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FALCON 1, a phase-2b study was performed to study the efficacy of Pegbelfermin (PGBF)in nonalcoholic steatohepatitis (NASH) and stage 3 fibrosis patients.
use of Pegbelfermin (therapeutic protein that impersonates the biological features of fibroblast growth factor-21) therapy can significantly improve the multiple disease biomarkers at week 24 in patients with NASH and stage 3 fibrosis.
FALCON 1, a phase-2b study was performed to study the efficacy of Pegbelfermin (PGBF)in nonalcoholic steatohepatitis (NASH) and stage 3 fibrosis patients.
This post hoc analysis explored the influence of PGBF on NASH-related biomarkers, the link between histological evaluations and noninvasive biomarkers, and concordance between the week twenty-four histologically-determined key outcome response and various biomarkers.
Blood-linked composite fibrosis scores, blood-linked and imaging biomarkers were assessed for NASH people with data from FALCON 1 at the baseline through week twenty-four. The protein signatures of NASH steatosis, inflammation, ballooning, and fibrosis in blood were evaluated via SomaSignal tests. The linear mixed-effect models were fit as per biomarker. Correlations and concordance were measured among the blood-based biomarkers, imaging, and histological metrics.
As found, PGBF remarkably enhanced blood-based combined liver fibrosis scores (enhanced liver fibrosis [ELF], fibrosis-4 index [FIB-4], aspartate aminotransferase-to-platelet ratio index [APRI]), biomarkers of fibrogenesis (monomeric ADAMTS-2-released N-terminal type III collagen propeptide [PRO-C3] and crosslinked ADAMTS-2-released N-terminal type III collagen propeptide [PC3X]), adiponectin, cytokeratin 18 (CK-18), liver fat fraction and all the SomaSignal tests at week 24.
Four key categories, namely: tissue injury, steatosis/metabolism, fibrosis, and biopsy-based metrics were identified as per the correlation analyses between histological and noninvasive evaluations. PGBF had concordant-discordant effects when the key outcome versus the biomarker responses was observed. For measures of liver steatosis and metabolism, the most clear and concordant effects were witnessed. In PGBF arms, a noteworthy link between hepatic fat measured histologically and by imaging was perceived.
PGBF leads to improvement of NASH-linked biomarkers most consistently via improvement of liver steatosis, though there were also improvements in biomarkers of fibrosis and tissue injury/inflammation.
For a better understanding of dynamic changes in disease activity due to the pharmacological therapy of NASH, the results from noninvasive measures plus histologically derived evaluations should be taken into account.
JHEP Reports
Effect of Pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial
Elizabeth A. Brown et al.
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