New: Our latest case study on qFibrosis' role in the successful development of Rezdiffra

Case Studies

Madrigal Pharmaceuticals


Resmetirom in patients with liver biopsy-confirmed MASH

This 52-week phase 3 trial demonstrated that Resmetirom met the primary endpoints on biopsy for MASH resolution and fibrosis reduction. Additional analysis using qFibrosis® showed significant reduction in fibrosis with resmetirom versus placebo, further demonstrating treatment response. Patients demonstrated better results when qFibrosis® is utilized, with significant correlations between reduction in qFibrosis® and reduction to PDFF, ALT, AST, and ELF score.

Sagimet Biosciences

FASCINATE-2 Phase 2b

Denifanstat in Biopsy-Confirmed F2/F3 MASH

In this 52-week phase 2b clinical trial, the primary and multiple secondary endpoints assessing MASH resolution and fibrosis improvement were met. qFibrosis® independently yielded a congruent treatment effect with an LS mean change from baseline for Denifanstat at -0.3 vs. placebo at 0.1; p=0.002, validating qFibrosis’ performance with traditional histopathology by an expert liver pathologist and the other standard biomarkers recommended by the FDA.

NorthSea Therapeutics

ICONA Phase 2b

Icosabutate for MASH patients with Type 2 Diabetes

In this 52 weeks study, the largest treatment effect was observed in patients with T2D, with 35.5% of T2D patients treated with 600mg of Icosabutate achieving MASH resolution. Using qFibrosis, a synergic dose response in fibrosis stage regression was observed with a treatment effect size (placebo adjusted) in T2D patients of 13.7% (p=0.32) and 31% (p=0.03) in the 300mg and 600mg treatment arms respectively.

Novartis and Abbvie

TANDEM Phase 2b

Tropifexor plus cenicriviroc combination versus monotherapy in MASH

In this 48-week phase 2b trial, no substantial incremental efficacy was observed with the combination compared to monotherapy on histological endpoints when assessed by a central pathologist. However, when biopsies were re-analyzed using qFibrosis®, combination treatment showed an additive effect in achieving greater fibrosis reduction compared to monotherapy. The results illustrate the additional insights provided by qFibrosis®.


FLIGHT-FXR Phase 2a/b

Tropifexor for MASH

This phase 2 study investigated the FXR agonist tropifexor for treating MASH over 12-48 weeks. Tropifexor showed sustained ALT and hepatic fat fraction reduction versus placebo. However, on central pathologist assessment, greater histologic improvement versus placebo was not observed after 48 weeks of treatment. When biopsies were reassessed using qFibrosis®, tropifexor treatment showed marked liver fat reduction and improvement in fibrosis versus placebo, highlighting qFibrosis® ability to detect subtle changes undetected by standard assessments.

Future-Proofing Pathology

We are always innovating to extract deeper insights from tissue complexity and drive transformative outcomes for our partners. If you would like to explore how a digital pathology platform can improve your findings, let us know.