Bile acid quantification provides insight into the mechanism of action for the treatment of NASH
Targeted analysis supports the development of NASH treatment.
Nonalcoholic steatohepatitis (NASH) is the advanced, progressive form of nonalcoholic fatty liver disease (NAFLD). Both conditions are hepatic diseases associated with metabolic and cardiovascular disorders like obesity, hypertension, and type 2 diabetes (T2D).
Patients with NASH are at an increased risk of mortality compared with the NAFLD population. Therefore, there is a significant unmet need for therapeutics that can effectively manage or reverse the disease progression. Drug developers have the challenge of identifying effective treatments to support this patient population that often represents complex disease manifestations. Because of the diverse pathophysiology of NASH, various mechanisms of action are under investigation in clinical studies.
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Previous studies have shown that elevated bile acid concentrations are associated with the presence and severity of liver disorders. Given the link between bile acids and metabolic regulation, there is growing interest in understanding how bile acid dysregulation may contribute to NASH pathogenesis and progression.
A new study published in the Journal of Hepatology Reports leveraged targeted analysis approaches to evaluate the effects of Pegbelfermin (PGBF) treatment on bile acid metabolism by measuring serum bile acid concentrations in a phase 2a study in patients with NASH. To further explore potential mechanisms underlying these observations, the effect of PGBF on the gut microbiome was evaluated using stool samples from a phase 1 study in healthy overweight or obese adults. Read more about how this study leveraged quantitative biomarker analysis to arrive at the results that revealed a valuable mechanism of action to support insight into a potential therapeutic: https://www.jhep-reports.eu/article/S2589-5559(21)00168-3/fulltext#secsectitle0150
The approach to understanding the mechanism of action of therapeutics offers a pivotal opportunity to develop new drug development and clinical trial models to meet patient needs across various chronic and acute diseases.
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