– New evaluation of cohort 7 knowledge utilizing a three-reader pathologist panel confirmed that 6/19 sufferers scored as having fibrosis stage 4 at baseline (putative F4); excluding these sufferers resulted in larger histological response charges in the sufferers with F2-F3 fibrosis than beforehand reported –
SAN FRANCISCO, Nov. 05, 2022 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical firm centered on the improvement and commercialization of progressive therapies for the therapy of liver and cardio-metabolic illnesses, at this time introduced the presentation of post-hoc exploratory analyses of further knowledge from the paired-biopsy, open-label enlargement cohort (Cohort 7) in the Phase 1b/2a proof-of-concept research evaluating pegozafermin in sufferers with nonalcoholic steatohepatitis (NASH). These knowledge had been featured in a poster presentation (summary #36901) at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2022, being held nearly and in Washington, D.C., from November 4 – 8, 2022. A duplicate of the poster presentation shall be accessible underneath “Scientific Publications” in the pipeline part of 89bio’s web site.
In this open-label cohort, NASH sufferers had been handled as soon as weekly for 20 weeks with 27 mg of pegozafermin. For the main evaluation, biopsies had been learn centrally at baseline and at finish of therapy by a single skilled liver pathologist (central reader). In a post-hoc exploratory evaluation, a panel of three further skilled NASH pathologists (three-reader panel) assessed the identical baseline and finish of therapy slides that had been evaluated by the central reader. The anticipated inter-reader variability widespread in NASH research was noticed.
The three-reader panel scored six of the 19 sufferers as having F4 fibrosis at baseline (putative F4), which was an exclusion criterion for the Phase 1b/2a research. Excluding the putative F4 sufferers resulted in a better proportion of sufferers assembly the registration enabling histological endpoints in comparison with the main evaluation primarily based on the central reader, as proven under.
| Parameter | All sufferers (n=19) | Excluding sufferers with putative F4 fibrosis at baseline (n=13*) |
| ≥ 2 level discount in NAS (%) | 74% | 77% |
| NASH decision with out worsening of fibrosis (%) | 32% | 46% |
| Fibrosis enchancment ≥ 1 stage with out worsening of NASH (%) | 26% | 38% |
*Post-hoc evaluation excluding sufferers with putative F4 fibrosis (n=6) primarily based on scoring by 2 or extra of the three-panel pathologists; cirrhosis was an exclusion criterion on this research
“These latest data showcase pegozafermin’s ability to drive meaningful changes on histology endpoints despite the inherent variability in liver biopsy assessments,” mentioned Dr. Hank Mansbach, Chief Medical Officer of 89bio. “We have incorporated a three-panel consensus read to reduce variability in our ongoing Phase 2b ENLIVEN trial and remain on track to report topline data in the first quarter of 2023. We were also encouraged to observe pharmacological activity with pegozafermin in the small group of F4 patients.”
About pegozafermin
Pegozafermin is a particularly engineered glycoPEGylated analog of fibroblast progress issue 21 (FGF21) being developed for the therapy of non-alcoholic steatohepatitis (NASH) and extreme hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that modulates essential drivers of lipid metabolism and NASH together with triglyceride discount, glycemic management, steatosis, irritation and fibrosis. Pegozafermin was particularly engineered utilizing a novel glycoPEGylated know-how to increase the half-life whereas sustaining efficiency. Pegozafermin is presently being evaluated in the Phase 2b ENLIVEN trial in NASH and is predicted to maneuver into Phase 3 program for SHTG in 2023.
Recent Phase 2 knowledge with pegozafermin in SHTG sufferers demonstrated vital and clinically significant reductions in triglycerides in addition to enhancements in different cardiometabolic measures. Additionally, Phase 1b/2a knowledge with pegozafermin in biopsy-confirmed NASH sufferers demonstrated clinically significant modifications on histology endpoints and non-invasive measures of whole liver well being in addition to a lot of the underlying metabolic comorbidities generally related to NASH.
About 89bio
89bio is a clinical-stage biopharmaceutical firm devoted to the improvement of best-in-class therapies for sufferers with liver and cardiometabolic illnesses who lack optimum therapy choices. The firm is targeted on quickly advancing its lead candidate, pegozafermin, by way of scientific improvement for the therapy of non-alcoholic steatohepatitis (NASH) and extreme hypertriglyceridemia (SHTG). Pegozafermin is a particularly engineered, probably best-in-class fibroblast progress issue 21 (FGF21) analog with distinctive glycoPEGylated know-how that optimizes organic exercise by way of an prolonged half-life. The firm is headquartered in San Francisco with operations in Herzliya, Israel. For extra data, go to www.89bio.com or comply with the firm on LinkedIn.
Forward-looking Statements
Certain statements on this press launch might represent “forward-looking statements” inside the that means of the federal securities legal guidelines, together with, however not restricted to, the therapeutic potential and scientific advantages of pegozafermin, scientific improvement plans and timing for pegozafermin, together with the Phase 2b ENLIVEN trial and the Phase 3 program for SHTG, and the timing for topline knowledge for the ENLIVEN trial shall be ample to fund its anticipated operations. Words akin to “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “develop,” “plan” or the unfavorable of those phrases, and comparable expressions, or statements relating to intent, perception, or present expectations, are ahead wanting statements. While 89bio believes these forward-looking statements are cheap, undue reliance shouldn’t be positioned on any such forward-looking statements, that are primarily based on data accessible to us on the date of this launch. These forward-looking statements are primarily based upon present estimates and assumptions and are topic to varied dangers and uncertainties (together with, with out limitation, these set forth in 89bio’s filings with the SEC), a lot of that are past 89bio’s management and topic to vary. Actual outcomes could possibly be materially completely different. Risks and uncertainties embody: expectations relating to the timing and consequence of the Phase 2b ENLIVEN trial in NASH; expectations relating to the timing of topline knowledge; optimistic outcomes from a scientific research might not essentially be predictive of the outcomes of future or ongoing scientific research; 89bio’s substantial dependence on the success of it lead product candidate; competitors from competing merchandise; the impact of the COVID-19 pandemic on 89bio’s scientific trials and business operations, and the affect of common financial, well being, industrial or political circumstances in the United States or internationally; and different dangers and uncertainties recognized in 89bio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and different subsequent disclosure paperwork filed with the SEC. 89bio claims the safety of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to replace or alter any statements whether or not on account of new data, future occasions or in any other case, besides as required by regulation.
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