89bio Presents Updated Clinical Data from Positive Phase 1b/2a Study of BIO89-100 in NASH at AASLD’s The Liver Meeting® 20...
November 13 2020 - 8:00AM
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 updated data from its
positive Phase 1b/2a study of BIO89-100, a long-acting
glycoPEGylated FGF21 analog, in patients with nonalcoholic
steatohepatitis (NASH). Previously disclosed topline data
demonstrated reductions in liver fat with concurrent beneficial
effects on lipids and other metabolic parameters, as well as
favorable tolerability, with both weekly and every two-week dosing.
New analyses from the trial will be presented today in a
late-breaking poster (abstract #LP34) at The Liver Meeting Digital
Experience™ 2020 of the American Association for the Study of Liver
Diseases (AASLD).
“I believe that these data highlight BIO89-100’s
robust potency in reducing liver fat as assessed by MRI-PDFF over a
12-week period. New analyses of the data demonstrate the strong and
significant correlation between relative reductions in MRI-PDFF and
serum ALT in patients treated with BIO89-100. Responses on these
two measures have been shown to translate into histology
improvement and potentially a clinically meaningful benefit in
patients with NASH,” said Rohit Loomba, MD, MHSc, Director of the
UC San Diego NAFLD Research Center and Director of Hepatology at UC
San Diego School of Medicine. “We saw a remarkable consistency of
results across the sub-populations of biopsy-confirmed NASH and
phenotypic NASH (PNASH) patients enrolled in the trial. Baseline
characteristics were similar across these sub-populations and
BIO89-100 treatment resulted in similar reductions in liver fat,
ALT, and triglycerides.”
“We are moving forward with a comprehensive
clinical development program designed to build upon the promising
results from BIO89-100’s Phase 1b/2a trial, which includes plans to
initiate a Phase 2b study in the first half of 2021 and an
open-label paired biopsy histology cohort in the near-term. Today’s
data are encouraging for these planned studies as we believe they
demonstrate BIO89-100’s compelling risk-benefit profile as a
leading FGF21 analog in a class that could become a key part of the
NASH treatment paradigm,” said Rohan Palekar, Chief Executive
Officer, 89bio.
A copy of the poster presentation, entitled
“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 NASH,” is available on the AASLD website and is also
available for download via the 89bio website.
The data presented show:
- Similar reductions in liver fat,
ALT and triglycerides between biopsy-confirmed NASH and PNASH
patients treated with BIO89-100 and, importantly, their similar
baseline characteristics underscored the consistency across these
two sub-populations of patients enrolled in the trial.
- Pharmacokinetics of BIO89-100
demonstrated dose proportional PK.
- Positive and highly significant
correlation (r=0.540, p<0.001) between relative reduction in
liver fat by MRI-PDFF and ALT reduction at Week 13.
- Treatment with BIO89-100 (N=81)
resulted in significant reductions in liver fat on MRI-PDFF at Week
13 across all dose groups vs. placebo, with up to 70% and 60%
relative reductions for the 27mg-QW and 36mg-Q2W dose groups vs.
placebo, respectively (p<0.001).
- Significant proportion of patients
responded to therapy with up to 88% and 71% of patients achieving a
≥30% and a ≥50% reduction in liver fat vs. baseline,
respectively.
- Significant benefit in markers of
liver injury and fibrosis, with up to 44% reduction in ALT and a 35
Units/Liter (U/L) decrease in patients with high ALT was
observed.
- Significant improvements were also
observed in triglycerides. Reductions in TGs was more pronounced in
patients who had higher levels of TGs at baseline.
- Improvements were also noted across
the spectrum of metabolic marker data vs. placebo for the 27mg QW
dose group including HOMA-IR, glucose, HbA1c, weight (p<0.05)
and adiponectin (p<0.001).
- BIO89-100 was well-tolerated across
all doses with no deaths or serious adverse events related to
treatment and a low incidence of treatment-related adverse events
(TRAEs) that occurred in ≥ 10% of patients.
- Low frequency of gastrointestinal
(GI) related adverse events was observed with a profile for
BIO89-100 that was similar to placebo. Low rates of diarrhea (9.5%
vs. 11.1% for placebo) and nausea (4.8% vs. 11.1% for placebo) and
importantly, no vomiting were reported in BIO89-100 treated
patients. No hypersensitivity AEs, few mild injection site reaction
events, no tremor and no adverse effects on heart rate or blood
pressure were observed.
About
NASH NASH
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
Study This
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 patients with biopsy-proven NASH with
fibrosis or patients 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 patients 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. A strong efficacy profile and favorable tolerability were
observed with weekly and every two-week dosing.About
BIO89-100 BIO89-100
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.
Forward-looking
Statements Certain
statements in this press release may constitute "forward-looking
statements" within the meaning of the federal securities laws,
including, but not limited to, the therapeutic potential and
clinical benefits of BIO89-100, the safety and tolerability of
BIO89-100, future clinical development plans for BIO89-100,
including the Phase 2b study and open-label paired biopsy histology
cohort and the anticipated timing for such plans. Words such as
"may," "might," "will," "objective," "intend," "should," "could,"
"can," "would," "expect," "believe," "design," "estimate,"
"predict," "potential," "develop," "plan" or the negative of these
terms, and similar expressions, or statements regarding intent,
belief, or current expectations, are forward looking statements.
While 89bio believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are based upon 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 89bio's control and subject to change. Actual
results could be materially different. Risks and uncertainties
include: expectations regarding the timing and outcome of 89bio’s
initiation of the next trial in NASH; 89bio’s ability to execute on
its strategy; positive results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical studies; the effect of the COVID-19 pandemic on 89bio’s
clinical trials and business operations, and the impact of general
economic, health, industrial or political conditions in the United
States or internationally; and other risks and uncertainties
identified in 89bio's Annual Report on Form 10-K for the year ended
December 31, 2019 and its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020 and other subsequent disclosure
documents filed with the SEC. 89bio claims the protection of the
Safe Harbor contained in the Private Securities Litigation Reform
Act of 1995 for forward-looking statements. 89bio expressly
disclaims any obligation to update or alter any statements whether
as a result of new information, future events or otherwise, except
as required by law.
Investor Contact:Ryan MartinsChief Financial
Officerinvestors@89bio.com
Media Contact:Peter
Duckler773-343-3069pduckler@w2ogroup.com
89bio (NASDAQ:ETNB)
Historical Stock Chart
From Mar 2024 to Apr 2024
89bio (NASDAQ:ETNB)
Historical Stock Chart
From Apr 2023 to Apr 2024