Akero Therapeutics to Present Results from Phase 2b SYMMETRY Study Investigating Efruxifermin in Patients with Compensated Cirrhosis Due to NASH
October 09 2023 - 4:05PM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic disease marked by high unmet medical need, will hold an
investor conference on Tuesday, October 10 at 8:00 a.m. ET to share
topline week 36 results from its SYMMETRY study, a double-blind,
placebo-controlled Phase 2b study evaluating the efficacy of
efruxifermin (EFX) in patients with compensated cirrhosis due to
non-alcoholic steatohepatitis (NASH). The topline results will
include histology and changes from baseline in non-invasive
measures of fibrosis, glycemic control, and lipoproteins as well as
safety and tolerability.
Conference Call / Webcast DetailsThe company
will host a conference call and webcast with slide presentation at
8:00 a.m. ET on Tuesday, October 10. Please click
here to register for the event.
The live webcast will be available on the Events &
Presentations page of the Akero website, with the recording and
presentation available immediately following the event.
About NASHNASH is a serious form of
non-alcoholic fatty liver disease (NAFLD) that is estimated to
affect 17 million Americans. NASH is characterized by an excessive
accumulation of fat in the liver that causes stress and injury to
liver cells, leading to inflammation and fibrosis, which can
progress to cirrhosis, liver failure, cancer and eventually death.
There are no approved treatments for the condition and NASH is the
fastest growing cause of liver transplants and liver cancer in the
US and Europe.
About SYMMETRY The Phase 2b SYMMETRY main study
is a multicenter, randomized, double-blind, placebo-controlled,
clinical trial in biopsy-confirmed NASH patients with compensated
cirrhosis (F4, Child-Pugh class A). One hundred eighty-two patients
have been randomized to receive once-weekly subcutaneous dosing of
28mg efruxifermin (EFX), 50mg EFX, or placebo. The primary endpoint
for the trial is the proportion of subjects who achieve ≥ 1 stage
improvement in fibrosis with no worsening of NASH at week 36.
Secondary endpoints include the proportion of patients who achieve
NASH resolution with no worsening of fibrosis, the proportion of
patients who achieve ≥ 1 stage improvement in fibrosis and NASH
resolution, change from baseline to week 36 in non-invasive markers
of liver injury and fibrosis, glycemic control, lipoproteins, and
body weight, as well as evaluation of safety and tolerability.
Patients will continue to receive EFX or placebo for up to 96
weeks.
In June 2023, Akero reported topline data from an expansion
cohort (N=31) of the Phase 2b SYMMETRY study known as Cohort D. The
primary aim of the 12-week study was to assess safety and
tolerability of EFX compared to placebo when added to an existing
GLP-1 receptor agonist (GLP-1) in patients with Type 2 diabetes and
F1-F3 liver fibrosis due to NASH. Results of the Cohort D study
showed safety and tolerability endpoints were met. The study also
showed that adding EFX to GLP-1 therapy significantly improved
non-invasive markers of NASH-related disease, including a 65%
relative reduction in liver fat for the EFX-treated group compared
with a 10% reduction for the placebo group treated only with GLP-1.
Consequently, 88% of EFX-treated patients normalized their liver
fat to 5% or less, compared with 10% for the placebo group.
About EfruxiferminEfruxifermin (EFX) is Akero’s
lead product candidate for NASH, currently being evaluated in the
ongoing Phase 2b HARMONY and SYMMETRY studies. EFX is designed to
reduce liver fat and inflammation, reverse fibrosis, increase
insulin sensitivity and improve lipids. This holistic approach
offers the potential to address the complex, multi-system disease
state of NASH, including improvements in lipoprotein risk factors
linked to cardiovascular disease – the leading cause of death in
NASH patients. Engineered to mimic the biological activity profile
of native FGF21, EFX is designed to offer convenient once-weekly
dosing and has been generally well-tolerated in clinical trials to
date.
About Akero TherapeuticsAkero Therapeutics
is a clinical-stage company developing transformational treatments
for patients with serious metabolic diseases marked by high unmet
medical need, including NASH, a disease without any approved
therapies. Akero's lead product candidate, EFX, is a differentiated
Fc-FGF21 fusion protein that has been engineered to mimic the
balanced biological activity profile of native FGF21, an endogenous
hormone that alleviates cellular stress and regulates metabolism
throughout the body. EFX is designed to offer convenient
once-weekly subcutaneous dosing. EFX is currently being evaluated
in two Phase 2b clinical trials: the HARMONY study in patients with
pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in
patients with cirrhotic NASH (F4 fibrosis, compensated). Akero is
headquartered in South San Francisco. Visit us at akerotx.com
and follow us on LinkedIn and Twitter for more
information.
Forward Looking Statements Statements contained
in this press release regarding matters that are not historical
facts are "forward-looking statements'' within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements, including, but not limited to,
statements regarding: Akero’s business plans and objectives,
including future plans or expectations for EFX, including the
continued dosing of patients for up to 96 weeks with EFX or
placebo; the anticipated or potential therapeutic effects of EFX,
as well as the dosing, safety and tolerability of EFX; and upcoming
milestones, including the results, and expected timing to report
the topline week 36 results of Akero’s Phase 2b SYMMETRY study. Any
forward-looking statements in this press release are based on
management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the success, cost, and timing of Akero’s
product candidate development activities and planned clinical
trials; Akero’s ability to execute on its strategy; positive
results from any of its clinical studies may not necessarily be
predictive of the results of future or ongoing clinical studies;
regulatory developments in the United States and foreign countries;
Akero’s ability to fund operations; as well as those risks and
uncertainties set forth more fully under the caption "Risk
Factors'' in Akero’s most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q, as filed with the Securities and
Exchange Commission (SEC) as well as discussions of potential
risks, uncertainties and other important factors in Akero’s other
filings and reports with the SEC. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Akero undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Investor Contact:Austin
Murtagh212.698.8696IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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