SOUTH SAN FRANCISCO, Calif., Oct.
16, 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
European Medicines Agency (EMA) has granted Priority Medicines
(PRIME) designation to efruxifermin (EFX), an investigational FGF21
analog for the treatment of NASH. The designation was granted based
on the positive efficacy data recently reported from the company's
Phase 2a BALANCED study. Based on available published data, EFX is
believed to be the first drug candidate to receive a PRIME
designation for treatment of NASH.
"We believe the EMA PRIME designation for efruxifermin provides
important validation for the potential of EFX to become a
foundational NASH monotherapy," said Andrew
Cheng, M.D., Ph.D., president and chief executive officer of
Akero. "This designation underscores not only the high level of
unmet need for therapeutics to treat this life-threatening disease,
but also EFX's potential to address multiple aspects of NASH and
its associated comorbidities. We are grateful to the EMA for
considering our application and for recognizing the potential
benefits EFX could provide to patients, if approved."
In reaching its decision, the EMA's Committee on Human Medicinal
Products (CHMP) indicated preliminary 16-week data from Akero's
Phase 2a clinical trial, the BALANCED study of EFX in
biopsy-confirmed NASH patients, show EFX's potential to meet unmet
medical need for NASH therapies by addressing multiple aspects of
NASH-related morbidity and mortality. The CHMP also expressed that
the totality of data, including histology data as well as biomarker
data, together with better glycemic control and amelioration of
dyslipidemia, suggest potential benefit not only for treatment of
NASH but also the broader context of metabolic syndrome common in
NASH patients.
The BALANCED study, which evaluated EFX in treatment of
biopsy-confirmed NASH patients for just 16 weeks, showed that 48%
of all EFX-treated patients achieved at least a one-stage
improvement in fibrosis without worsening of NASH, and 48% of all
EFX patients achieved resolution of NASH without worsening of
fibrosis. Patients treated with EFX also achieved relative
reductions of liver fat ranging from 63-72% across three dose
groups, compared to 0% for placebo. The study also showed that EFX
improved multiple NASH comorbidities, including better glycemic
control and improved lipoprotein profile as well as weight
loss.
The PRIME program is designed to enhance regulatory support in
the EU for the development of promising investigational medicines
that, based on early clinical data, may offer a major therapeutic
advantage over existing treatments, or benefit patients without
treatment options. PRIME aims to provide multiple benefits so that
these medicines can reach patients earlier: enhanced interaction
and early dialogue with EMA, guidance on the overall development
plan and regulatory strategy, and the potential for accelerated
assessment of the marketing authorization application. For more
information please visit the EMA website at www.ema.europa.eu.
The company plans to initiate a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed
NASH patients in the first half of 2021 based on guidance received
from the U.S. Food and Drug Administration.
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 and impacts more than a third of people with type
2 diabetes worldwide. 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 has been shown to increase insulin
sensitivity, improve lipoproteins, reduce 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; the PRIME designation of EFX,
potential benefits resulting from such designation and related
implications; 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.