SOUTH SAN FRANCISCO, Calif., Oct. 2,
2020 /PRNewswire/ -- Akero
Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic
non-alcoholic steatohepatitis (NASH) company developing pioneering
medicines designed to restore metabolic balance and improve
the overall health of NASH patients, today announced that an
abstract detailing additional analyses of the data from its Phase
2a BALANCED study of efruxifermin (EFX) has been accepted for
presentation at The Liver Meeting Digital Experience™ 2020 of the
American Association for the Study of Liver Diseases (AASLD) to be
held November 13 - 16.
The new analyses will be
presented in the presidential plenary oral session by Stephen Harrison, M.D., medical director of
Pinnacle Clinical Research, in a presentation titled "Efruxifermin
(EFX), a long-acting Fc-FGF21 fusion protein, administered for 16
weeks to patients with NASH substantially reduces liver fat and
ALT, and improves liver histology: analysis of a randomized,
placebo-controlled, Phase 2a study (BALANCED)." The abstract was
published in the October supplement of Hepatology, the
peer-reviewed journal of AASLD.
Abstract Title: Efruxifermin (EFX), a long-acting
Fc-FGF21 fusion protein, administered for 16 weeks to patients with
NASH substantially reduces liver fat and ALT, and improves liver
histology: analysis of a randomized, placebo-controlled, Phase 2a
study (BALANCED).
Abstract Number: 8
Presenting Author: Stephen
Harrison, M.D.
Session Date: November 15,
2020
Session Time: 9-10:30 a.m.
ET
About NASH
NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD
(non-alcoholic fatty liver disease) and is estimated to affect 17
million Americans. NASH is closely linked to the obesity and
diabetes epidemics seen around the world. 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. As a result, NASH has become a leading cause of
liver transplants in the US and Europe.
About Efruxifermin
Efruxifermin (EFX), formerly AKR-001, is Akero's lead product
candidate for NASH. EFX increases insulin sensitivity, improves
lipoproteins, reduces liver fat and inflammation, and reverses
fibrosis. The breadth of desirable metabolic effects offers
potential to address the complex, multi-organ/tissue pathogenesis
of NASH, including risk factors linked to cardiovascular disease –
the leading cause of death in NASH patients. Engineered to
mimic the biological activity profile of native human FGF21, EFX
offers convenient once-weekly dosing. Based on guidance from the
U.S. Food and Drug Administration (FDA), EFX will be evaluated in
an innovative adaptive Phase 2b/3
pivotal study in biopsy confirmed NASH patients to be initiated in
the first half of 2021.
About Akero Therapeutics
Akero is a
cardio-metabolic NASH company dedicated to reversing the escalating
NASH epidemic by developing pioneering medicines designed
to restore metabolic balance and improve overall health of
NASH patients. The Company's lead product candidate, efruxifermin,
has been evaluated in a 16-week Phase 2a clinical trial, the
BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information,
please visit www.akerotx.com.
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 the Company's business
plans and objectives, including future plans or expectations for
EFX, upcoming milestones, and therapeutic effects of EFX as well as
the dosing, safety and tolerability of EFX; expectations regarding
the design, implementation, timing, and success of its current and
planned clinical trials for EFX; and the potential impact of
COVID-19 on strategy, future operations, and clinical
trials. 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: risks related to the impact of COVID-19 on the
Company's ongoing and future operations, including potential
negative impacts on Akero's employees, third-parties,
manufacturers, supply chain and production as well as on global
economies and financial markets; the success, cost, and timing of
the Company's product candidate development activities and planned
clinical trials; the Company'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;
regulatory developments in the United States and foreign
countries; the Company's ability to fund operations; as well as
those risks and uncertainties set forth more fully under the
caption "Risk Factors" in Akero's Annual Report on Form 10-K for
the year ended December 31, 2019 and
most recently filed Quarterly Report on 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.
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SOURCE Akero Therapeutics, Inc.