Akero Therapeutics Announces First Patient Dosed in Phase 3 SYNCHRONY Outcomes Study of Efruxifermin in Patients with Compensated Cirrhosis Due to MASH
September 09 2024 - 7:00AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage
company developing transformational treatments for patients with
serious metabolic diseases marked by high unmet medical need, today
reported the first patient was dosed in the Phase 3 SYNCHRONY
Outcomes trial. The study will evaluate the efficacy and safety of
EFX for the treatment of compensated cirrhosis, fibrosis stage 4
(F4), due to metabolic dysfunction-associated steatohepatitis
(MASH).
“Dosing the first patient in the SYNCHRONY Outcomes trial is an
exciting milestone that rounds out our Phase 3 SYNCHRONY program
evaluating EFX in patients with varied levels of MASH severity.
There continues to be a substantial unmet need for treatments that
delay or prevent liver failure among patients with MASH, and the
SYNCHRONY program has the potential to show that treatment with EFX
can do so in different stages of disease progression,” said Kitty
Yale, chief development officer of Akero. “We look forward to
advancing clinical development of EFX as a potentially
differentiated therapeutic for liver fibrosis and cirrhosis as well
as metabolic dysregulation.”
Outcomes is part of Akero’s broader SYNCHRONY Phase 3 program,
which includes two other ongoing, randomized, placebo-controlled
trials that began enrolling patients in the fourth quarter of 2023.
SYNCHRONY Histology is evaluating the efficacy and safety of EFX in
patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3), while
SYNCHRONY Real-World, is assessing the safety and tolerability of
EFX in patients with non-invasively diagnosed MASH or metabolic
dysfunction-associated steatotic liver disease (MASLD) (F1-F4). The
SYNCHRONY program is evaluating extent of improvement in fibrosis
and resolution of MASH, as well as liver-related long-term clinical
outcomes and all cause mortality, with the potential to support
marketing applications for treatment of both pre-cirrhotic liver
fibrosis and compensated cirrhosis due to MASH.
In all Phase 3 studies, patients are self-administering EFX
using the LyoJect 3S dual chamber syringe, a pre-filled device
intended for commercial use in the event EFX is approved for
marketing.
Week 96 results from the ongoing Phase 2b SYMMETRY study,
evaluating the efficacy and safety of EFX in patients with
compensated cirrhosis due to MASH (F4), are anticipated in the
first quarter of 2025.
About EfruxiferminEfruxifermin (EFX), Akero’s
lead product candidate for MASH, 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 appears to reduce liver fat and inflammation, reverse
fibrosis, increase insulin sensitivity and improve lipid
metabolism. This holistic approach offers the potential to address
the complex, multi-system disease state of MASH, including
improvements in lipoprotein risk factors linked to cardiovascular
disease – the leading cause of death in MASH patients. EFX is
designed to offer convenient once-weekly dosing and has been
generally well tolerated in clinical trials to date.
About MASHMASH is a serious form of MASLD that
is estimated to affect more than 17 million Americans. MASH 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. MASH is the fastest growing cause of
liver transplants and liver cancer in the US and Europe.
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 MASH. Akero's lead product candidate, EFX,
is currently being evaluated in the ongoing SYMMETRY study, a
96-week Phase 2b clinical trial in patients with compensated
cirrhosis due to MASH (F4 fibrosis), as well as three ongoing Phase
3 clinical trials in patients with pre-cirrhotic MASH or
compensated cirrhosis due to MASH:
SYNCHRONY Histology,
SYNCHRONY Real-World, and
SYNCHRONY Outcomes. The SYNCHRONY program
builds on the results of two Phase 2b clinical trials, the HARMONY
study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY
study in patients with compensated cirrhosis due to MASH (F4) in
which patients have been treated for up to 96 weeks. Akero is
headquartered in South San Francisco. Visit us at akerotx.com
and follow us on LinkedIn and X for more
information.
Forward Looking StatementsStatements 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; expectations
regarding the SYNCHRONY Phase 3 clinical trials, including that of
the Phase 3 SYNCHRONY Outcomes trial; the timing to report results
of the ongoing Phase 2b SYMMETRY Study; and the therapeutic effects
of EFX as well as the dosing, safety and tolerability of EFX. 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 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; 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:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:Peg
Rusconi617.910.6217peg.rusconi@deerfieldgroup.com
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