89bio announces the first positive results of an expansion

  • 63% of patients achieved an improvement of 2 points or more in NAS without worsening of fibrosis; clinically meaningful improvements on registration enabling endpoints of NASH resolution (32%) and fibrosis improvement (26%)
  • Robust changes on multiple noninvasive liver tests, markers of cardiovascular health and glycemic control support the potential of pegozafermin as a compelling treatment option for NASH
  • Phase 2b ENLIVEN trial underway in NASH patients with results expected in the first half of 2023
  • Conference call and webcast today at 1:30 p.m. PST/4:30 p.m. EST

SAN FRANCISCO, Jan. 24, 2022 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of liver and cardiometabolic diseases, today announced positive initial results from an open-label expansion cohort of 20 patients (Cohort 7) in the Phase 1b/2a proof-of-concept study evaluating pegozafermin (formerly BIO89-100) for the treatment of NASH.

“The totality of pegozafermin data is promising with clinically meaningful changes on histology endpoints, impressive changes on all non-invasive assessments of total liver health, and significant changes from baseline. in cardiovascular markers and glycemic control,” said Rohit Loomba MD, MHSc, director of NAFLD Research Center, University of California San Diego and principal investigator of the study. “NASH is a complex disease and addressing overall liver health and addressing the underlying disease factors is important to consider treatment options for our patients.”

In this single-arm cohort, NASH patients with biopsy-confirmed fibrosis stage F2 and F3 were treated once weekly for 20 weeks with pegozafermin 27 mg. At baseline, 65% of patients were at stage F3 fibrosis. Of the 20 patients included, 19 underwent an end-of-treatment biopsy and the results for these 19 patients were as follows:

Table: Histological results

Improvement of 2 points or more in NAS without worsening of fibrosis1 (main criterion) 63 %
NAS improvement of 2 points or more1 74 %
Resolution of NASH without worsening fibrosis 32 %
One-step improvement in fibrosis without worsening of NASH 26 %
Resolution of NASH or improvement of fibrosis 47 %

NAS = NAFLD activity score
1 A 2-point improvement in NAS score required a 1-point improvement in bloating or inflammation

The results also showed clinically meaningful and meaningful changes in key noninvasive tests (NITs) associated with fibrosis, risk of fibrosis, or resolution of NASH.

Table: Non-invasive tests (NIT) [marker of]

Mean change from baseline at week 20 Responder rate by clinically relevant thresholds
MRI-PDFF [liver fat content]1 -64%*** 100%/78% [≥ 30%/≥ 50%]
ALT (alanine aminotransferase) [liver damage]2 -46%*** 71%3 [≥ 17 U/L]
QUICK scoring [risk for advanced fibrosis]4 -76%*** 88% [≤ 0.35]
VCTE [liver stiffness]5 -31%*** 72% [> 20% decrease]
Pro-C3 [collagen deposition]6 -20%*** 63% [> 15% decrease]

***p1 Changes from baseline ≥30% and ≥50% correlated with improvement in NASH
2 Changes in ALT ≥ 17 U/L have been correlated with histological improvement
3 In patients with elevated ALT as defined by ≥30 U/L in females and ≥40 U/L in males (n=14)
4 The FAST score is a composite of imaging and blood markers and measured on a scale of 0 to 1, a score ≤ 0.35 predicts fibrosis stage F0/F1 and NAS 5 VCTE is a Fibroscan assessment, >20% reduction correlated with improvement in fibrosis
6 Pro-C3 is a blood-based measure, a >15% reduction has been correlated with improvement in fibrosis

“NASH is a multi-faceted disease that is difficult to diagnose and manage appropriately. Liver health NITs and associated measures such as liver fat content, lipids, glycemic control and body weight are critically important for the successful management of patients with NASH,” said Stephen. Harrison, MD, Medical Director of Pinnacle Clinical Research. “The 89bio NITs used in this study provide clinically meaningful information because they assess the whole liver and are therefore likely to be good indicators of disease improvement.”

In addition to a significant improvement in liver health, pegozafermin treatment also had significant positive effects on glycemic control, lipids, and body weight.

Table: Cardio-metabolic parameters

Mean change from baseline at week 20
Absolute change in HbA1c1 -0.9%**
Triglycerides2 -32%***
LDL-C -13%*
HDL-C +23%***
Weight -4%***

*p1 In patients with HbA1c ≥ 6.5% at baseline (n=10); patients were all taking concomitant diabetes medications
2 In patients with elevated triglycerides at baseline (n = 11); the reduction was -26% over the whole population

In 83 pegozafermin-treated patients in the full Phase 1b/2a study, pegozafermin continues to be generally well tolerated with a favorable safety profile. There were no drug-related serious adverse events, only one treatment-related discontinuation, no tremors and no hypersensitivity reactions were observed. In the open-label histology cohort, the most commonly reported treatment-related adverse events were nausea, diarrhea, vomiting, and injection site reactions, most of which were rated as mild.

“We are very pleased with the comprehensive data from our Phase 1b/2a study showing promising efficacy and safety and the encouraging histological results in this cohort further support pegozafermin as a promising drug for the treatment of NASH,” said Hank Mansbach, Medical Director. from 89bio. “We look forward to seeing results from our ongoing ENLIVEN Phase 2b trial, which will evaluate pegozafermin in over 200 NASH patients with follow-up biopsy after 24 weeks of treatment. These results also bode well for our ongoing ENTRIGUE Phase 2 trial in patients with severe hypertriglyceridemia (SHTG) with data expected in the first half of 2022.”

Information about today’s conference call
89bio will host a conference call and webcast at 1:30 p.m. PST / 4:30 p.m. EST today, January 24, 2022. Analysts and investors can participate in the conference call by dialing (877) 705-6003 for domestic callers and +1 (201) 493-6725 for international callers, using conference ID 13726359. The webcast can be viewed live on the Events & Presentations page in the Investors section of 89bio’s website, www. 89bio.com. The webcast will be archived on the Company’s website for at least 30 days after the conference call.

About pegozafermin
Pegozafermin is a potentially best-in-class fibroblast growth factor 21 (FGF21) analog and an ideal candidate for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that modulates important drivers of NASH, including glycemic control, steatosis, inflammation, and fibrosis. Pegozafermin has been specially designed using unique glycoPEGylated technology to extend half-life while maintaining potency. Pegozafermin combines efficacy, optimal dosing convenience, and favorable safety and tolerability. Recent Phase 1b/2a data with pegozafermin in biopsy-confirmed NASH patients demonstrated clinically meaningful changes in histological parameters and noninvasive measures of total liver health, in NASH patients as well as numerous underlying metabolic comorbidities commonly associated with NASH. Pegozafermin is currently being evaluated in the Phase 2b ENLIVEN trial in NASH and the Phase 2 ENTRIGUE trial for the treatment of SHTG.

About 89bio
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The Company’s lead product candidate, pegozafermin, is a specifically designed glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco and operates in Herzliya, Israel. For more information, visit www.89bio.com or follow the company on LinkedIn.

Forward-looking statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of federal securities laws, including, but not limited to, the therapeutic potential and clinical benefits of pegozafermin for the treatment of NASH, the efficacy and safety of pegozafermin, the potential of pegozafermin as a compelling treatment option for NASH, timeline of data from the ENLIVEN Phase 2b trial and the ENTRIGUE Phase 2 trial and the relationship between the results of the expansion cohort and the ongoing ENTRIGUE Phase 2 trial. Words such as “may”, “could”, “will”, “aim”, “intend”, “should”, “might”, “may”, “should”, “expect” , “believes”, “designs”, “estimate”, “predict”, “potential”, “develop”, “plan” or the negative form of these terms, and similar expressions, or statements concerning the intention, the belief or current expectations, are forward-looking statements.Although 89bio believes that these forward-looking statements are reasonable, undue reliance should not be placed on these forward-looking statements, which are based on information available to us as of the date of this release. These forward-looking statements are based on current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the SEC), many of which are beyond the control of 89bio and are subject to change. Actual results may vary. significantly different. The risks and uncertainties include: positive results from a clinical study are not necessarily predictive of the results of future or ongoing clinical studies; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, its Quarterly Reports on Form 10-Q and other subsequent disclosure documents filed with the DRY. 89bio claims the safe harbor protection contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or change any statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor contacts:
ryan martins
Financial director
[email protected]

Media Contact:
Peter Duck
[email protected]

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