89bio Announces U.S. FDA has Granted Breakthrough Therapy Designation for Pegozafermin in Nonalcoholic Steatohepatitis (NASH)
–Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of pegozafermin–
–Discussions with regulatory agencies regarding the NASH Phase 3 program planned for the fourth quarter of 2023–
SAN FRANCISCO, Sept. 21, 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 cardiometabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
“We are thrilled with this validation from the FDA awarding pegozafermin with Breakthrough Therapy Designation, which we expect will be advantageous for finalizing our Phase 3 development strategy in NASH following planned discussions with regulatory agencies in the fourth quarter of 2023,” said Rohan Palekar, Chief Executive Officer of 89bio. “We believe pegozafermin is well positioned as a leading FGF21 analog treatment option with demonstrated strong histology data, best-in-class tolerability, and dosing convenience to date. It has the potential to meet the treatment needs for F2/3 patients as well as compensated cirrhotic (F4) patients. The benefits of this designation include more comprehensive guidance from the FDA on the development program, ability to discuss innovative development plan options, access to a scientific liaison, and potential eligibility for Priority Review.”
BTD was supported by data from the ENLIVEN Phase 2b trial of pegozafermin in patients with NASH. In the study, both the 44mg every-two-week (Q2W) and 30mg weekly (QW) doses met — with high statistical significance — the primary histology endpoints per the FDA guidance regarding endpoints and statistical analysis. The 44mg Q2W and 30mg QW dose groups also demonstrated statistically significant and clinically meaningful improvements in liver fat, non-invasive markers of liver fibrosis and inflammation, and meaningful improvements in other metabolic and lipid markers. The ENLIVEN trial also included biopsy-confirmed F4 patients who were not part of the primary analysis but continued in the study. In a descriptive analysis of these data, 45% of pegozafermin-treated patients experienced at least one-stage improvement in liver fibrosis with no worsening of NASH by week 24 compared with zero out of one patient on placebo. Overall, pegozafermin was generally well-tolerated with a favorable safety profile consistent with prior studies.
BTD is an FDA program designed to expedite the development and eview of product candidates intended for serious or life-threatening conditions. To qualify for this designation, preliminary clinical evidence must indicate that the product candidate may demonstrate substantial improvement over currently available options on at least one clinically significant endpoint.
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