Innovative Medicines Unit, Grünenthal Innovation, Zieglerstrasse 6, 52078 Aachen, Germany; TherapeutAix, Juttastrasse 18, 52066 Aachen, Germany.
Innovative Medicines Unit, Grünenthal Innovation, Zieglerstrasse 6, 52078 Aachen, Germany.
Drug Discov Today. 2019 Feb;24(2):560-566. doi: 10.1016/j.drudis.2018.09.020. Epub 2018 Oct 3.
Nonalcoholic steatohepatitis (NASH) is emerging as a major public health issue for the 21st century and is associated with significant liver-related morbidity and mortality. At present, there are no approved drug therapies for NASH. Consequently, NASH has become the focus of significant public and private research and development. In this review, we highlight the research and development (R&D) challenges and opportunities in this emerging therapeutic area. In particular, we consider the impact of the development of new biomarker strategies on clinical trial execution and design, and the positioning of single and combination therapies in future approaches to the treatment of NASH.
非酒精性脂肪性肝炎（NASH）正成为 21 世纪的一个主要公共卫生问题，与显著的肝脏相关发病率和死亡率相关。目前，尚无批准用于 NASH 的药物治疗方法。因此，NASH 已成为重要的公共和私人研究和开发的重点。在这篇综述中，我们强调了这一新兴治疗领域的研究和开发（R&D）挑战和机遇。特别是，我们考虑了新的生物标志物策略的发展对临床试验执行和设计的影响，以及单药和联合疗法在未来治疗 NASH 方法中的定位。
