SOUTH SAN FRANCISCO, Calif.,
Sept. 24, 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 written guidance from the U.S. Food and Drug
Administration (FDA) enables the company to implement an innovative
combined Phase 2b/3 study design for
pivotal efruxifermin (EFX) trials in NASH patients.
Under the planned adaptive trial design, Akero will evaluate two
EFX doses in a 24-week Phase 2b
portion of the trial to inform selection of a single dose for
evaluation in the Phase 3 portion of the study. The company remains
on track to initiate a Phase 2b/3
trial of EFX in biopsy-confirmed NASH patients in the first half of
2021.
"We are pleased that the FDA found our overall proposed adaptive
Phase 2b/3 development program to be
acceptable, and we are grateful for the additional clarity the
agency provided as we finalize our study protocol," said
Andrew Cheng, M.D., Ph.D., president
and chief executive officer of Akero. "We believe that the positive
histological data in biopsy-confirmed NASH patients obtained from
the BALANCED study provided the foundation necessary to align on an
adaptive Phase 2b/3 trial design.
Further analysis of data from the BALANCED study has strengthened
our confidence in EFX's potential to be a foundational monotherapy
in NASH."
The company will present the results of additional analyses from
the BALANCED study at an upcoming scientific meeting.
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 is designed to increase insulin
sensitivity, improve lipoproteins, reduce liver fat and
inflammation, and reverse fibrosis. This holistic approach offers
the potential to address the complex, multi-organ/tissue
pathogenesis 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 human FGF21, EFX offers convenient
once-weekly dosing.
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; Akero's Phase 2a
BALANCED study, including its results and expected timing to report
the analysis of additional data; expectations regarding the design,
implementation, timing, and success of its current and planned
clinical trials for EFX; expectations regarding successful scale-up
of drug substance manufacturing and release of new drug product for
use in clinical trials; and the potential impact of COVID-19 on
strategy, future operations, enrollment 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.