89bio To Present Data From Phase 1b/2a Study of BIO89-100 In NASH at AASLD’s The Liver Meeting® 2020
November 02 2020 - 7:00AM
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 clinical data from
its Phase 1b/2a study evaluating BIO89-100, a long-acting
glycoPEGylated FGF21 analog, in patients with nonalcoholic
steatohepatitis (NASH) will be presented in a late-breaking poster
at The Liver Meeting Digital Experience™ 2020 of the American
Association for the Study of Liver Diseases (AASLD) to be held
November 13 - 16. 89bio will also be presenting a poster on
preclinical data demonstrating that BIO89-100’s receptor activation
profile was similar to that of native FGF21.
The late-breaking poster details the promising clinical profile
of BIO89-100 in NASH as measured by MRI-PDFF and other
liver-related metabolic parameters, a favorable safety/tolerability
profile, and potential best-in-class dosing. The presentation
details are as follows:
Abstract Number:
LP34Poster Title: BIO89-100
Demonstrated Robust Reductions in Liver MRI-PDFF, Favorable
Tolerability and Potential for Every 2 Weeks Dosing in a Phase
1b/2a Placebo-Controlled, Double Blind, Multiple Ascending Dose
Study in NASHPresenting Author: Dr. Rohit
Loomba, Director, NAFLD Research Center, Professor of Medicine,
University of California at San DiegoAbstract
Number: 514Poster Title: BIO89-100, A
Novel Glycopegylated Fibroblast Growth Factor 21 (FGF21), Activates
FGF Receptors (FGFR) 1c, 2c, and 3c but not FGFR4 in L6 Cells
Transfected With the Four Different Human FGFRS and Beta Klotho
(KLB)Presenting Author: Dr. Moti Rosenstock,
Preclinical Development, 89bio, Inc.
About NASHNASH is the most advanced stage of
nonalcoholic fatty liver disease (NAFLD). It is a complex metabolic
disorder that causes fat buildup in the liver, as well as
inflammation and eventually fibrosis, and it can worsen to
cirrhosis and liver failure. NASH affects more than 16 million
adults in the United States, and by 2030 its prevalence is
predicted to increase by 63 percent. The exact cause of NASH is
unknown, but it is commonly found in people with obesity and type 2
diabetes. While there are currently no approved treatments, the
biopharmaceutical industry is actively involved in addressing this
unmet medical need.
About the Phase 1b/2a StudyThis clinical study
was a multicenter, randomized, double-blind, placebo-controlled,
multiple ascending dose-ranging trial. It was designed to assess
the safety, tolerability, and PK properties of BIO89-100 as well as
change in liver fat measured by MRI-PDFF and key biomarker
assessments in subjects with biopsy-proven NASH with fibrosis or
subjects with phenotypical NASH (PNASH). PNASH was defined as
patients with steatosis greater than 10% who have central obesity
and Type 2 diabetes or central obesity and evidence of liver
injury. Both populations that were enrolled had similar disease
characteristics at baseline. A total of 81 subjects were randomized
to receive weekly or every two weeks subcutaneous dosing of
BIO89-100 or placebo for up to 12 weeks. Results observed across
all dose groups from the trial add to a growing body of evidence
demonstrating the promise of BIO89-100 for the treatment of NASH.
Results showed robust reductions in liver fat and key liver
markers. Strong efficacy and favorable tolerability were observed
with weekly and every two-week dosing.About
BIO89-100BIO89-100 is a glycoPEGylated analog of FGF21
being developed for the treatment of NASH. 89bio has optimally
engineered BIO89-100 using a proprietary glycoPEGylation technology
to balance efficacy and longer dosing interval. Recent Phase 1b/2a
data show BIO89-100 demonstrated a favorable safety and
tolerability profile and robust reductions in liver fat and key
lipid markers when dosed weekly (QW) or once every two weeks (Q2W).
BIO89-100 is also being developed for the treatment of severe
hypertriglyceridemia (SHTG) and is currently in a Phase 2
trial.
About 89bio89bio 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, BIO89-100, is a specifically engineered glycoPEGylated
analog of FGF21. BIO89-100 is being developed for the treatment of
nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia
(SHTG). 89bio is headquartered in San Francisco with operations in
Herzliya, Israel.
Investor Contact:Ryan MartinsChief Financial
Officerinvestors@89bio.com
Media Contact:Peter
Duckler773-343-3069pduckler@w2ogroup.com
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