The nonalcoholic steatohepatitis (NASH) drug development graveyard: established hurdles and planning for future success.
Joost P H DrenthJörn Markus SchattenbergPublished in: Expert opinion on investigational drugs (2020)
The main goal of NASH pharmacotherapy is to halt or reverse hepatic fibrosis or to achieve the resolution of steatohepatitis. There is an intense competition to develop compounds with disease-modulating properties with a focus on anti-metabolic, anti-inflammatory or anti-fibrotic properties. Numerous study programs, even in late-phase trials, have been halted because of lack of efficacy, safety concerns or drug-drug interactions. This underscores the urgent need to provide robust preclinical data and an extensive clinical trial program that builds on reliable data generated in earlier stages of clinical development before moving into late stage development.
Keyphrases
- clinical trial
- anti inflammatory
- electronic health record
- big data
- public health
- quality improvement
- signaling pathway
- current status
- emergency department
- idiopathic pulmonary fibrosis
- liver fibrosis
- machine learning
- study protocol
- cell therapy
- randomized controlled trial
- data analysis
- mesenchymal stem cells
- double blind
- phase ii
- drug induced