89bio Initiates Phase 2 Trial of BIO89-100 in Patients with Severe Hypertriglyceridemia
03 September 2020 - 10:30PM
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 the initiation of a
Phase 2 trial evaluating its product candidate BIO89-100 in
patients with severe hypertriglyceridemia (“SHTG”). BIO89-100 is a
glycoPEGylated analog of fibroblast growth factor 21 (“FGF21”) in
clinical development for the treatment of nonalcoholic
steatohepatitis (“NASH”) and SHTG.
"This new program builds on our strategy to leverage the biology
of FGF21 to bring meaningful benefit to patients across a range of
serious diseases with high unmet needs," said Hank Mansbach, Chief
Medical Officer of 89bio. “Existing therapies for SHTG do not
address the range of metabolic issues faced by these patients, that
result in the increased risk of cardiovascular events and NASH. Our
early clinical data indicate that BIO89-100 could offer robust and
durable reductions in triglycerides as well as deliver broad
metabolic benefits. This suggests BIO89-100 has the potential to be
a highly differentiated new therapy for this condition."
The Phase 2 trial is a multi-center, randomized, double-blind,
placebo-controlled study designed to evaluate the safety, efficacy,
and tolerability of BIO89-100 in patients with SHTG. The study will
enroll approximately 90 patients who will be treated with BIO89-100
in one of four treatment groups or placebo administered in either
weekly or every two weeks doses for a period of 8 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 magnetic resonance imaging proton density fat fraction
(MRI-PDFF). Patients who meet screening criteria will undergo a
lifestyle stabilization and triglyceride qualification period prior
to randomization and will receive lifestyle counseling during the
study.
About Severe Hypertriglyceridemia SHTG is a
condition identified by severely elevated levels of triglycerides
(greater than or equal to 500 mg/dL). It is associated with an
increased risk of NASH, cardiovascular events, and acute
pancreatitis. It is estimated that up to 4 million patients in
the United States have SHTG. Of these patients, it is estimated
that 56% have hepatic fat, 42% have dyslipidemias and 27% have
diabetes. This patient population is expected to increase due to
the triple epidemic of obesity, metabolic syndrome, and Type 2
diabetes. While existing therapies may decrease triglyceride
levels, they generally do not have broader metabolic benefits
underscoring the urgent need for additional therapeutic
options.
About BIO89-100 BIO89-100 is a glycoPEGylated
analog of FGF21 being developed for the treatment of NASH and SHTG.
89bio has optimally engineered BIO89-100 using a proprietary
glycoPEGylation technology to balance efficacy and longer dosing
interval. In preclinical studies, BIO89-100 demonstrated
significant improvements in hepatic steatosis, injury, and
fibrosis. In 89bio's Phase 1a clinical trial of BIO89-100 in
healthy volunteers, BIO89-100 demonstrated robust and durable
improvements in key lipid markers, a favorable tolerability
profile, and a long half-life that supports the potential for
weekly or once every two weeks dosing.
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. 89bio’s lead product candidate
is BIO89-100, a specifically engineered glycoPEGylated analog of
FGF21. BIO89-100 is being developed for the treatment of NASH and
SHTG with ongoing proof of concept studies in both indications.
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, 89bio's expectations regarding its new clinical
program and clinical trials, the association of early data with
potential clinical benefit, and the results and timing of
anticipated endpoints. 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,
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 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
June 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
510-390-3407 ryan.martins@89bio.com
Media Contact: Lori Rosen LDR Communications 917-553-6808
lori@ldrcommunications.com
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