{"id":765811,"date":"2023-06-24T05:04:09","date_gmt":"2023-06-24T09:04:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/data-from-89bios-enliven-phase-2b-trial-of-pegozafermin-in-patients-with-nonalcoholic-steatohepatitis-nash-published-in-the-new-england-journal-of-medicine-and-simultaneously-presented-in-a\/"},"modified":"2023-06-24T05:04:09","modified_gmt":"2023-06-24T09:04:09","slug":"data-from-89bios-enliven-phase-2b-trial-of-pegozafermin-in-patients-with-nonalcoholic-steatohepatitis-nash-published-in-the-new-england-journal-of-medicine-and-simultaneously-presented-in-a","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/data-from-89bios-enliven-phase-2b-trial-of-pegozafermin-in-patients-with-nonalcoholic-steatohepatitis-nash-published-in-the-new-england-journal-of-medicine-and-simultaneously-presented-in-a\/","title":{"rendered":"Data from 89bio\u2019s ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH) Published in The New England Journal of Medicine and Simultaneously Presented in a Late-breaker Session at the EASL International Liver Congress"},"content":{"rendered":"
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\n \u2013 ENLIVEN results demonstrated that treatment with pegozafermin 30mg weekly and 44mg every-two-week doses resulted in statistically significant changes on both primary histology endpoints \u2013<\/em>\n <\/p>\n

\n \u2013 New data showed pegozafermin resulted in significant benefit across several key sub populations of NASH patients, and that adding pegozafermin to patients taking GLP-1 therapies improved key NASH measures \u2013<\/em>\n <\/p>\n

\n \u2013 Discussions with regulatory agencies regarding advancement into Phase 3 trials in NASH planned for the second half of 2023 \u2013<\/em>\n <\/p>\n

SAN FRANCISCO, June 24, 2023 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH) were published online<\/a> in the New England Journal of Medicine<\/em> (NEJM<\/em>). The data were simultaneously presented in a late-breaking oral session today at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary.<\/p>\n

The published manuscript titled \u201cA Randomized, Controlled Trial of the FGF21 Analog Pegozafermin in NASH\u201d is available online. A copy of the EASL oral presentation will be accessible under \u201cScientific Publications\u201d in the pipeline section of 89bio\u2019s website<\/a>.<\/p>\n

“As a physician, I know how important it is to provide patients with therapies that can be impactful across a broad population of individuals with NASH, especially ones that can easily blend into their daily lives,\u201d said Rohit Loomba, M.D., MHSc, chief of the Division of Gastroenterology and Hepatology at University of California San Diego School of Medicine, and lead study author who presented the data at EASL. \u201cIt\u2019s both incredibly encouraging and exciting to see the positive, consistent results from this research across all aspects \u2013 efficacy, safety, tolerability, and dosing convenience.\u201d<\/p>\n

The randomized, double-blind, placebo-controlled 24-week Phase 2b ENLIVEN trial evaluated 219 adult patients of whom 192 had biopsy-confirmed fibrosis stages F2-F3 NASH and NAS \u2265 4 for 24 weeks. In this trial, treatment with 44mg every-two-week (Q2W) and 30mg (QW) dosing groups resulted in statistically significant changes on both primary histology endpoints demonstrating at least one-stage fibrosis improvement without worsening of NASH (27% and 26%, respectively) at 3.5 times the placebo rate (7%) and NASH resolution without worsening of fibrosis (26% and 23%, respectively), between 12 to 14 times the placebo rate (2%). Treatment with pegozafermin also led to clinically meaningful changes compared to baseline in liver fat and other key non-invasive tests (NITs) of liver inflammation and fibrosis. Improvements were observed in HbA1c, adiponectin and across lipid markers that are important factors for an effective treatment for NASH. In addition, reductions in liver and spleen volume were observed. The trial included 14 biopsy confirmed NASH patients with compensated cirrhosis (F4 patients) who were not part of the primary analysis, but continued in the study, 12 of which underwent a follow-up biopsy at Week 24. Five out of eleven of these patients treated with pegozafermin had fibrosis improvement \u22651 stage without worsening of NASH.<\/p>\n

\u201cNASH is highly associated with metabolic syndrome and increased cardiovascular risk, driving its impact far beyond the liver. Data from ENLIVEN show the promise of FGF21 analogs and potential of pegozafermin as a mainstay treatment for NASH, given it addresses both liver pathology and the underlying metabolic overload that drives it,\u201d said Arun J. Sanyal, M.D., Interim-Chair of the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University \/ VCUHealth. \u201cI am thrilled to see the strong efficacy data across the two FDA approvable histology endpoints, potential to benefit patients already on GLP-1 therapies, and the impressive results across markers of total liver health, which is critically important for this patient population.\u201d<\/p>\n

New results presented at EASL showed:<\/p>\n