 博士表示：“这项研究标志着我们朝着解决该患者群体中大量未满足的医疗需求和推进治疗肾病的创新方法的承诺迈出了重要一步。此外，这进一步增强了我们的整体开发组合。我们致力于推进 BAY3283142 的开发，以改善慢性肾病和相关心血管疾病患者的治疗效果。

“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,” said Prof. Christoph Wanner, Senior Professor of Medicine in the Department of Clinical Studies and Epidemiology, University Hospital of Würzburg and Co-Chair of the ALPINE-1 study. “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.”

维尔茨堡大学医院临床研究和流行病学系高级医学教授、ALPINE-1 研究联合主席 Christoph Wanner 教授表示：“人口结构的变化告诉我们，未来我们的寿命会更长，人们希望在这段时间里身体健康，肾脏健康。慢性肾病 (CKD) 是十大主要死亡原因之一，其患病率凸显了对有效治疗方案的迫切需求。对 CKD 患者使用 sGC 激活剂的评估有望解决患者护理中尚未满足的关键医疗需求。”

Following the successful first-in-human trials, the goal of the randomized, double-blind, placebo-controlled, multi-center Phase II ALPINE-1 study is to assess the efficacy and safety of BAY3283142 in patients with chronic kidney disease. BAY3283142 is a soluble guanylate cyclase (sGC) activator that represents an innovative approach to modulating the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathway with a broad treatment potential in cardiovascular diseases.

继首次人体试验成功之后，随机、双盲、安慰剂对照、多中心 II 期 ALPINE-1 研究的目标是评估 BAY3283142 对慢性肾病患者的疗效和安全性。BAY3283142 是一种可溶性鸟苷酸环化酶 (sGC) 激活剂，代表了一种调节一氧化氮 (NO)-可溶性鸟苷酸环化酶 (sGC)-环鸟苷酸单磷酸 (cGMP) 通路的创新方法，在心血管疾病方面具有广泛的治疗潜力。