89bio Announces Closing of Enrollment in its Phase 1b/2a NASH Trial and Reports New Preclinical Data Confirming BIO89-100’s...
April 13 2020 - 8:30AM
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 it closed
enrollment in its Phase 1b/2a trial for nonalcoholic
steatohepatitis (NASH) with 98% of patients enrolled and has
delayed initiation of its severe hypertriglyceridemia (SHTG) trial
due to the ongoing COVID-19 pandemic. 89bio also reported new
preclinical data confirming BIO89-100’s mechanism of action via
potent FGF receptor agonism.
“I am extremely proud that our team was able to
close enrollment in our Phase 1b/2a NASH trial with 98% of
patients enrolled, despite the challenging environment related to
the ongoing COVID-19 pandemic. We are monitoring the situation and
will adjust plans if needed to minimize any trial disruption due to
COVID-19. We continue to expect topline data in the second half of
2020,” said Rohan Palekar, Chief Executive Officer of 89bio. “In
addition, we will delay initiation of our Phase 2 trial of
BIO89-100 in SHTG until conditions improve to allow us to execute
the trial safely and efficiently. In the interim, we plan to
complete all preparatory work to enable enrollment as soon as
conditions enable it. We plan to follow the guidelines put forth by
the U.S. Centers for Disease Control and Prevention, as well as
national, state and local governments and make the proactive
decisions necessary to protect the health and safety of all of our
stakeholders.”
The Phase 1b/2a proof-of-concept trial in NASH
is a multicenter, randomized, double-blind, placebo-controlled,
multiple ascending dose-ranging trial in patients with NASH or
patients with NAFLD and a high risk of NASH. In this trial, 81
patients were randomized to receive weekly or every other week
subcutaneous dosing of BIO89-100 or placebo for 12 weeks. The
trial is designed to assess the safety, tolerability and PK
properties of BIO89-100 as well as absolute change from baseline in
hepatic fat fraction measured by magnetic resonance imaging –
proton density fat fraction (MRI-PDFF). MRI-PDFF will be assessed
at week 7 and at end of the trial along with other key biomarkers
that will be evaluated more frequently. 89bio is working closely
with its contract research organization partners and clinical sites
to mitigate any potential impact of the COVID-19 pandemic on the
trial. Topline data is still expected in the second half of 2020
and the Company plans to initiate the Phase 2b trial in the first
half of 2021.
89bio is delaying the initiation of its Phase 2
trial of BIO89-100 for the treatment of SHTG, which was planned for
the first half of 2020. The Company plans to complete all
activities to be operationally prepared to enroll the trial once
the external environment is conducive to executing the trial safely
and effectively.
The Company has adequate clinical supplies for
the ongoing NASH trial and the planned SHTG trial.
New BIO89-100 Preclinical
Data
“Our new preclinical data demonstrates that
BIO89-100 has similar activity to rhFGF21 at FGF receptors 1c, 2c
and 3c, suggesting that BIO89-100 could reproduce the beneficial
metabolic benefits of the native hormone, which may translate into
clinical benefits for patients with NASH and SHTG,” said Dr. Hank
Mansbach, Chief Medical Officer of 89bio.
Activation of the FGF receptors 1c, 2c and 3c,
together with the co-receptor β-klotho, are critical to the
signaling of FGF21 and are believed to be responsible for the
beneficial metabolic effects observed. In an in vitro study of
receptor agonism, BIO89-100 was shown to have activity at very low
nanomolar concentrations in cells co-expressing β-klotho and each
of FGF receptors 1c, 2c or 3c. The EC50 (concentration at which one
half of the maximal FGF receptor agonist effect is observed) for
BIO89-100 was similar across FGF receptors 1c, 2c and 3c and
comparable or superior to that of rhFGF21 in this functional assay.
An EC50 could not be calculated for rhFGF21 or BIO89-100 at FGF
receptor R4.
Investors are encouraged to review the Company’s
updated Corporate Presentation slide deck that provides an overview
of the Company’s business and is available under the “Investors”
tab of the Company’s website at www.89bio.com, or by request to the
Company.
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 being developed for the treatment of NASH. The
company also intends to develop BIO89-100 for the treatment of
SHTG. BIO89-100 is a specifically engineered glycoPEGylated analog
of FGF21 that is currently in a proof of concept Phase 1b/2a
clinical trial in patients with NASH or NAFLD and a high risk of
NASH. 89bio is headquartered in San Francisco with operations in
Herzliya, Israel. Visit 89bio.com for more information.
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, 89bio’s
expectations regarding plans for its clinical programs and clinical
trials, the association of preclinical data with potential clinical
benefit and timing of anticipated milestones. 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 U.S. Securities and Exchange
Commission (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
completion and outcome of 89bio’s Phase 1b/2a proof of concept
clinical trial evaluating BIO89-100 in patients with NASH or
patients with NAFLD and a high risk of NASH; expectations regarding
the timing, completion and outcome of 89bio’s proof of concept
Phase 2 clinical trial evaluating BIO89-100 in patients with SHTG;
the unpredictable relationship between preclinical study results
and clinical study results; the effect of the COVID-19 pandemic on
89bio’s clinical trials and business operations; and other risks
and uncertainties identified in 89bio’s Annual Report on Form 10-K
for the year ended December 31, 2019, filed March 18, 2020 with the
SEC 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: Lori Rosen LDR Communications 917-553-6808
lori@ldrcommunications.com
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