Akero Therapeutics Announces First Patients Dosed in Efruxifermin Phase 3 SYNCHRONY Program
December 18 2023 - 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 patients have received their first doses of efruxifermin
(EFX) in the SYNCHRONY Phase 3 program. Two parallel, randomized,
placebo-controlled trials have commenced: SYNCHRONY Histology
evaluating the efficacy and safety of EFX in patients with
biopsy-confirmed pre-cirrhotic nonalcoholic
steatohepatitis/metabolic dysfunction-associated steatohepatitis
(NASH/MASH), and SYNCHRONY Real-World assessing safety and
tolerability of EFX in patients with non-invasively diagnosed
NASH/MASH or non-alcoholic fatty liver disease/metabolic
dysfunction-associated steatotic liver disease (NAFLD/MASLD).
“We are thrilled to have dosed the first patients in our Phase 3
program and are delighted with the current level of engagement by
clinicians and patients,” said Kitty Yale, chief development
officer of Akero. “We look forward to advancing the clinical
development of EFX for both pre-cirrhotic and cirrhotic NASH/MASH
as we strive to bring meaningful therapies to patients.”
SYNCHRONY Histology is expected to enroll approximately 1,000
patients with biopsy-confirmed NASH/MASH, fibrosis stage 2 or 3
(F2-F3) to receive weekly injections of EFX 28mg, EFX 50mg, or
placebo. The primary endpoint, to support an application for
accelerated approval, is the proportion of patients experiencing ≥
1-stage fibrosis improvement AND resolution of NASH/MASH after 52
weeks of treatment. After 52 weeks, patients will continue
treatment as randomized in SYNCHRONY Histology to be followed for
long-term clinical outcomes, such as progression to cirrhosis.
SYNCHRONY Real-World is expected to enroll approximately 600
patients with NASH/MASH or NAFLD/MASLD diagnosed by non-invasive
tests to receive weekly injections of EFX 50mg or placebo. The
primary endpoint of safety and tolerability will be assessed after
52 weeks of treatment. Key secondary endpoints in both the
Histology and Real-World studies include changes from baseline in
markers of liver injury and fibrosis, glycemic control and
lipids.
In all EFX Phase 3 studies, patients will self-administer EFX
using the LyoJect 3S dual chamber syringe, a pre-filled device
intended for commercial use in the event EFX is approved for
marketing. This optimized formulation delivers blood levels of EFX
comparable to those of the liquid formulation used in prior
clinical studies.
End-of-Phase 2 FDA Meeting to Discuss SYNCHRONY
Outcomes
An FDA Type B, End-of-Phase-2 meeting has been scheduled
for the first quarter of 2024 to review the design of the planned
SYNCHRONY Outcomes study evaluating EFX in the treatment of
NASH/MASH patients with compensated cirrhosis (F4). SYNCHRONY
Outcomes, as proposed to FDA, will evaluate regression of fibrosis
based on histology, with the potential to support applications for
accelerated and conditional approval in the United States and
Europe, respectively, and follow patients with cirrhosis for
long-term clinical outcomes to support full approval.
Readout of Week 96 Phase 2b HARMONY Results
All week 96 visits for the Phase 2b HARMONY study, evaluating
EFX for the treatment of pre-cirrhotic NASH/MASH (F2-F3), have been
completed. Final 30-day follow-up visits are expected to be
completed during January 2024 with results expected to be reported
in March 2024.
About EfruxiferminEfruxifermin, Akero’s lead
product candidate for treatment of NASH/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 is designed to reduce liver fat and
inflammation, reverse fibrosis, increase insulin sensitivity and
improve lipids. This holistic approach offers the potential to
address the complex, multi-system disease state of NASH/MASH,
including improvements in lipoprotein risk factors linked to
cardiovascular disease – the leading cause of death in NASH/MASH
patients. EFX is designed to offer convenient once-weekly dosing
and has been generally well-tolerated in clinical trials to
date.
About NASH/MASH NASH/MASH is a serious form of
NAFLD/MASLD that is estimated to affect 17 million Americans.
NASH/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. Approximately 20% of patients
with NASH/MASH will progress to cirrhosis, which has a higher risk
of mortality. There are no approved treatments for the condition
and NASH/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 NASH/MASH, a disease without any approved
therapies. Akero's lead product candidate, EFX, is currently being
evaluated in two ongoing, 96-week Phase 2b clinical trials, the
HARMONY study in patients with pre-cirrhotic NASH/MASH (F2-F3
fibrosis), and the SYMMETRY study in patients with cirrhotic
NASH/MASH (F4 fibrosis, compensated), as well as two Phase 3
clinical trials, the SYNCHRONY Histology study in patients with
pre-cirrhotic NASH/MASH (F2-F3 fibrosis) and the SYNCHRONY
Real-World study in patients with NASH/MASH or NAFLD/MASLD. Akero
is headquartered in South San Francisco. Visit us
at akerotx.com and follow us on LinkedIn and Twitter 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; the
potential therapeutic effects of EFX, as well as the dosing, safety
and tolerability of EFX; the SYNCHRONY Phase 3 program, including
the SYNCHRONY Histology and SYNCHRONY Real-World studies and design
of trials, the ongoing enrollment of Akero’s Phase 3 SYNCHRONY
program; expectations regarding communications with the FDA; and
upcoming milestones, including the results, and expected timing to
report the long-term follow-up week 96 results of Akero’s Phase 2b
HARMONY study. 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 any of its clinical studies 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:Austin
Murtagh212.698.8696IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
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