89bio Provides Business Outlook for 2021
January 05 2021 - 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 provided a corporate update,
including its roadmap for advancing BIO89-100 in 2021.
“We are extremely pleased by our 2020 progress
across all aspects of the company including clinical, manufacturing
and corporate advancements,” said Rohan Palekar, chief executive
officer of 89bio. “We are steadily executing across our clinical
development program for BIO89-100, a potentially best-in-class
FGF21 analog engineered to achieve superior efficacy, optimal
dosing convenience, as well as favorable safety and tolerability.
In 2020, we presented encouraging topline Phase 1b/2a data, which
has informed the advancement of our clinical strategy in NASH and
we are looking forward to our major anticipated milestones in 2021
in both NASH and SHTG.”
Key 2021 Milestones
- Report topline data from the
paired-biopsy, open-label histology cohort as part of the Phase
1b/2a trial of BIO89-100 in NASH by year-end 2021
- Initiate the Phase 2b NASH trial as
part of a potential Phase 2b/3 program in the first half of
2021
- Report topline data from the Phase
2 trial of BIO89-100 in SHTG in the second half of 2021
Clinical Development
Overview89bio is developing BIO89-100, a glycoPEGylated
analog of FGF21 for the treatment of liver and cardio-metabolic
diseases. BIO89-100 delivers a compelling risk-benefit profile by
improving liver pathology and addressing the underlying metabolic
issues while balancing these benefits with favorable tolerability
and the dosing convenience necessary for adoption and
compliance.
NASH 89bio plans to initiate a Phase 2b NASH
trial as part of a potential Phase 2b/3 trial in the first half of
2021. Additionally, the Company recently initiated a paired-biopsy,
open-label histology cohort as part of the Phase 1b/2a trial of
BIO89-100 in NASH, with data anticipated by the end of 2021. This
cohort will enroll approximately 20 patients with biopsy-confirmed
NASH and will provide an early opportunity to demonstrate
BIO89-100’s benefits on histology endpoints. These patients will be
treated for 20 weeks with 27 mg of BIO89-100 once weekly. The
cohort will build on the recent data from 89bio’s Phase 1b/2a
multicenter, randomized, double-blind, placebo-controlled, multiple
ascending dose-ranging trial. The 13-week trial enrolled a total of
81 patients and demonstrated relative reductions in liver fat of up
to 70% versus placebo, as measured by magnetic resonance
imaging—proton density fat fraction (MRI-PDFF). A majority of
patients achieved a ≥ 30% (up to 88%) or a ≥ 50% (up to 71%)
reduction in liver fat. ALT was significantly reduced (up to 44%)
in these patients and key lipid markers like triglycerides, LDL,
and non-HDL were also significantly improved. Results were
consistent across the sub-populations of biopsy-confirmed NASH and
phenotypic NASH (PNASH) patients enrolled in the trial and baseline
characteristics were similar across these sub-populations as were
the reductions in liver fat. The percentage of responders on
MRI-PDFF and BIO89-100’s effect on reducing ALT and triglycerides
were also similar across these sub-populations. Overall, BIO89-100
had a favorable safety and tolerability profile with rates of
gastrointestinal side effects such as nausea, diarrhea and vomiting
similar to placebo.
SHTGThe ongoing Phase 2 trial investigating
BIO89-100 for the treatment of severe hypertriglyceridemia (SHTG)
will enroll approximately 90 patients. In this Phase 2
multi-center, randomized, double-blind, placebo-controlled study
designed to evaluate safety, efficacy, and tolerability, BIO89-100
or placebo will be administered in one of four treatment groups
either weekly or every two weeks. The primary endpoint is the
reduction in fasting triglycerides from baseline. Key secondary
endpoints include the effect of BIO89-100 on other lipids and
metabolic markers and change in liver fat measured by MRI-PDFF.
Topline data from the study are expected in the second half of
2021.
Participation in the 10th Annual LifeSci
Partners Corporate Access Event Rohan Palekar, chief
executive officer of 89bio, will participate in 1x1 meetings with
investors at the upcoming Annual LifeSci Partners Corporate Access
Event, which will take place January 6-8 and 11-14, 2021.
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, 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, clinical development plans for
BIO89-100, including the Phase 2b trial and open-label paired
biopsy histology cohort for NASH and the Phase 2 trial for SHTG,
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 Phase
2b trial in NASH; expectations regarding the timing of topline
data; 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 Martins Chief Financial
Officer investors@89bio.com
Media Contact: Peter Duckler 773-343-3069
pduckler@w2ogroup.com
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