Given the inherent complexity of NASH and other diseases caused by dysregulated lipogenesis, our development strategy includes precision medicine approaches using non-invasive biomarkers to identify both indications that can be treated by denifanstat and patients who are most likely to respond to the drug.
This includes:
- Pharmacodynamic biomarkers, such as tripalmitin, to confirm FASN inhibition and pathway engagement by denifanstat
- Predictive biomarkers incorporating metabolomic and single nucleotide polymorphism (SNP) blood profiling to identify a ‘signature’ that predicts improvements in markers of NASH disease in patients taking denifanstat.
We will continue to validate these biomarkers with the liver biopsy results from our ongoing FASCINATE-2 Phase 2b clinical trial and anticipate developing complementary diagnostic tools to benefit patients, clinicians and payors.
