Study Design to Validate Biomarkers of Therapeutic Response in Pre-cirrhotic NASH
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1 Study Design to Validate Biomarkers of Therapeutic Response in Pre-cirrhotic NASH Brent A. Neuschwander-Tetri, MD, FAASLD Professor of Internal Medicine Director, Division of Gastroenterology and Hepatology Saint Louis University School of Medicine
2 COI Consultant/Advisor: Allergan Arrowhead Bristol Myers Squibb ConSynance Cymabay Enanta Gilead Intercept Karos Lexicon Madrigal NGM
3 BEST Resource Pharmacodynamic/Response Biomarker definition A biomarker used to show that a biological response has occurred in an individual who has been exposed to a medical product or an environmental agent. A pharmacodynamic/response biomarker is a biomarker whose level changes in response to an exposure to a medical product or an environmental agent.
4 BEST Pharmacodynamic/Response Biomarker Uses Provide early evidence that a treatment might have an effect on a clinical endpoint of interest Provide evidence of target engagement It is often very difficult to statistically power an early phase clinical trial to demonstrate a meaningful change in a clinical outcome, and many clinical outcomes require a long period of time before a meaningful change can be demonstrated For medical product development, e.g., did the drug have the pharmacodynamic effect thought to be related to clinical effect (overlap with monitoring biomarkers)
5 BEST Pharmacodynamic/Response Biomarker Uses cont d Assess a pharmacologic endpoint related to safety concerns Provide useful information for patient management, e.g., Whether to continue treatment or to adjust dose
6 Progression of NAFLD Need for Biomarkers Steatosis Normal Liver Steatohepatitis Intermediate stages of fibrosis Cirrhosis Death Transplant HCC
7 Progression of NAFLD Need for Biomarkers Steatosis Normal Liver Hard outcomes Steatohepatitis Intermediate stages of fibrosis Cirrhosis Death Transplant HCC
8 Progression of NAFLD Need for Biomarkers Steatosis Normal Liver Hard outcomes Steatohepatitis Intermediate stages of fibrosis Cirrhosis Death Transplant HCC Biomarkers: ALT Clinical algorithms Lipidomics Proteomics Circulating mirnas, exosomes, etc MR Genomic risks Clinical algorithms Elastography VCTE ARFI/SWE MRE Proteomics Other serum markers Genomic risks Biopsy HVPG Imaging contour Elastography Breath tests Quant fxn testing Clinical: Ascites Varices Encephalopathy
9 Percent of patients Issue: liver biopsy as a comparator for biomarkers Spontaneous changes over time? Placebo group change in fibrosis 100% 80% Fibrosis change Worse 60% 40% No change 20% 0% Better
10 Percent of patients Issue: liver biopsy as a comparator for biomarkers Trial: 30 seconds supine Ratziu, et al. Gastroenterology 2005,128: patients with suspected NAFLD Two simultaneous biopsies Independent grading and staging (Brunt criteria) 100% 80% 60% 40% Fibrosis change Worse No change 20% 0% Better
11 Fibrosis Progression Visualizing changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Bridging (stage 3) PP and PV (stage 2) 1 PP or PV (stage 1) None < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
12 Fibrosis Progression Visualizing changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Bridging (stage 3) PP and PV (stage 2) 1 PP or PV (stage 1) None 2 < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
13 Fibrosis Progression Visualizing changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Bridging (stage 3) PP and PV (stage 2) PP or PV (stage 1) Ultimate therapeutic goal: Resolution of NAFLD Resolution of fibrosis 1 None 2 < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
14 Fibrosis Progression Visualizing changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Bridging (stage 3) PP and PV (stage 2) PP or PV (stage 1) None Possible trial response: Improvement of NAFLD Improvement of fibrosis 2 1 < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
15 Fibrosis Progression Visualizing changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Possible trial response: Improvement of NAFLD Improvement of fibrosis Δ NAFLD Bridging (stage 3) PP and PV (stage 2) Δ Fibrosis 2 1 PP or PV (stage 1) None < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
16 Percent of subjects FLINT primary endpoint vs NASH resolution Improvement in NAFLD activity score* (NAS) 2 pts * NAS = steatosis grade (0-3) + inflammation grade (0-3) + ballooning grade (0-2) No worsening of fibrosis p = NASH resolution 50% 60% 40% 50% 30% 40% p = 0.08 (NS) 20% 10% 0% 21% (23/109) Placebo 46% (50/110) OCA 25 mg/day 30% 20% 10% 0% 13% 22% Placebo OCA Neuschwander-Tetri et al, Lancet 2015;385:
17 Percent of subjects improved Change in score Improvement in fibrosis and NASH resolution Δ Fibrosis p = % 50% 40% 30% 20% 10% 0% 19% Placebo 35% OCA 1,0 0,6 0,2-0,2-0,6-1,0 p = Placebo OCA Neuschwander-Tetri et al, Lancet 2015;385:
18 Goals of treatment response measures Δ NAFLD that predicts: Reduction in fibrosis? NASH resolution? Δ Fibrosis that predicts: Reduction in progression to cirrhosis and its complications (death, ascites, varices, HE, HCC)
19 Fibrosis Progression Hypothetical concepts in changes in NASH severity and fibrosis stage (Death/transplant) Decompensated cirrhosis Compensated cirrhosis Possible trial response: Improvement of NAFLD Not NASH resolution Δ NAFLD Bridging (stage 3) PP and PV (stage 2) 2 1 PP or PV (stage 1) None < 5% steatosis Steatosis only Steatosis w/ inflammation, indeterminate NASH NAFLD severity Steatohepatitis
20 Hypothetical test QuantiFib 1.0 Δ QuantiFib Δ Fibrosis (categorical)
21 Hypothetical test QuantiFib 1.0 Δ QuantiFib Δ Fibrosis (continuous)
22 Hypothetical test QuantiFib 2.0 Δ QuantiFib Δ Fibrosis (continuous)
23 QuantiFib Index hits record high! Public numbed by endless fibbing
24 Summary Design: collect as much data on potential biomarkers as can be afforded Data from ongoing trials needed for correlation with changes in histology The next 1-3 years: much more data expected Histology is an imperfect comparator Role of treatment in biomarker changes is unknown Treatment specific changes in biomarkers (eg K18 fragments with caspase inhibitors) Treatment agnostic changes will be identified by comparing results across trials
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