Express results in positive proof-of-concept clinical trials for innovative therapies targeting multiple drivers of NASH

▎89bio, the editor of WuXi AppTec's content team, recently announced that its investigational therapy pegozafermin (formerly BIO89-100) for the treatment of nonalcoholic steatohepatitis (NASH) has been obtained in a phase 1b/2a proof-of-concept clinical trial.
Positive result
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In a cohort of 20 patients, 63% achieved a 2-point improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) without worsening liver fibrosis
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Clinically meaningful improvements were also observed in NASH symptom clearance and improvement in fibrosis, two registration-supporting clinical endpoints
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Pegozafermin is a potential "best-in-class" analog of fibroblast growth factor 21 (FGF21)
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FGF21 is an endogenous metabolic hormone that regulates energy expenditure as well as glucose and lipid metabolism
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Pegozafermin utilizes the company's proprietary glycosyl pegylation technology to extend the half-life and optimize biological activity of native FGF21
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It is currently in Phase 2b clinical trials for the treatment of NASH and severe hypertriglyceridemia
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In this single-arm patient cohort, NASH patients with biopsy-confirmed liver fibrosis stages F2 and F3 received pegozafermin for 20 weeks
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At baseline, 65% of patients were in stage F3 fibrosis
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Of the 20 registered patients, 19 had tissue biopsies at the end of treatment, and the results showed that 63% of patients achieved a 2-point improvement in NAS without worsening fibrosis, and 74% achieved a 2-point improvement in NAS
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Image source: 89bio's official website In addition, 32% of patients met the criteria for clearance of NASH symptoms and no worsening of liver fibrosis, 26% of patients met the criteria for grade one improvement in liver fibrosis and no worsening of NASH symptoms, and 47% of patients achieved NASH Symptoms cleared or liver fibrosis improved
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Image source: 89bio's official website In addition, several key non-invasive tests related to liver fibrosis, risk of fibrosis, and clearance of NASH symptoms achieved clinically meaningful improvements
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In addition to improving liver health, the therapy also had significant positive effects on blood sugar control, blood lipids, and body weight
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Image source: Reference [2] "The overall data for Pegozafermin are encouraging, including clinically meaningful changes in histological endpoints, impressive changes in all non-invasive assessments related to overall liver health, and cardiovascular Significant changes
from baseline in markers and glycemic control
," said Dr.
Rohit Loomba, director of the UC San Diego Center for Nonalcoholic Fatty Liver Disease Research and principal investigator of the clinical trial.
"NASH is a complex disease that When considering treatment options for our patients, it is important to address overall liver health as well as the underlying drivers of treating disease
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"Reference: [1] Pegozafermin (BIO89-100) Phase 1b/2a NASH Histology Cohort Topline Results.
Retrieved January 25, 2022, from https://ir.
89bio.
com/static-files/4046a1f3-c63d-40aa- ba18-af4f36711a9e[2] 89bio Reports Positive Topline Results from an Expansion Cohort of the Phase 1b/2a Trial of Pegozafermin (BIO89-100) for the Treatment of NASH.
Retrieved January 25, 2022, from https://ir.
89bio.
com/news-releases/news-release- details
/ 89bio-reports-positive-topline-results-expansion-cohort-phase
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.

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