SAN FRANCISCO, Sept. 30, 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 the
company has completed enrollment of a cohort of patients with NASH
who have compensated cirrhosis (F4), Child-Pugh Class A.
A total of 30 cirrhotic NASH subjects with a biopsy-confirmed
fibrosis score of F4 have been randomized 2:1 to receive either
50mg of efruxifermin (EFX) or placebo for 16 weeks. The primary
objective of the expansion cohort is to assess safety and
tolerability of EFX in NASH patients at the greatest risk of
progressing to end-stage liver disease, including liver failure and
liver cancer. The trial design includes various non-invasive
measures of liver health, including fibrosis markers such as the
Enhanced Liver Fibrosis (ELF) score and Pro-C3, as well as liver
imaging.
"We are pleased to have had an opportunity early in our NASH
development program to assess whether EFX has the potential to
improve clinical outcomes for NASH patients with biopsy-confirmed
compensated cirrhosis (F4), Child-Pugh Class A. These patients
could benefit from therapeutic treatment options because they are
at the highest risk of progressing to liver failure or liver cancer
from NASH," said Kitty Yale, chief
development officer of Akero. "Successful enrollment of this
expansion cohort amidst the ongoing COVID-19 pandemic is a
testimony to the attractiveness of EFX's emerging profile as a
potential treatment for NASH."
The company expects to report the results of the F4 expansion
cohort in the first half of 2021.
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.
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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/akero-therapeutics-completes-enrollment-of-cohort-of-cirrhotic-f4-patients-in-ongoing-balanced-study-301141684.html
SOURCE Akero Therapeutics, Inc.